Prehabilitation and rehabilitation nursing: Balance and fall risk in community-dwelling older adults.

i Bruna Raquel Figueira Ornelas de Gouveia Prehabilitation and rehabilitation nursing: Balance and fall risk in community-dwelling older adults. Tese de Candidatura ao grau de Doutor em Ciências de Enfermagem, submetida ao Instituto de Ciências Biomédicas Abel Salazar da Universidade do Porto. Orientadora Doutora Helena Jardim Professora Coordenadora Universidade da Madeira Co-orientadoras Doutora Manuela Martins Professora Coordenadora Escola Superior de Enfermagem do Porto Doutora Debra J. Rose Professora California State University, Fullerton ii iii Contents p. List of tables and figures v Acknowledgments vii Abstract ix Resumo x Chapter 1 - Introduction 3 1.1 Introduction to the study topic 4 1.2 Developing complex interventions in nursing sciences 6 1.3 The nursing theory supporting the approach to older adults 8 1.4 Aims and hypothesis 8 1.5 Operational definition of central concepts 9 1.6 Outline of the thesis 10 1.7 References 11 Chapter 2 Theoretical and scientific background: State of art 15 2.1. The functional consequences theory for promoting wellness in older adults and the concept of prehabilitation 16 2.2. Falls in community-dwelling older adults 19 2.3. Balance in older adults 27 2.4. The ProBalance intervention 39 2.5. References 42 Chapter 3 Method 51 3.1 Study type 52 3.2 Investigation question 52 3.3 Sample and participants 52 3.4 Eligible participants 53 3.5 Recruitment and enrolment 53 3.6 Intervention and control 53 3.7 Outcome and interfering variables 55 3.8 Instruments and assessments 55 3.9 Ethical considerations 59 3.10 Quality control 60 3.11 References 61 iv Chapter 4 Therapeutic exercise in Gerontological Rehabilitation: A literature analysis 63 Chapter 5 The ProBalance Program for improving balance in older adults: A pilot study 79 Chapter 6 The ProBalance Program improves balance and reduces fall risk in community-dwelling older adults from Madeira Island, Portugal: A randomized controlled trial 97 Chapter 7 The effect of the ProBalance Program in strength and gait of community-dwelling older adults from Madeira Island, Portugal: A randomized controlled trial. 113 Chapter 8 Conclusion 132 8.1. Overview of the study findings 133 8.2. Limitations and strengths of the study design 137 8.3. Implications for clinical practice and future directions 137 8.4. References 138 Appendices 139 Appendix I – Sample exercise session plan 140 Appendix II – Educational session plan 144 Appendix III – Individual assessment file 146 Appendix IV – Information to the participants document 176 Appendix V – Informed consent document 182 Appendix VI – Ethics Committee approval document 184 Appendix VII – List of publications 186 v List of tables and figures p. Tables Table 2.1 Biological, behavioral, socioeconomic, and environmental risk factors for falls. 22 Table 4.1 Studies that address posture, gait, and functional fitness components. 70 Table 5.1 Test-retest reliability for balance, gait parameters, functional fitness, health-related quality of life, cognition, falls efficacy, and habitual physical activity: pilot. 88 Table 5.2 Main results for balance, gait parameters, functional fitness, HRQL, cognition, falls efficacy and habitual physical activity at baseline and postintervention by group: control and intervention. 89 Table 6.1 Participants’ characteristics at baseline: sociodemographic, clinical, cognition, balance, functional fitness, physical activity and health-related quality of life. 104 Table 6.2 Findings on the outcome measure at baseline and after the intervention by group: control and intervention. 106 Table 6.3 Findings on the outcome measure at baseline and after the intervention by group: control and intervention. 106 Table 7.1 Participants’ characteristics at baseline: sociodemographic and clinical characteristics, cognition, balance, functional fitness, physical activity and healthrelated quality of life. 120 Table 7.2 Findings on the outcome measures at baseline and after the intervention by group. 122 Table 7.3 Findings on the outcome measures after the intervention and at follow up by group. 123 Figures Figure 1.1 Schematic of the main stages and key activities of the process of developing and evaluating complex interventions. 7 Figure 2.1 Schematic representation of the Functional Consequences Theory for 18 vi Promoting Wellness in Older Adults. Figure 5.1 Participant flow of the pilot study. 87 Figure 6.1 Participant flow through the phases of the randomized controlled trial. 103 Figure 6.2 Graphic representation of the results from the mixed between-within subjects analysis of variance (group vs time), showing the change in FAB scale total scores over time for the IG and CG. 107 Figure 7.1 Participant flow through the phases of the randomized controlled trial. 119 Figure 7.2 Graphic representation of the results from the mixed between-within subjects analysis of variance showing the change in the chair stand (a) and arm curl tests (b), over time for the CG and IG 124 Figure 7.3 Graphic representation of the results from the mixed between-within subjects analysis of variance (group vs time, with PA and age as covariates), showing the change in cadence at maximal speed, over time for the CG and IG. 125 vii Acknowledgments As I have the privilege to complete this thesis, I would like to acknowledge the contribution of several persons and institutions that made this achievement possible. First, I would like to acknowledge my supervisor, Professor Helena Jardim. Thank you for your readiness, encouragement, and wise guidance during the development of this work. To my co-advisor, Professor Manuela Martins, I would like to thank for your advice, availability, and support. I would like to acknowledge Professor Debra Rose, for coadvising me, for receiving me in your University, for sharing your expertise and valuable thoughts. Several Professors have also contributed to this process through knowledge sharing. To Professor Ingalill Ram Halberg, I’m very grateful for the opportunities to discuss my research ideas, for your availability, and wise advice. To Professor Duarte Freitas, I’m very grateful for your valuable comments, all the collaboration and support during all this process. To Professor José Maia, I’m grateful for your comments and for our enriching discussions. To Professor Corália Vicente, I would like to thank you for the challenge. To the European Academy of Nursing Sciences, its president, Professor David Richards, and all professors, members and students, thank you for the sharing! The EANS Summer School for Doctoral Studies was pure knowledge! Special thanks go to Professor Sascha Köpke, Professor Ian Norman and Professor Peter Griffiths, for the helpfulness in answering doubts along this way. Thanks to the ProBalance team! I’m very grateful for your collaboration and dedication! Thanks to Professor Rubio Gouveia, RN Bárbara Silva, RN Deolinda Fernandes, RN Celina Quintal, RN Liliana Vieira, RN Rosana Bettencourt, RN Ana Pinto, Prof. Rui Rodrigues, Prof. Letícia Sousa and Prof. Joana Castro, who took part in the Assessment Team; and to the 23 Nursing and Physical Education Students who took part in the intervention team. You made our project happen, thank you! I wish to acknowledge all older adults who were volunteers and participants in our project. You are my reason and inspiration, thank you for your collaboration and for this opportunity. I would like to acknowledge the Madeira Regional Health Service, namely Nurse Director Conceição Vieira, for the encouragement and support to me and this project since the beginning. I thank the University of Madeira, Professor Castanheira da Costa, Professor Gonçalo Gouveia and the Health Technologies Competence Centre for receiving and supporting viii my project and for the opportunity to make the ProBalance laboratory a reality. Thank you also to all the Staff, who guided the participants to the laboratory every day. Thanks to all other professors who contributed to my present knowledge and encouraged me to proceed, namely, Professor Maria Do Céu Barbieri, Professor Walter Osswald, Professor António Fonseca, Professor Sílvio Velosa, Professor Ana Natividade, Professor Luísa Santos, Professor Isabel Fragoeiro, Professor Emanuel Gouveia and Professor Teresa Ornelas. I would like to thank all institutions that colaborated in the project’s advertisement, namely, Associação de Desenvolvimento Comunitário do Funchal, Casa do Povo da Nazaré, Centro de Convívio Luís de Camões, Centro de Convívio de Santa Maria Maior, Junta de Freguesia de São Roque and Diocese do Funchal. I would like to thank ARDITI, for the funding for this research. To the American Physical Therapy Association, and Dr. Gini Blodgett Birchett, thank you for the sharing of documents. To Dr. Ana Paula Pereira, thank you for all the support during this process. To all colleagues in Centro de Saúde de Santo António, thank you for the support. To all my family and my friends, especially Claudia Abreu and Nélia Gouveia, thank you for the support, friendship and for your ability to understand me. To my parents, Guiomar Ornelas e Rogério Ornelas, thank you so much for your unconditional support, for your wise advice, for your patience and enormous love. To my husband, Rubio, I thank you for your dedication, reinforcement, inspiration and support. As you said back in 2011, “My work is your work because my life is your life!” I would like to finish with a thought about a person who unfortunately is no longer among us. My mother-in-law, Ermelinda Quintal, was the biggest example of strength that I could ever find during these years. I wish we could celebrate this achievement all together! Bruna Ornelas de Gouveia. ix Abstract Falls in community-dwelling older adults and their impact are major concerns for nurses. Balance, strength and gait impairments are known to be the strongest modifiable risk factors for falls, therefore, a focus for targeted nursing interventions. The purposes of this research were: (1) to assess the feasibility and safety of the ProBalance program; and (2) to assess the effect of the ProBalance program, on balance, strength and gait of community-dwelling older adults with balance impairments, when compared to a control group, after a 12 weeks intervention and 12 weeks follow up. The main randomized controlled trial (RCT) included a sample 177 older adults, 52 eligible participants were randomized to two similar groups (IG/CG). Assessments were at 0 (pre-test), 12 (post-test), and 24 weeks (follow up). Analysis included completers (n=46). The ProBalance program included gait, balance, functional training, strengthening and endurance, flexibility, and 3D training. The intervention was administered on a group basis by one trained rehabilitation nurse, in 90 min sessions, 2 days per week, for 12 weeks. Balance was assessed by the Fullerton Advanced Balance (FAB) scale. Strength was assessed as in the Senior Fitness Test battery and gait parameters by the 30-Foot Walk Test. A pilot study focused on the feasibility of this research (RCT, n=12). The protocols for assessments and intervention were fully applied, and no adverse events were associated to participation. Eligibility rate was low (15%) and the attrition rate was null. Reliability of all measures, assessed by intra-class correlation coefficient (R), ranged between 0.689 and 1.000. This study demonstrated beneficial effects of the ProBalance program in improving balance and reducing fall risk in the IG, immediately after the intervention. While the IG reduced fall risk by 40%, the CG experienced a fall risk increase by 11.6%. Significant effects were seen in strength; and gait velocity and cadence at maximal speed at posttest. Short-lasting effects were verified at follow-up, with significant decreases occurring in balance scores and strength tests for the IG. Overall, this research demonstrated the feasibility, safety and efficacy of the ProBalance intervention in community-dwelling older adults with balance impairments. Future research should focus on the long term-efficacy of the ProBalance intervention and include pragmatic trials to assess the effectiveness and cost-effectiveness of this intervention in “real world” clinical settings. Key words: Gerontological rehabilitation nursing, Community-dwelling older adults; Fall risk; Balance; ProBalance Program. 8 1.3 The nursing theory supporting the approach to older adults A nursing theory provides the theoretical background to this research – the “Functional consequences theory for promoting wellness in older adults” (Miller, 2012). This theory was specifically designed to provide a framework for nursing care in older adults, recognizing that, in older adults, age-related changes and risk factors combine to cause negative functional consequences, and nursing interventions are planned to counteract or minimize these negative functional consequences, thereby promoting positive functional consequences or an optimal level of function (wellness outcome). Considering the aims of the “Functional consequences theory” and its coherence with rehabilitation nursing demands, we believe that this theory is a suitable framework for the development of this approach to older adults with balance impairments. In addition to the theoretical framework, an independent concept was found relevant for this research, namely, the concept of prehabilitation. This concept has been introduced in the rehabilitation domain to describe a preventive intervention meant to enhance functionality, prior to the occurrence of an expected stressor (Spain, 1985) and it has also been suggested as an important concept in the care of older adults. In this specific area of care, it refers to interventions aimed at promoting functionality while delaying or minimizing disability (Gill et al., 2003; Gill et al., 2004; Carli & Zavorsky, 2005; Halberg, Cornélissen & Beaty, 2008), which is also supportive of our approach to older adults in regard to falls as negative event. 1.4 Aims and hypothesis From a rehabilitation nursing perspective, specifically in view of the “Functional consequences theory for promoting wellness in older adults” (Miller, 2012), and considering the potential effects of prehabilitation exercise interventions on balance control, designing and testing a targeted balance intervention is the main topic of this research. The purpose of this research project are: (1) to assess the feasibility and safety of the ProBalance program (a rehabilitation nursing intervention) in community-dwelling older adults from Madeira, Portugal; and (2) to assess the effect of the ProBalance program in a group of community-dwelling older adults from Madeira, Portugal, on balance, muscular strength and gait parameters, when compared to a control group after a 12 weeks duration intervention and 12 weeks follow up. In addition to these objectives, three research hypotheses were formulated to guide interpretation and conclusions to be drawn from the future results of this research: (1) The group of community-dwelling older adults involved in the ProBalance program will have significantly higher levels of balance and lower risk for falling when 9 compared with the group that did not receive the ProBalance intervention, after a 12 week duration intervention and 12 week follow up (H1); (2) The group of community-dwelling older adults involved in the ProBalance program will have higher levels of muscular strength (lower body and upper body) when compared with the group that did not receive the ProBalance intervention, after a 12 week duration intervention and 12 week follow up (H2); (3) The group of community-dwelling older adults involved in the ProBalance program will have better results in gait parameters when compared with the group who did not receive the ProBalance intervention, after a 12 week duration intervention and 12 week follow up (H3). 1.5 Operational definition of central concepts To ensure consensus when analyzing and interpreting the information on this research report, we present the operational definition of the central concepts in this investigation. Gerontological rehabilitation nursing Gerontological rehabilitation nursing is a field of nursing practice that focuses on the specific necessities of rehabilitation clients in old age, specifically, targeting age-related changes and functional limitations associated with injuries or illness. The goal of gerontological rehabilitation nursing is to assist older adults to achieve an optimal wellbeing, prevent complications, and enhance their quality of life (Easton, 1999; Mauk, 2006). Community-dwelling older adults In the context of this research, the community-dwelling older adult is an adult aged 65 and over (Jones & Rose, 2005), who lives in the community and is able to walk without any assistance. Fall risk Fall risk is an increased vulnerability to falls, derived from the presence of biological, behavioral, socioeconomic and environmental factors that increase the likeliho od of falling (Miller, 2011; WHO, 2007). These risk factors are often described as predisposing or precipitating factors for falls. Balance, strength and gait impairments are considered predisposing factors, while home hazards and type of glasses worn are viewed as precipitating factors (Tinetti & Kumar, 2010). However, the majority of falls result from the interaction between predisposing and precipitating factors (Rubenstein, 2006). 10 Balance Balance relates to the ability to maintain equilibrium, even when you are exposed to an unstable condition, so that the position of the center of mass can move vertically or horizontally within the base of support, without the person falling (Chapman, 2008). It is a complex skill that involves the detection and integration of sensory information and the execution of appropriate motor responses to control body position that are specific to the environmental and task demands (Rose, 2010; Winter, Patla, & Frank, 1990). ProBalance program The ProBalance program is an exercise intervention designed to improve balance of community-dwelling older adults with balance impairments. It is inspired by the FallProof Balance and Mobility Program (Rose, 2010), and as in this program, it is a theory-driven intervention, adopting a multidimensional approach to balance and mobility, targeting important intrinsic risk factors associated with increased fall risk, such as impaired balance and gait, and muscle weakness (Rose, 2011). 1.6 Outline of the thesis The present research project - Prehabilitation and Rehabilitation Nursing: Balance/ fall risk in the community-dwelling older adults - Randomized Controlled Trial – will be reported in this thesis, throughout eight chapters. After this general introduction (chapter one), chapter two will describe in a concise way the theoretical and scientific background to this research. The first topic addressed in this section is the conceptual model that supports our nursing approach to older adults with balance impairments. The “Functional consequences theory for promoting wellness in older adults” and the concept of “Prehabilitation” are presented and discussed as basis for nursing planning. The next topic is falls in community-dwelling older adults, followed by discussion on balance in this population and lastly the rationale for the ProBalance intervention. Chapter three (Method) will report the methodological options in the present research. Definitions of study type, investigation question, sample and participants, recruitment and enrolment, intervention and control, outcome and interfering variables, instruments and assessment, ethical considerations, and quality control are specified. Chapters four, five, six and seven are original articles elaborated in the context of this research, which describe all the findings of this research. Chapter four includes a theoretical article: Therapeutic exercise in Gerontological Rehabilitation: A literature analysis. Chapter five is composed by an article focused on the pilot study. This article is 11 entitled: The ProBalance Program for improving balance in older adults: A pilot study. Chapter six comprises the first article focused on the main RCT, namely in assessing the effect of the ProBalance intervention on our primary outcome (balance). The article is entitled: The ProBalance Program improves balance and reduces fall risk in communitydwelling older adults from Madeira Island, Portugal: A randomized controlled trial. The last article included in this thesis consists on chapter seven: The effect of the ProBalance Program in strength and gait of community-dwelling older adults from Madeira Island, Portugal: A randomized controlled trial. In this article, the effect of the intervention on the secondary outcome (strength and gait) is assessed. The last chapter in the thesis is Chapter eight, describing the general conclusion of this research. In this section we give an overview of the study findings and address the limitations and strengths of the study design, as well as, the implications for clinical practice and future directions. References are presented at the end of each chapter and the information included in the original research articles is in line with the CONSORT Statement guidelines for reporting clinical trials (Boutron et al., 2008). 1.7 References American Geriatrics Society, British Geriatrics Society, & American Academy of Orthopaedic Surgeons Panel on Falls Prevention (2001). Guideline for the prevention of falls in older persons. Journal of the American Geriatric Society, 49(5), 664–672. Balzer, K., Bremer, M., Schramm, S., Lühmann, D., & Raspe, H. (2009). Falls prevention for the elderly. GMS Health Technology Assessment, 8. Boutron, I., Moher, D., Altman, D.G., Schulz, K.F., Ravaud, P. & CONSORT Group. (2008). Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Annals of Internal Medicine, 148(4), 295-309. Carli, F., & Zavorsky, G.S. (2005). Optimizing functional exercise capacity in the elderly surgical population, Current Opinion in Clinical Nutrition and Metabolic Care, 8(1), 23-32. Chapman, A.E. (2008). Biomechanical analysis of fundamental human movements. Champaign, IL: Human Kinetics 12 Costello, E. & Edelstein, J.E. (2008). Update on falls prevention for community-dwelling older adults: review of single and multifactorial intervention programs. Journal of Rehabilitation Research and Development, 45(8), 1135-1152. Deandrea, S., Lucenteforte, E., Bravi, F., Foschi, R., La Vecchia, C., Negri, E. (2010). Risk Factors for Falls in Community-dwelling Older People: A Systematic Review and Meta-analysis. Epidemiology, 21(5), 658-668. Easton, K.L. (1999). Gerontological rehabilitation nursing. Philadelphia: Saunders. EuroSafe. (2013). Injuries in the European Union, Report on injury statistics 2008-2010, Amsterdam: EuroSafe. Gill, T.M., Baker, D.I., Gottschalk, M., Gahbauer, E.A., Charpentier, P.A., de Regt, P.T., & Wallace, S.J. (2003). A prehabilitation program for physical frail community-living older persons. Archives of Physical Medicine and Rehabilitation, 84, 394-404. Gill, T.M., Baker, D.I., Gottschalk, M., Peduzzi, P.N., Allore, H., & Ness, P. (2004). A prehabilitation program for the prevention of functional decline: effect on higherlevel physical function. Archives of Physical Medicine and Rehabilitation, 85, 1043- 1049. Gillespie, L.D., Robertson, M.C., Gillespie, W.J., Sherrington, C., Gates, S., Clemson, L.M., Lamb, S.E. (2012). Interventions for preventing falls in older people living in the community. Cochrane Database of Systematic Reviews, 9, Art. No.: CD007146. Gouveia, E.R. (2011). Health in Madeira: a comprehensive study of aging, body composition, physical activity and functional fitness (Doctoral dissertation). University of Madeira, Funchal. Halberg, F., Cornélissen, G., & Beaty, L.A. (2008). Prehabilitation by women to save the cost of rehabilitation by detecting and treating a premetabolic syndrome. International Journal of Gerontology-Chronome-Geriatrics, 11(14), 159-183. Halberg, I.R. (2006). Challenges for future nursing research: Providing evidence for health-care practice. International Journal of Nursing Studies, 43, 923-927. Halberg, I.R. (2009). Moving nursing research forward towards a stronger impact on health care practice?. International Journal of Nursing Studies, 46, 407-412. Howe, T.E., Rochester, L., Neil, F., Skelton, D. A. & Ballinger, C. (2011). Exercise for improving balance in older people. Cochrane Database of Systematic Reviews, 11, Art. No.: CD004963. 13 NHORJ [National Health Observatory Ricardo Jorge]. (2011). Adelia. Acidentes Domésticos e de Lazer: Informação Adequada. Relatório 2006-2008. Lisboa: NHORJ. Jones, G. J. & Rose, D. J. (2005). The field of gerokinesiology. In Jones G. J. & Rose, D. J. (Eds.), Physical activity instruction of older adults (pp.11-21). Leeds: Human Kinetics. Kannus, P., Sievänen, H., Palvanen, M., Järvinen, T., & Parkkari, J. (2005). Prevention of falls and consequent injuries in elderly people. Lancet, 366, 1885–1893. Mauk, K.L. (2006). Introduction to gerontological nursing, In Mauk KL (Ed.), Introduction to gerontological nursing: Competences for care (pp. 5-28). London: Jones and Bartlett. Miller, C.A. (2012). Nursing for wellness in older adults (6th Ed.). Philadelphia: Lippincott Williams & Wilkins. MRC [Medical Research Council]. (2008). Developing and evaluating complex interventions: new guidance. London: Medical Research Council. Rose, D.J. (2008). Preventing falls among older adults: No "one size suits all" intervention strategy. Journal of Rehabilitation Research & Development, 45(8). 1153-1166. Rose, D.J. (2010). FallProof! A comprehensive balance and mobility training program (2nd Ed.). Champaign: Human Kinetics. Rose, D.J. (2011). Reducing the Risk of Falls Among Older Adults: The Fallproof Balance and Mobility Program. Current Sports Medicine Reports, 10(3), 151-156. Rubenstein, L.Z. & Josephson, K.R. (2002). The epidemiology of falls and syncope. Clinical Geriatric Medicine, 18, 141–158. Rubenstein, L.Z. (2006). Falls in older people: epidemiology, risk factors and strategies for prevention. Age Ageing, 35(Suppl 2), ii37-ii41. Sherrington, C., Whitney, J.C., Lord, S.R., Herbert, R.D., Cumming, R.G., & Close, J.C.T. (2008). Effective exercise for the prevention of falls: A systematic review and metaanalysis. Journal of the American Geriatrics Society, 56, 2234–2243. Sherrington, C., Whitney, J.C., Lord, S.R., Herbert, R.D., Cumming, R.G., & Close, J.C.T. (2008). Effective Exercise for the Prevention of Falls: A Systematic Review and Meta-Analysis. Journal of the American Geriatrics Society, 56(12), 2234–2243. Spain, J. (1985). Prehabilitation. Clinical Sports Medicine, 4(3), 575-585. 14 Statistics Portugal (2012a). Censos 2011 resultados definitivos – Portugal. Lisboa: Statistics Portugal. Statistics Portugal (2012b). Censos 2011 resultados definitivos – Região Autónoma da Madeira. Lisboa: Statistics Portugal. Sturnieks, D.L., St George, L., & Lord, S.R. (2008). Balance disorders in the elderly. Clinical Neurophysiology, 38(6), 467-478. Tinetti, M.E. & Kumar, C. (2010). The patient who falls “It’s always a trade-off”. Journal of the American Medical Association, 303(3), 258-266. WHO [World Health Organization] (2013). The European health report 2012: Charting the way to well-being. Copenhagen: WHO Regional Office for Europe. WHO [World Health Organization]. (2007). Global report on fall prevention in older age. Geneva: WHO. Winter, D.A., Patla, A.E. & Frank, J.S. (1990). Assessment of balance control in humans. Medical Progress through technology, 16, 31-51. 15 Chapter 2 Theoretical and scientific background: State of art 2.1 The Functional consequences theory for promoting wellness in older adults and the concept of Prehabilitation 2.2 Falls in community-dwelling older adults 2.3 Balance in older adults 2.4 The ProBalance intervention 2.5 References Bridge In this chapter, we approach the theoretical and scientific background to our research project, starting with a description of our nursing perspective in the care of older adults. Following an overview of the current knowledge about falls, balance in older adults will be addressed as the central topic of this research. Information of the systems that contribute to balance as well as the age-related changes that affect balance are discussed in this section. Finally, we review the most relevant literature regarding balance assessment and interventions aimed at improving the balance of older adults, discussing the rationale for the ProBalance intervention, which will be tested in the context of this research. 16 2.1 The Functional consequences theory for promoting wellness in older adults and the concept of Prehabilitation Gerontological rehabilitation nursing is a specific nursing practice that focuses on the distinctive necessities of elderly rehabilitation clients, namely, age-related changes and functional limitations associated with injuries or illness. The goal of gerontological rehabilitation nursing is to assist older adults achieve an optimal physical, mental, and psychosocial well-being, prevent complications, and enhance their quality of life (Easton, 1999; Mauk, 2006). Rehabilitation itself is a complex process that demands a multidisciplinary and theoretically-based approach to care (Lutz & Davis, 2008). Nevertheless, this discussion will focus on models that guide practice in rehabilitation nursing, especially in the gerontological area. Based on specific knowledge from other disciplines, rehabilitation nursing practice inherits a theoretical background from biological, psychological, sociological, and anthropological theories that focus on life processes, well-being, and optimal function. Derived from these basic disciplines, many nursing theories have been developed and considered relevant to rehabilitation nursing practice. Examples include Roy’s adaptation model, Roger’s model of the science of unitary human beings, King’s general systems framework and theory of goal attainment, Neuman’s systems theory, the Omaha system, Roper’s model for living, Gordon’s functional health patterns, Virginia Henderson’s humanistic theory, Hall’s philosophy of nursing, and Orem’s theories related to self-care (Easton, 1999; Lutz & Davis, 2008). In addition to our discussion of these theoretical perspectives, we wish to draw attention to a theory developed during the nineties and recently updated by a gerontological clinical nurse specialist, Carol Miller (Miller, 1990; 2012). The “Functional consequences theory for promoting wellness in older adults” is a theoretical approach that addresses the nurse’s role in enhancing health, functioning, and quality of life in older adults. This wellness approach draws on multidisciplinary knowledge on aging and from the conceptualizations of many nursing theorists, namely, Florence Nightingale, Virginia Henderson, Imogene King, Jean Watson, Martha Rogers, Margaret Newman, Calista Roy, Rosemarie Parse, and Madeleine Leininger. Central to the theory is Dunn’s definition of wellness. Wellness is not a simple condition (opposite to sickness), “but rather a complex state made up of overlapping levels of wellness”, associated with a person, who is a physical, mental, and spiritual unit (Dunn, 1959, p.786). Miller (2012) introduces innovative concepts such as functional consequences, agerelated changes, and risk factors, and describes a comprehensive conception of the person, nursing, health, and the environment. Functional consequences are described as observable effects of actions, age-related changes, and risk factors that influence quality 17 of life and the older adult’s performance of activities of daily living. These consequences can be negative if they interfere negatively with the person’s level of functioning and quality of life. On the other hand, the consequences can be positive, if they facilitate the attainment of an optimal level of performance (i.e., the highest level of functioning and lowest dependency possible). When positive functional consequences are the result of nursing interventions, they are called wellness outcomes. Age-related changes are described as irreversible, inevitable, and progressive changes occurring in olderadulthood, independently of external and pathological conditions. While on a physiological level, these changes are normally degenerative, on psychological and spiritual levels, they comprise potential for growth. Risk factors are, in contrast, conditions that enhance the older adult’s vulnerability to negative functional consequences, such as diseases, unhealthy lifestyle and negative attitudes towards care. A person is defined as an older adult whose functional performance is affected by age-related changes and risk factors. When older adults are dependent on others for daily needs, their caregivers are also considered an integral focus of nursing care. As for the concept of nursing, the author states that nursing aims to minimize the negative effects of age-related changes and risk factors, and thereby promote wellness outcomes. Health is defined as the ability of older adults to achieve their highest level of functional performance (in terms of spiritual, psychosocial, physiological functions) and quality of life, despite age-related changes and risk factors. Also, it encompasses well-being and quality of life as defined by each older adult. Lastly, the concept of environment is defined as the external conditions, including caregivers. It can be considered a risk factor if it interferes negatively with function, or an intervention if it leads to improved function. Six premises support this model: (1) holistic nursing care address the body–mind–spirit interconnectedness of each older adult and wellness incorporates more than physiological functioning; (2) although age-related changes are inevitable, most problems affecting older adults are associated with risk factors; (3) older adults experience positive or negative functional consequences as a result of the combination of age-related changes and additional risk factors; (4) nursing interventions intend to alleviate or modify the negative functional consequences of risk factors; (5) nurses can promote wellness in older adults through health promotion and other nursing interventions that address the negative functional consequences; (6) nursing interventions result in positive functional consequences, also called wellness outcomes, that enable older adults to function at their highest level despite the presence of age-related changes and risk factors (Miller, 2012). At a practical level, the “Functional consequences theory” provides a framework for promoting wellness in older adults. Nurses assess the age-related changes, risk factors, and derived functional consequences, aiming to identify the factors that can be addressed 24 Behavioral risk factors Behavioral risk factors for falls include multiple medication use, low levels of physical activity, inappropriate diet, excessive alcohol intake, inadequate footwear, and other riskassociated behaviors (WHO, 2007). Medication use is often discussed in the literature, since it is one of the most easily modifiable risk factors for falls. Not only are the pharmacological properties and side effects of certain drugs important to understand, but also the age-related changes in pharmacokinetics that can impact postural stability, and therefore increase the risk for falls (Lord, Sherrington, Menz, & Close, 2007; Rubenstein & Josephson, 2002). Fall-risk increasing medications include drugs prescribed for cardiovascular diseases such as digoxin, anti-arrhythmics, and diuretics, benzodiazepines, antidepressants, antiepileptics, antipsychotics, antiparkinsonian drugs, opioids and urological spasmolytics. However, psychotropic and benzodiazepine use are the most consistently associated with falls (Hill & Wee, 2012; Huang et al., 2012), even when taking into account underyling disease (Lord, Sherrington, Menz, & Close, 2007). Independently of the type of medication, polymedication (described as the use of four or more medications) is also associated with increased fall risk (Lord, Sherrington, Menz & Close, 2007; Rose, 2010; Tinetti & Kumar, 2010; Tinetti, Speechley, & Ginter, 2008). Also, the use of inappropriate footwear is a behavioral factor associated with the occurrence of slips and trips. Examples of poor footwear include shoes with high heels or slippery soles (Lord, Sherrington, Menz, and Close; 2007). Physical inactivity is also a behavioral factor that affects mobility and balance in older adults, therefore, increasing fall risk. Regular physical activity, combined with an appropriate diet, is also important for global health and wellbeing (Rose, 2010). Alcohol intake has been identified as a risk factor for falls by Tinetti & Kumar (2010), based on expert opinion and clinical experience. Alcohol may have an adverse impact on perception and cognition, and an association with risk-taking behaviors. Another behavioral risk factor is fear of falling. Inappropriate fear of falling includes being fearless or being fearful. These two situations seem to be relevant when discussing falls in older adults. Delbaere et al. (2006) have studied the relationship between these situations and falls. Their results showed that older adults with an inappropriate low fear of falling were physically strong, but had poor balance. The lack of awareness of their risk for falls enhanced their exposure to dangerous situations. On the other hand, those with an inappropriate high fear of falling had low muscle strength and restricted activities. However, fear of falling can arise prior to a fall and/or as a result of a fall. Lee, Mackenzie, and James (2008) state, however, that the experience of falls directly influences the fear. These authors found that most participants in their study did not fear falling until they had experienced a fall themselves (faller status). Rubenstein and Josephson (2002) also recognize fear of falling as a 25 negative consequence of falls, and also suggest that loss of confidence in the ability to move safely can cause further functional decline, depression, feelings of helplessness, and social isolation. Socioeconomic risk factors Although socioeconomic factors are not directly related to the risk of falls, low income and educational levels, the lack of social interactions and limited access to health and social care or services can affect the older adults’ health condition and therefore increase their risk for falls (Rose, 2010). For example, older adults who live alone are more likely to use an ambulatory device and have safety equipment, and also experience more falls (Elliott, Painter, & Hudson, 2009). Environmental risk factors Several environmental factors have been suggested to be related to falls in older people, namely, slippery or uneven floor surfaces, loose rugs and upended carpet edges, obstructed walkways, and poor building design, including raised door sills, inadequate stairs, and lack of handrails (Lord, Sherrington, Menz, & Close, 2007). Lord et al. (2007) suggest, however, that the existence of environmental risk factors for falls is not sufficient to cause falls. Rather, the interaction between the older adult’s physical function, the perception of risk, and the exposure to the risk seems to be more important. Relative importance of risk factors for falls In the last decades, many investigators have conducted epidemiological studies to identify specific factors and their relative importance in increasing the likelihood of falling. In face of the large number of studies addressing this issue, some systematic reviews of literature were conducted and consistent conclusions advanced (Rubenstein & Josephson, 2002; Tinetti & Kumar, 2010; Deandrea et al., 2010). For example, Rubenstein and Josephson (2002) reported the results from a univariate analysis of multiple risk factors from 16 studies conducted in both community and nursing home environments. The authors identified 11 risk factors for falls as well as the relative risk (from prospective studies) or odds ratio (from retrospective studies) associated with each risk factor. Results from this review showed that the major risk factor for falls was muscle weakness, which was responsible for increasing the odds of falling over 4-fold on average (1.5–10.3). Having a history of falls, gait impairments, and balance deficits were also found to be significant risk factors in many studies, being associated with an approximately 3-fold increased risk of falling (RR/OR ranging from 1.7–7.0, 1.3–5.6, 1.6–5.4, respectively). Using an assistive device, having visual deficits and arthritis were associated with an approximately 2.5-fold 26 increased risk of falling (1.2–4.6, 1.6–3.5, 1.9–2.9, respectively). Impaired ability to perform basic activities of daily living, depression, cognitive impairment, and age over 80 years were associated to a 2-fold increased risk of falling (1.5–3.1, 1.7–2.5, 1.0–2.3, 1.1– 2.5). Since 11 of the studies included in this review used a multivariate analysis, accounting for the interaction between factors was important. The authors found, however, that the risk factors emerging from these analysis were similar to those identified in the univariate analysis, with slightly different sizes of risk for some of them. In the multivariate analysis, muscle weakness still remained the main risk factor with a 4-fold increased risk of falls. Balance deficits, a history of falls, cognitive impairment, age over 80 years, and visual impairments were associated with a 3-fold increased risk of falls, while gait impairments were associated with an approximately 2-fold increased risk of falls. Tinetti and Kumar (2010) conducted a systematic review to identify multiple impairments and conditions predisposing community-dwelling older adults to falls. Of the 33 studies included, 17 risk factors were identified. Among the identified conditions, the strongest risk factors for falling, based on relative risk ratios (RR) were a history of falls (1.9-6.6), muscle weakness (2.2-2.6), balance deficits (1.2-2.4), gait impairments (1.2-2.2), and use of specific medications (1.1-2.4). Other common risk factors also included depression (1.5- 2.8), dizziness or orthostasis (2.0), functional limitations and disability related to the performance of basic activities of daily living (1.5-6.2) and age over 80 years (1.1-1.3). Other risk factors only found in a small number of studies (two to three), were also identified by the authors. These included female gender (RR 2.1-3.9), low body mass index (RR 1.5-1.8), urinary incontinence (OR 1.3-1.8), cognitive impairment (RR 2.8), arthritis (RR 1.2-1.9), diabetes (RR 3.8); and pain (OR 1.7). Similar results were described in a systematic review conducted by Deandrea et al. (2010). These authors analyzed a total of 74 studies and identified 31 risk factors, in older adults with a history of falls (single fall and reccurent falls). Results from this review showed that the factors most strongly associated with falls were a history of falls (OR 2.8 for all fallers; 3.5 for recurrent fallers), gait impairments (2.1; 2.2), use of walking aids (2.2; 3.1), vertigo (1.8; 2.3), Parkinson’s disease (2.7; 2.8), and use of antiepileptic drugs (1.9; 2.7). Unfortunately, the authors did not present odds ratios for balance deficits and muscle weakness, due to the heterogeneity of the measures used in various studies. Further evidence suggests that muscle weakness, balance and gait impairments, and the use of specific medications are the strongest modifiable risk factors for falls (Rubenstein & Josephson, 2002; Tinetti & Kumar, 2010; Deandrea et al., 2010). In addition to discussing the relative importance of different types of risk factors for falls, the number of risk factors has also been shown to be important. In one study, the 1-year 27 risk of falling increased linearly with the number of risk factors, ranging from 8% with none, to 78% with four or more risk factors (Tinetti, Speechley, & Ginter, 1988). Also, in a prospective study conducted by Muir et al. (2010a), when considering the impact of all risk factors together, fall risk doubled (RR 2.0; 1.13–3.56) per unit increase in the number of risk factors (e.g., lower-extremity muscle weakness, balance impairment, and four or more prescription medications). In the same study, the authors reported that lower-extremity weakness, balance impairment, and the number of risk factors were independent predictors of the transition in status from non-faller to faller. These results suggest the importance of the risk assessment and intervention targeting strength and balance also in older adults who have not yet fallen. 2.3. Balance in older adults As previously discussed, falls in older adults are multifactorial in nature and impaired balance is one of the major factors associated with a higher risk of falling. From a rehabilitation nursing perspective, specifically in view of the “Functional consequences theory” (Miller, 2012), and considering the potential effects of prehabilitation exercise interventions on balance control, designing and implementing an effective balance intervention is the main topic of this research. Balance In the past decades, the scientific evidence of degeneration in balance control accompanying aging has led researchers and clinicians to look for a complete understanding of how balance control works (Winter, 1995). In 1989, Nashner suggested that human balance is maintained through a complex process involving sensory detection of body motions, integration of sensorimotor information within the central nervous system and execution of appropriate musculoskeletal responses (p.5). Besides this definition gathers agreement, many other definitions and concepts have been used when discussing balance. The term equilibrium is used to describe a body at rest - static equilibrium, or in stable motion - dynamic equilibrium (Kloos & Givens, 2012). Static equilibrium requires that the center of mass of the system be located vertically above the base of support, with zero velocity and all forces in all directions summing to zero (Chapman, 2008; Oatis, 2009). Yet, when considering human balancing, the requirement for static equilibrium is hardly applicable, due to the existence of the multi-segments of the body and the various forces acting upon them. The closest approximation to perfect static equilibrium is achieved by making small adjustments in joint positions in order to maintain a zero velocity. 28 Consequently, the position of the center of mass can move vertically or horizontally within the base of support, without the person falling (Chapman, 2008). Though some authors refer to balance and postural stability as synonyms (Kloos & Givens, 2012), it has been argued that they do not refer exactly to the same concept (Haywood & Getchell, 2009). This position is supported by the idea that stability implies resistance to movement, while balance relates to the ability to maintain equilibrium, even when you are exposed to an unstable condition. Limits of stability (LOS) is the term used to describe the distance that a person is able or willing to lean in a specific direction, without altering the base of support. While these limits vary according to the biomechanical characteristics of the individual, the type of task and environmental constraints, it has been demonstrated that an adult can sway approximately 12 degrees in the backward-forward direction and 16 degrees laterally without moving the feet (Nashner, 1989). Individuals maintain or restore their postural control either consciously (i.e., anticipatory postural control) or subconsciously (i.e., reactive postural control) (Rose, 2010; Woollacott & Shumway-Cook, 1996). Anticipatory postural control can also be referred to as proactive postural control. It consists of the ability to activate postural adjustments in anticipation of potentially disruptive situations in order to minimize dislocation of the center of mass from its desired position (Woollacott & Shumway-Cook, 1996). It includes planned actions, such as obstacle avoidance or negotiation (Rose, 2010). On the other hand, reactive postural control involves automatic responses to unexpected situations. These types of actions are executed when the sensory system identifies movement of the center of mass away from a stable position. In this situation, a muscle response is activated to rapidly restore the center of mass to a position of stability (Woollacott & Shumway-Cook, 1996). Main motor strategies for postural control In the past, disrupting stable equilibrium and observing the subsequent behavioral reactions has been a useful experimental approach for understanding the mechanisms of postural control (Horak, Henry, & Shumway-Cook, 1997). Horak and Nashner (1986) described three major postural strategies observed: (1) the ankle strategy; (2) the hip strategy; and (3) the step strategy. However, a variety of complex body movement trajectories can be generated by combining pure ankle and hip strategies, as acknowledged by these authors. In Horak and Nashner’s experiment, when the participants were exposed to brief forward or backward horizontal surface perturbations in a standing position, a compensatory pattern of muscle activity was initiated within the ankle joint muscles. This level of muscle activity was sufficient to restore the individual’s 29 equilibrium. The authors termed this strategy the ankle strategy (Horak & Nashner, 1986). The ankle strategy can only be used to consciously control body sway in the standing position through a very small range on motion because the ankle joint muscles can only generate a relatively small amount of force. At a subconscious level, this strategy can also be used to restore balance following a small but unexpected perturbation. To be effective, this strategy demands an adequate range of motion and strength of the ankles, a firm and broad surface beneath the feet, and an adequate amount of sensory reception in the feet and ankles (Rose, 2010). When facing a larger challenge, such as maintaining balance while standing on a surface that is narrower than the length of the feet, the leg and trunk muscles become active. This level of muscle activation, is referred to as the hip strategy (Horak & Nashner, 1986). In this strategy, the upper body moves in a direction that is opposite to the lower body to control postural sway as the larger hip muscles are activated. The effectiveness of this strategy is therefore dependent on an adequate range of motion and strength in the hip region (Rose, 2010). Finally, if the center of mass is displaced beyond the limits of stability, one or more steps are needed to reestablish equilibrium. A new base of support must be established in this situation. This strategy is called the step or stepping strategy (Horak & Nashner, 1986). To be effective, the step strategy requires adequate lower muscle strength and power, range of motion, and adequate central processing speed (Rose, 2010). The systems involved in balance control Balance is a complex skill that involves the detection and integration of sensory information and the execution of appropriate motor and musculoskeletal responses to control body position that are specific to the environmental and task demands. This control mechanism demands the interaction of: (1) the sensory systems, (2) the motor system, and (3) the cognitive system (Rose, 2010; Winter, Patla, & Frank, 1990). The peripheral and central components of the sensory systems Three major sensory systems are involved in balance and postural control. They include the (1) visual; (2) vestibular; and (3) somatosensory systems (Horak, 2006; Kloos & Givens, 2012; Nashner, Black & Wall, 1982; Rose, 2010; Winter, 1995). It is the combination of the information received by the peripheral receptors of these three systems that will integrated by the central components of the sensory systems, and then allow the perception of one’s body position and movement in space. Vision is the system primarily involved in planning movement and negotiating or avoiding obstacles (Winter, 1995). This system provides information about the surrounding 30 environment and our spatial location (Rose, 2010), and is derived from linear and angular motions of the visual field (Nashner, Black, & Wall, 1982). For example, the visual system can be used to promote postural stability, when the proprioceptive and vestibular inputs are unreliable, by fixating the gaze on a visual target (Kloos & Givens, 2012). The somatosensory system is comprised of proprioceptive, joint, and cutaneous receptors (Kloos & Givens, 2012) that sense the position and velocity of the body segments, their contact with external objects and support surface, and the orientation of gravity (Nashner, Black & Wall, 1982; Winter, 1995). In contrast to the visual system, the somatosensory system provides information about spatial location and movement of the body in relation to the support surface and also about the relative position of body segments. In the absence of visual input, for example in dark environments, the somatosensory system is our primary source of sensory information to maintain balance (Rose, 2010). The vestibular system is a balance mechanism located in the inner ear, which is activated when the head is moved (Rose, 2010). It senses sway-related linear and angular accelerations of the head, giving indications about the head’s position and movement, in relation to gravitational and inertial forces (Nashner, Black & Wall, 1982; Winter, 1995). Pathways from the vestibular nuclei connect with motor pathways for postural control and coordination of eye and head movements. For example, the vestibulospinal reflex allows postural changes in response to body tilt and the vestibulo-ocular reflex stabilizes vision when the head is moving (Kloos & Givens, 2012). For balance control, the central component of the sensory systems integrates the information received by the sensory systems, determines the body’s spatial orientation (Horak, Henry, & Shumway-Cook, 1997; Rose, 2010). Sensory organization allows the achievement of the two main goals of balance control: postural orientation and postural equilibrium. Postural orientation involves the active control of body alignment and tone with respect to gravity, support surface, visual environment and internal references, in response to the spatial orientation, which is based on the interpretation of the sensory information from somatosensory, vestibular and visual systems. Postural equilibrium, for instances, involves the coordination of sensorimotor strategies to stabilize the center of mass facing disturbances in postural stability (Horak, 2006). The peripheral and central components of the motor system The motor system has a major role to play in balance control through postural alignment and movement. Particularly, joint range of motion, joint integrity and muscle performance (strength, power and endurance) are important conditions to allow flexibility (Kloos & Givens, 2012). 31 For balance control, the central component of the motor system receives information from the central component of the sensory systems on the body’s spatial orientation and generates the information for action to be executed by the motor system (Horak, Henry, & Shumway-Cook, 1997; Rose, 2010). The cognitive system Attention, memory and intelligence are important abilities that allow the individual to maintain balance. In connection to both the sensory and the motor systems, the cognitive system allows processing coordinated and accurate movements. Any impairment in cognition or lack of attention will compromise the ability to perceive the environmental demands and select the type of response needed (Rose, 2010). This demand for attention is easily seen when performing dual-task. When performing two tasks at a time, the individual has to divide attention and adapt his physical performance. Age-related changes in the systems that contribute to balance Research has shown that balance declines with aging. The greatest deterioration in balance and mobility occurs from 60 and 70 years onwards (Daly et al., 2013). Agerelated changes, as described earlier when we introduced the “Functional consequences theory” (Miller, 2012), are inevitable, progressive, and irreversible changes that occur during late adulthood, affecting all body systems, including the systems that contribute to balance. Therefore, the following discussion will address the age-related changes occurring in the peripheral and central components of the sensory and motor system. In general, balance is affected when either the sensory systems, the cognitive system, or motor system is not working correctly or interaction among the systems is compromised (Browne & O’Hare, 2001). To the interaction of these systems, Kloos and Givens (2012) add the influence of contextual effects. These include the environment, which can be closed and predictable or open and unpredictable; the support surface, which can be firm or slippery, stable or unstable; the amount of light; the effects of gravity and inertia on the body; and the task characteristics, if it is a well learned or new task, planned or unplanned, single or multiple tasks. Age-related changes in the sensory system When sensory inputs contributing to balance control are reduced, older adults experience greater difficulty in maintaining balance (Woollacott & Shumway-Cook, 1990). 32 Structural changes in the eye, impaired proprioceptive function in eye muscles and poor retinal focusing are common age-related changes in the vision system (Shephard, 1997). Common effects of these changes include diminished visual acuity, depth perception and contrast sensitivity, and peripheral reduction in the visual field (Rose, 2010). Increased difficulty in judging distances, perceiving spatial relationships, and detecting low contrast hazards have a negative effect on maintaining balance and have been independently associated to falls (Lord, 2006). This overall degeneration in the visual system decreases or distorts information from the environment, which can be confusing or maladaptive for the older adult (Spirduso, Francis & McRae, 2005). Although not caused by aging, but prevalent in a large percentage of older adults, certain diseases can intensify vision impairment. Very common eye diseases include cataracts, macular degeneration, and glaucoma that significantly compromise the quality of visual input (Miller, 2012). The wearing of multifocal glasses has also been shown to aggravate the effect of age-related changes. Specifically, near-vision lenses decrease depth perception, increasing the neglect of environmental hazards and therefore causing loss of balance and falls (Lord, 2006). Age-related changes in the somatosensory system, particularly impaired proprioception, mainly in the lower limbs, have been associated with balance dysfunction in older adults. A diverse and non-uniform decline in sensory structures and function occurs with aging. Among these changes, there is a preferential loss in the anatomical structure and function of large myelinated fibers and associated receptors. This decrease is associated with impaired proprioception and/or vibration thresholds, and discriminative touch impairments (Shaffer & Harrison, 2007). Research has also shown that in older adults with increased instability, low proprioceptive control is associated with the deactivation of compensatory sensory and motor actions (e.g., visual stabilization, reactive postural control strategies) that adversely affect balance (Riva et al., 2013). Gradual age-related changes in the vestibular system such as otoconial degeneration and loss of hair cells, also lead to increased sway and can be a potential cause of presbyvertigo. Studies have demonstrated that changes in shape and number of otoconia in the utricule and saccule (reduction) happen with increasing age. Additionally, agerelated decreases in the number and density of hair cells, and increases in lipofuscin and other deformities in the cilia have been observed in human vestibular sensory and supporting cells (Walther & Westhofen, 2007). The degeneration of nerve fibers, accompanies the decrease in the number of peripheral receptors and in their sensitivity to neurotransmitters (Shepard, 1997), which constitute the peripheral nervous system, and interfere with the quantity and quality of the information available to the central nervous system. Setti, Burke, Kenny and Newell 33 (2011) suggest that, since older adults rely more on multisensory processing for robust perception, the limits of the spatial and temporal window of integration become less fixed. As a consequence, irrelevant information can be integrated, leading to inefficient perception. Age-related changes the motor system In regard to skeletal muscle, atrophy appears to be inevitable with aging. A gradual loss of muscle fibres begins at approximately 50 years of age. By the age of 80, approximately 50% of the fibres are lost from the limb muscles (Faulkner, Larkin, Claflin & Brooks, 2007). Also, prospective research in older adults has demonstrated a consistent pattern of loss in grip strength from the age of 50 years (Daly et al., 2013), providing further evidence that the decline in muscle strength with aging accompanies the reduction in muscle mass (sarcopenia) (Spirduso, Francis & McRae, 2005). Associated with structural changes, older adults also exhibit lower muscle power than young adults. Joint function is also affected by age (Hsu, Chou & Woollacott, 2013). Although similar patterns of joint movement and center of gravity excursion are observed in young and older adults during a reactive recovery response, in older adults, a larger proximal joint rotation induces a larger sway, contributing to inefficient posture recovery (Tsai, Hsieh & Yang, 2013). Corrective strategies for postural control are initiated later in older adults and often are disorganized, with both agonist and antagonist muscles being activated simultaneously, resulting in a general stiffening of the limbs (Shephard, 1997). For example, when using the hip strategy to prevent a loss of balance, older adults exhibit a reduced ability to use the thoracic-lumbar joint to compensate for the movement of the hip joint, contributing to instability (Hsu, Chou, & Woollacott, 2013). Ankle strength also significantly declines with aging, affecting the plantarflexor muscles’ role in supporting the weight of the body and providing stability at the ankle and feet when standing. The role of the dorsiflexor muscles in counteracting gravity during the swing phase of gait is also adversely affected. In addition, range of motion of the ankle joint, namely during eversion, is reduced, contributing to increased sway (Kok, Lee, & Lee, 2013). Age-related changes also influence gait variability. Gait variability, meaning stride-to-stride fluctuations, is linearly increased with age and is considered a marker for gait performance and future mobility status, cognitive status, and falls (Callisaya, Blizzard, Schmidt, McGinley, & Srikanth, 2010; Maki, 1997). Overall, research has shown that older adults adopt a gait pattern that is characterized by a reduced step velocity and stride length when compared to young adults, particularly during obstacle avoidance (Lowrey, Watson, & Vallis, 2007; Menz, Lord, & Fitzpatrick, 2003). In general, a slower gait speed 40 manipulating the level of challenge associated with each set of progressions presented to the group. Basis for the program Previous randomized controlled trials have shown that the greatest improvements in indirect clinical balance outcomes are associated to exercise programs including gait, balance, co-ordination and functional tasks training; strengthening exercise; 3D exercise and multiple exercise types, as it was verified in the systematic review developed by Howe et al. (2011). Taking into account these results and referring to the same terminology, the ProBalance is a multiple exercise types program, including exercises that fit the following categories: balance, co-ordination and functional tasks training, gait training, strengthening and flexibility exercises and 3D training. However, in our work, the terminology used to describe the components of the ProBalance exercise program is the one used in the FallProof program (Rose, 2010), as it was the main inspiration for the development of this intervention. The exercise intervention included six key components, which will be further addressed: (1) center of gravity control training; (2) multisensory training; (3) postural strategy training; (4) gait pattern enhancement and variation training; (5) strength and endurance training; and (6) flexibility training. Center of gravity control training Center of gravity control training aims to improve the older adult’s ability to maintain body alignment in the upright and in the seated position; to lean and return to a central position and to move the body fast and confidently. In a variety of exercise, the older adults is oriented to move his center of gravity over the base of support, progressing from the seated to the upright position and then to moving tasks, the challenge is increased gradually (Rose, 2010). Multisensory training Multisensory training addresses the visual, vestibular and somatosensory systems, aiming to optimize the functioning of the unimpaired sensory systems and compensate for the systems that are known to be permanently impaired. This component includes exercises designed to improve the functioning of the somatosensory system by reducing or removing visual inputs; to improve the use of vision by manipulating the somatosensory inputs; to improve vestibular system function by manipulating both the visual and somatosensory systems; and to enhance the coordination between the visual and the vestibular systems. All older adults, even older adults that show good sensory reception 41 and integration skills, benefit from engaging in sensory stimulation activities, counteracting the age-related changes known to affect the sensory systems. However, in face of sensory impairments, two strategies are incorporated in the training: (1) the forced use of an impaired sensory system, when the impairment is temporary or changeable and (2) the forced use of the other systems in order to compensate or substitute a permanently impaired system (Rose, 2010). Postural strategy training According to Rose (2010), postural strategies training can be done by manipulating the task and the environment, to enable the older adult to practice the ankle, hip and step strategies. Three main approaches are mentioned by the author: (1) standing on different support surfaces; (2) voluntarily swaying through an increasingly larger distance in multiple directions, when standing in different support surfaces; and (3) controlling postural sway in response to progressively stronger applications of external forces. Training progression is done from the ankle strategy, to the hip strategy and the to the step strategy. This type of training, at a conscious level, aims to develop the older adult’s ability to respond to expected or unexpected events with efficient proactive and reactive postural strategies. Gait pattern enhancement and variation training An efficient, flexible and adaptable gait pattern is required for successful and safe locomotion in different environments, with specific timings and spatial demands, and changing tasks. Referring to gait pattern enhancement and variation training, Rose (2010) describes five strategies: (1) walking with directional changes and sudden starts and stops; (2) walking with an altered base of support; (3) varying the gait pattern (side stepping, braiding, tandem walking); (4) obstacle negotiation or avoidance; and (5) gait pattern enhancement and variation obstacle course. In overall, this set of progressive gait activities are designed to enhance gait pattern and give the older adult the ability to change postural orientation, in response to environmental demands. Strength and endurance training Postural alignment, balance and good mobility require adequate muscle strength and endurance. Therefore, Rose (2010) suggests that a balance and mobility program should include activities that increase strength and power, both in the upper-body and lowerbody. In addition, the author highlights the importance of incorporating strength and power exercises in a balance environment. Materials such as resistance bands, weighted balls 42 and hand weights are used in this training component, allowing progressions from less resistant or less heavy to more resistant or heavier. Flexibility training Flexibility exercises target the improvement in the range of motion of joints and muscles in the upper and lower-body, which are necessary for good balance and mobility. 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Changes in posture control across the life span: A systems approach. Physical Therapy, 70(12), 799-807. Woollacott, M.H. & Shumway-Cook, A. (1996). Concepts and methods for assessing Postural Instability. Journal of aging and physical activity, 4, 214-233. 56 tandem walking (item 5), standing on one leg (item 6), standing on foam with eyes closed (item 7), jumping for distance (item 8), walking with head turns (item 9), and recovering from an unexpected loss of balance (item 10). Each item is scored on an ordinal scale ranging from 0 to 4 points. The maximum possible score for the FAB scale is 40 points. Further details referring to the protocols of administration, equipment and an explanation about static and dynamic balance activities are described in Rose (2003) and Rose (2010). Strength and other functional fitness components measured by Senior Fitness Test components Strength (upper and lower body) was part of the Senior Fitness Test (SFT) assessment. This fitness test battery was developed by Rikli and Jones (1999a, 1999b) and it is appropriate for older adults, since it reflects the major physical parameters associated with functional mobility. This battery includes measures of upper - and lower body strength and also flexibility, aerobic endurance, dynamic balance and agility, height and weight. To minimize the effects of fatigue, stations were arranged in the following order: chair stand test (lower body strength), arm curl test (upper body strength), chair sit and reach test (lower body flexibility), back scratch test (upper body flexibility), 8-foot up-and-go test and (agility/dynamic balance). The 6-minute walk test (aerobic endurance) was administered after all other tests and questionnaires had been completed. All participants received the same instructions about the procedures of each test and they completed one or two trials to become familiarized with the task. A detailed description of the evaluation procedures, namely, equipment, procedure, scoring and safety precautions can be found in the SFT manual (Rikli & Jones, 2001). The anthropometric measures were obtained according to the standardized procedures described by Claessens et al. (1990). Height was measured with a Harpenden stadiometer (Holtain Ltd.). The measures were recorded to the nearest millimeter. Body mass was measured on a balance-beam scale accurate to 0.1 kg (Seca Optima 760, Hamburg, Germany). Participants wore light, indoor clothing without shoes and jewelry during the measurements. Measurements were performed twice and a third measurement was carried out in case of excessive difference. The scores of the two or the two closest measurements were averaged to reduce measurement error. Gait parameters measured by the 30-foot (9 m) walk test at preferred and maximum speed The 30-foot (9 m) walk test is a useful measure to assess gait speed and the indication of whether an older adult is able to adapt their gait speed to accommodate a change in task 57 demands. We also used this test in our study to identify functional limitation in mobility. Participants were required to walk a total distance of 50 feet (15 m), first at a preferred speed and then at a maximal speed, and the distance between 10 and 40 feet (3 and 12 m) was timed for the purpose of calculating gait velocity (GV) and other measures of gait. The number of steps was counted over the same 30 feet (9 m) distance, in order to calculate cadence (steps per second) and stride length (SL) (SL = divide number of steps by 2 to get the number of strides, and then divide 30 feet (9 m) by the number of strides to get the SL) (Rose, 2010). The gait stability ratio (GSR) is calculated from cadence and velocity and expressed in units of steps per feet (GSR is the ratio of cadence to velocity expressed in units of steps per foot meter) (Cromwell, & Newton, 2004). This last measure is a measure of gait stability, with higher values indicating more time spent with the feet in contact with the ground during the gait cycle. A full description of test administration instructions for 30 foot (9 m) walk test at preferred and maximum speed is reported by Rose (2010). Fear of falling measured by the Falls Efficacy Scale The Falls Efficacy Scale (FES) (Tinneti, Richman & Powell, 1990) was used to measure the fear of falling. The FES is a widely used, reliable, and valid criterion measure of fear of falling in Portuguese population (Melo, 2011). FES assesses an individual’s perceived confidence that the elderly present at the completion of 10 relevant and common activities, such as: (1) dressing and undressing; (2) prepare a light meal; (3) taking a bath or shower; (4) sitting/lift chair; (5) lying/get out of bed; (6) answer the door or the phone; (7) walking into the house; (8) reach for shelves; (9) light housework; (10) small purchases. The confidence that the elderly have to carry out the activities without falling, is represented in an analog 10-point scale ranging from "No confidence" (10 points) to "Completely confident" (1 point). The score of the FES is the sum of the scores obtained in each of the 10 items. The minimum score possible is 10 and the maximum is 100, meaning that the lower is the score, the greater the trust, translating into high self-efficacy. Health-related quality of life measured by the Medical Outcomes Survey Short Form-36 Health Related Quality of Life (HRQOL) is the perception by the individuals regarding their position in life, in the context of their culture and value systems, and in relation to their goals, expectations, standards, and concerns (WHO,1993). The Medical Outcomes Survey Short Form-36 (MOS SF-36) questionnaire was administered in our study to assess HRQL (Ware & Sherbourne, 1992).The MOS SF-36 is a widely used, reliable, and 58 valid criterion measure of HRQL in numerous populations, including in Portuguese people (Ribeiro, 2005). The MOS SF-36 questionnaire has 36 questions that are scored to measure eight domains of HRQL pertaining into two-components: a Physical Component and a Mental Component (Ware & Sherbourne, 1992). The Physical Component comprises: (i) physical functioning, (ii) role-physical (role limitations due to physical health problems), (iii) bodily pain, and (iv) general health. In relation to Mental Component, are included: (i) vitality, (ii) social functioning, (iii) role-emotional (role limitations due to emotional problems), and (iv) mental health. Each domain was scored using a scale ranging between 0 and 100, with higher scores indicating a higher HRQL than lower scores. Finally, scores were summarized into two components, namely physical and mental. Cognition, assessed by Mini-mental State Test The Mini-Mental State Examination (MMST) (Folstein, Folstein & McHugh, 1975) was used to measure the mental state. The MMST is a widely used, reliable, and valid criterion measure that provides information on different cognitive parameters, containing questions grouped into seven categories, each designed to evaluate cognitive "functions" as a specific orientation to time (5 points), spatial orientation (5 points), registration of three words (3 points), attention and calculation (5 points), recall of three words (3 points), language (8 points) and visual constructive ability (1 point). The MMST score can range from a minimum of 0 points, which indicates a higher degree of cognitive impairment of individuals, up to a maximum total of 30 points, which, in turn, corresponds to better cognitive ability. The MMST questionnaire was validated in the Portuguese population by Guerreiro et al. (1994). The cut-off points defined by Guerreiro et al. (1994) was used in the present study to detect cognitive impairment (without education ≤ 15 points; 1-11 years of education: ≤ 22 points; and higher than 11 years of education: ≤ 27 points). Physical activity measured by the Modified Baecke Questionnaire Habitual physical activity was assessed during face-to-face interviews using the modified Baecke Questionnaire developed in the Netherlands (Voorrips, Ravelli, Donelmans, Deurenberg & Staveren, 1991). The participants were asked to report habitual physical activities with a reference time period of last year. This questionnaire includes three specific domains: household activities, sport activities, and other physically active leisure time activities. Items on household activities are questions with four to five possible ratings, ranging from very active to inactive. Sports and other activities are asked as type of activity, hours per week spent on it, and period of the year in which the activity is 59 normally performance. All activities are classified according to work posture and movements. An intensity code, originally based on energetic costs was used to classified each activity (Bink, Bonjer, & Sluys, 1966). A detailed description of the scoring procedures for calculation of habitual physical activity and its subcomponent categories (household activities, sport activities, and other physically active leisure time activities) is provided by Voorrips et al. (1991). The questionnaire took about 20 minutes to complete. Number of fallers and total number of falls assessed by the health history questionnaire Demographic information and a complete health history were assessed during face-to- face interviews. A modified version of the health questionnaire employed in the FallProof! Programme (Rose, 2003) was used to assess information about pathology/disease and lifestyle characteristics. The section of pathology/disease included: diagnosis of pathologic condition (heart attack; transient ischemic attack; angina; high blood pressure; stroke; peripheral vascular disease; diabetes; neuropathies; respiratory disease; Parkinson’s disease; multiple sclerosis; polio/post-polio syndrome; epilepsy/seizures; other neurological conditions; osteoporosis; rheumatoid arthritis; other arthritis conditions; back problems, visual/depth perception problems; inner ear problems/recurrent ear infections; cerebellar problems; chemical dependency; depression); cancer; joint replacement, cognitive disorders, uncorrected visual problems, and other type of health problem. The information about lifestyle characteristics included: information about symptoms in legs or feet (numbness, tingling, arthritis, and swelling); eyeglasses (eyesight was checked at least once a year); hearing aids; assistive device for walking; the list of all medication that participants currently took (including all over-the-counter and alternative medicines). Specific questions about life events was also asked to participants, including: emergency medical care or hospitalization in last year; condition or injury that has affected balance or ability to walk without assistance; falls in the last 6 months and in the last year (date, location, reason) and concerns about falling. 3.9 Ethical considerations Participants were informed about the objectives, procedures, implications and their rights. The contact of the responsible researcher was available for questions or doubts, at any time during the trial. Also, the same intervention was available for the control group after the end of the trial, due to ethical issues. Written information was offered with this information for analysis by the participants prior to consent (Appendix IV). Therefore, informed consent was provided by all participants at the enrolment phase, as seen in Appendix V. 60 Ethical approval for the ProBalance Project was granted by the Ethics Committee of the Health Service of the Autonomous Region of Madeira in January 2011 (Appendix VI). 3.10 Quality control To ensure the quality of the execution, feasibility of the procedures and reliability of all measures were tested in the piloting phase of this research, through a pilot study. The pilot study consisted in a "mini-RCT" that was performed between November and December 2011. The purposes of the pilot study were: (1) to estimate the test-retest reliability of the Fullerton Advanced Balance (FAB) scale (Rose, 2010); (2) to assess participant’s recruitment, adherence and retention in the ProBalance Program; and (3) to examine short-term changes in balance-related outcomes. This "mini-RCT" consists on a 4-week controlled trial, incorporating the pilot study of the ProBalance intervention designed to improve balance in older adults. This “mini-RCT” was prospectively registered in the Australian New Zealand Clinical Trials Registry Platform and the clinical trial registration number is ACTRN12611001164987 (for further details on the international registry, see http://apps.who.int/trialsearch/Trial.aspx?TrialID=ACTRN12611001164987). The sample comprises 80 healthy community-dwelling men and women aged 65-80 years from Autonomous Region of Madeira (ARM), Portugal. In total, 6 eligible older adults were randomly allocated to the intervention group and other 6 to the waiting-list control group receiving usual care. The inclusion criteria of the pilot study were: (1) community-dwelling older adults aged 65-80 years; (2) to report at least one fall in the last year, or no falls, if FAB score was equal or lower than 30/40; and (3) to be able to walk independently. The exclusion criteria were: (1) the presence of cognitive impairment (assessed by the MMST); and (2) significant co-morbidities that would preclude participation (acute illness, progressive neurological disease, stroke, and unstable chronic conditions). Informed consent was signed and the volunteers were received at the laboratory of the University of Madeira for assessments. A simple randomization process was used to allocate the participants to Intervention Group and Control Group using a coin toss. 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(2001). Senior fitness test manual. Development and validation of a functional fitness test for community-residing older adults. Champaign, IL: Human Kinetics. Rose, D.J. (2003). FallProof! A comprehensive balance and mobility training program. Champaign: Human Kinetics. Rose, D.J. (2010). FallProof! A comprehensive balance and mobility training program (2nd Ed.). Champaign: Human Kinetics. Rose, D.J. (2011). Reducing the Risk of Falls Among Older Adults: The Fallproof Balance and Mobility Program. Current Sports Medicine Reports, 10(3), 151-156. Tinetti, M. A., Richman, D., & Powell, L. (1990). Falls Efficacy As A Measure Of Fear Of Falling, Journal of Gerontology, 45(6), 239-243. Voorrips, L.E., Ravelli, A.C.J., Dongelmans, P.C.A., Deurenberg, P., & Staveren, W.A.V. (1991). A physical activity questionnaire for the elderly. Medicine and Science in Sports and Exercise, 23(8), 974-979. Ware, J.E. & Sherbourne, C.D. (1992). The MOS 36-item Short-Form Health Survey (SF- 36): I. Conceptual framework and item selection. Medical Care, 30, 473-83. Ware, J.E., Kosinski, M., & Keller, S.D. (1994). SF-36 Physical and Mental Health Summary Scales: A Users' Manual. Boston: The Health Institute. WHO [World Health Organization]. (1993). Study protocol for the World Health Organization project to develop a Quality of Life assessment instrument (WHOQOL). Quality of Life Research, 2(2), 153-159. 63 Chapter 4 Therapeutic exercise in Gerontological Rehabilitation: A literature analysis B.R. Gouveia, H. Jardim, M. Martins Bridge This chapter comprises a theoretical article elaborated in the beginning of this research project. At the time, the research problem was not yet defined, and the review of literature addressed general clinical problems and theoretical issues. This article, entitled “Therapeutic exercise in Gerontological Rehabilitation: A literature analysis”, targets a very broad topic, namely the associations between therapeutic exercise interventions and posture, gait and functional fitness in the older adults, as well as the role of rehabilitation nurses in this domain. However, important conclusions were drawn from this literature analysis, contributing for the understanding of the reasons that led a narrower research question in the present research process. A version of this article, in the Portuguese language, was published in 2013 on an international scientific nursing journal, namely, Referência (Qualis B2). This and other publications are described in the list of publications derived from this research (Appendix VII). 64 Abstract With an aging population and an increasing demand of specific health care, from the standpoint of Rehabilitation Nursing, strategies to deal with potential determinants of the aging process that affect mobility should be based on current research results. Therapeutic exercise, also known as kinesiotherapy, consists of a basic tool for the rehabilitation nurse specialist. However, few studies address the rationale and the applicability of such techniques in the context of gerontological rehabilitation. This theoretical essay aimed to: (1) describe the associations between posture, gait and functional fitness in the older adults and therapeutic exercise interventions, and (2) identify references to the intervention of rehabilitation nurses in this domain. We performed a review of literature with a reference search in all health journals included in the electronic database EBSCO HOST, published in the last 15 years. The analysis was qualitative, 168 articles were identified, of which 11 met the inclusion criteria. The studies analyzed showed complementary results, describing benefits of therapeutic exercise on posture, gait and functional fitness in older adults. In the revised studies, special relevance is also given to balance as a related outcome. In balance, combined exercise was associated to significant improvements. There were no references to rehabilitation nurses’ intervention. Further research is needed to describe the specificity of therapeutic exercise in gerontological rehabilitation and the work of the rehabilitation nurse specialist in this field. Key words: Rehabilitation Nursing, Aged, Mobility Limitation, Exercise. 65 Introduction Recognizing the problematic that accompanies the demographic aging in Portugal and in the World, the dependence growth ratios (Statistics Portugal, 2009) and the increasing demands in health care, the gerontological rehabilitation is an area of growing interest. Although therapeutic exercise, also known as kinesiotherapy, is recognized by specialist rehabilitation nurses as a basic feature in the clinical context, the lack of studies that address the rationale and the applicability of such techniques in the specific context of gerontological rehabilitation, determined the relevance of this research. Thus, the clinical practice with older people as rehabilitation nurses, and specifically the need to validate an action plan focused on preventing limitations on mobility of older adults, led to the departure issues of this work: Which associations exist between the posture, gait and functional fitness of the older adults and therapeutic exercise? Are there publications discussing therapeutic exercise as an intervention used by the rehabilitation nurse specialist in the care of older adults? In order to answer these questions, this article will have the following objectives: (1) to describe the relationships between posture, gait and functional fitness of older adults and therapeutic exercise interventions and (2) to identify references to the intervention of specialist nurses in this rehabilitation domain. Intending to elaborate a theoretical article, we performed a literature review through a qualitative analysis of the type of articles published in refereed journals, an electronic survey was conducted using the database EBSCO HOST, selecting all databases in the area of health included in it. The publication period was set between January 1995 and January 2010 and the keywords used were: aging, older adults, aged, gerontological rehabilitation, nursing, posture, gait, physical fitness, mobility, therapeutic exercise, and exercise. The research findings were vast, however, were excluded from this analysis and cataloging, all studies concerned other aspects, not biological or kinesiological of human aging, all literature reviews on the theme, all studies that studied only situations of specific pathology, as well as indexed without full-text articles available. Given these criteria, were identified by analyzing the title, 168 articles of these, were selected 11, presenting relevant references on the topic under study in the abstract, for a later full review. It should be noted that in the abstract analysis , were considered for inclusion, studies that refer to exercise interventions with results in variables associated with posture, gait and functional fitness components, as well as, in studies that targeted older adults described as healthy or with functional disability. Of these, 11 were selected, presenting relevant references on the topic under study in the abstract, for a later full review. Since the term kinesiotherapy was not found as a descriptor in the studies or in the database, 72 Author / Year of Publication Title of the study Country Type of Study Objective Methodology Sample Relevant conclusions Ribeiro et al. (2009) Gym Program for the older adults at Health Center: assessment of functional fitness. Brazil Experimental Analyze the influence of an exercise program for 24 weeks and a period of 8 weeks detraining on functional fitness of older adults from four Health Centers. An exercise program, 3 times per week (24 days), followed by detraining (8 weeks) was applied to the sample; Functional fitness was assessed using the battery of tests AAHPERD. The sample included 14 subjects; Average age 67.78 years; females. The program contributed to improving overall functional fitness of older adult women. The upper limb strength and coordination achieved major changes. In the period of detraining program, an improvement in aerobic endurance was noted. Fahlman et al. (2007) Combination training and resistance training as effective interventions to improve functioning in elders USA Experimental Determine whether resistance training or a combination of resistance and aerobic training improves functional fitness in older adults with limitations. The sample was divided into three groups: the experimental group 1 was applied to resistance training; the experimental group 2, combination of resistance and aerobic training; The control group had no intervention; An assessment of strength and functional fitness (6 tests) was performed before and 17 weeks after training. The sample included 109 subjects; 74.6 Middle Ages; 75.8 and 76.5 years, respectively, for the 3 groups. The resistance, endurance and aerobic training were able to significantly increase strength, endurance and functional fitness of older adults with limitations. Mota et al. (2006) Physical activity and health related quality of life in older adult participants and non-participants in regular physical activity programs Portugal Experimental Compare the quality of life among participants in formal programs of physical activity and nonparticipants, and to determine The sample was divided into two groups: Control group (n = 42) not included in the exercise program and an experimental (n = 46) group, which was involved in a physical activity program; The sample included 88 subjects; Age greater than 65 years. Active older adults had a higher quality of life than older adults who did not participate in a physical activity program. 73 Author / Year of Publication Title of the study Country Type of Study Objective Methodology Sample Relevant conclusions factors that may predict such participation. Assessment of quality of life was performed by questionnaire SF 36. Carvalho et al. (2004) Muscle strength in older adults I - will be widespread enough intense training to promote increased muscle strength in older adults of both sexes? Portugal Experimental Determine the effect of a general program of physical activity, with a duration of 6 months, the maximum isokinetic strength of the knee extensors and flexors in older men and women. The sample was submitted for 6 months to a bi-weekly program of general physical activity; The maximum isokinetic strength of the knee extensors and flexors was assessed using an isokinetic dynamometer (Biodex System 2, USA) in two different speeds (60 and 180 sec.) before and after the training program. The sample included 26 subjects; Average age 68.1 for men (7) and 69.5 in women (18). The results showed there were no significant changes in muscle strength in older adults after general training. Verfaille et al. (1997) Effects of resistance, balance, and gait training on reduction of risk factors leading to fall in elders. USA Experimental Compare the effects of resistance training alone or combined resistance training, balance and step (gait) in balance and gait of older adults. The sample was divided into two groups: the experimental group to which was applied the combined training and the control group, with resistance training and relaxation; 12-week intervention was implemented; Assessments of strength (maximum voluntary contraction), gait (gait velocity and step length), static balance (Romberg signal), and dynamic balance (tandem walk) were performed prior and after the intervention. The sample included 39 subjects; Ages between 65 and 83 years. Both groups showed increased strength and gait velocity; Only in the combined training significant improvements in balance and gait were observed. 74 The different typology of studies enabled us to take different conclusions. Particularly in descriptive studies, we obtained indicators of relations between functional fitness and physical activity or general movement. On the other hand, the set of revised experimental studies emphasized the effect of various types of therapeutic exercise interventions, on posture, gait and functional fitness of older adults. Referring to interventions that impact on posture and gait, the reviewed studies make reference to single and multiple exercise type intervention with positive impact on these variables. The studies reviewed showed that aerobic and resistance training had a positive effect on strength and functional fitness of older adults (Fahlman et al., 2007), and also balance and gait, particularly when associated with balance and gait training (Verfaille et al. 1997). Muscle strength and walking velocity training were associated with improvements in functional fitness, strength and gait (Protas & Tissier, 2009). General exercise training and walking, as well as general physical activity, were associated with a generalized increase in muscle strength and improved posture and gait (Caromano et al, 2009; Carvalho et al, 2004). Also, general physical activity was associated with a greater mobility capacity (Malmberg et al. 2006), and improved quality of life (Mota et al., 2006), inferior functional fitness decline (Laukkanen, Kauppinen & Heikkinen, 1998) and better survival rates (Sihvonen, Rantanen & Heikkinen, 1998). As result, these findings allow us to identify also other variables associated with this subject, which have not been analyzed in the present research. Despite the complementary results of the various studies, consideration should be given to the studied populations. The studies were conducted in different countries of Europe, America and Australia, which determines the possibility of detachment of the contextrelated variables, which is not analyzed in this work. An example is the different opportunities to exercise and the availability of rehabilitation services. The results of this study, that examined the existing scientific evidence on the relationship between posture, gait and functional fitness of older adults and therapeutic exercise interventions, confirm the beneficial effects of the kinesiotherapy interventions previously described (Jones & Rose, 2005; Stott et al., 2006). The professionals involved in the practice of therapeutic exercise The referenced studies lead us to see that the research has been growing within the gerontological rehabilitation in recent years. It has been found that most of the analyzed studies were published in the last five years. However, we found that this approach is 75 taken from different areas of study and different professionals involved in the rehabilitation of older adults, particularly in the area of physical education, sports and physical therapy, while the expression of rehabilitation nurses seldom mentioned in this context. When we tried to document the specialist rehabilitation nurse intervention, it was found that this was not studied or cited in any studies identified in this review, glimpsing the low profile of this professional in the existing publications on this topic. However, specializations in rehabilitation nursing do not exist, are relatively recent or are not certified in many countries worldwide. Unlike what happens in Portugal, the universe of these professionals in the world could be limited in relation to others in the field of rehabilitation, determining a smaller number of scientific publications in journals indexed in the searched database. In most of the studies, the need for development of further research in this area is stated, which is reinforced by the results of this analysis of the literature. This analysis of the literature allowed us to identify the positive impact of various exercise interventions, as well as other important variables that could be addressed in further research on this topic. In the revised studies, special relevance was given to balance. Balance and balance-related outcomes (as strength and gait), have shown to be an important focus of this type of research, due to its importance in the functionality of older adults. Further analysis of this topic should target these variables. Therapeutic exercise is associated to benefits in posture, gait, and the components of functional fitness, as well as balance, in older adults, with resulting effects on global mobility, quality of life and also survival. The reviewed studies are limited and partially addressed the subject of this review; however, we observed coherence and complementarity in the findings. Through the analysis of existing scientific evidence on the subject of the present review, the results of this study confirm the applicability and relevance of therapeutic exercise interventions in the context of gerontological rehabilitation. It is important to undertake the limitations of this study. First, this study comprises a review of literature and qualitative analysis of the results; however, the generalizability of the results is compromised. The option for another design (a systematic review of literature or a meta-analysis) would be necessary to overcome this limitation. Second, the availability of full-text retrieval as inclusion criteria and the inability to analyze quantitatively the cause-effect relationships identified due to the different methodologies used in the reviewed studies. Lastly, the vast scope of the subject may have limited the depth of the study, however, allowing an overview of the beneficial effects of therapeutic exercise. 76 The contribution of various disciplines is an asset in gerontological rehabilitation, suggesting that a multidisciplinary intervention could be advantageous in the clinical setting. In addition, the existent published scientific literature, does not address therapeutic exercise (kinesiotherapy) in older adults held by rehabilitation nurses. As a practical implication of these findings, we believe that the identification of this gap in literature can be an incentive for rehabilitation nurses, towards the production of scientific research that demonstrates health gains from exercise interventions, which we consider a mainstay of clinical practice in the field of gerontological rehabilitation nursing. Conclusion Therapeutic exercise, also known as kinesiotherapy, is a technical resource for the rehabilitation nurse specialist in gerontological rehabilitation. Therefore, it is important attest its fundament and applicability. This analysis of the literature allowed us to describe the beneficial effect of various therapeutic exercise interventions, in posture, gait and functional fitness of older adults, as well as balance, justifying its relevance in gerontological rehabilitation. The results of 11 studies that examined the relationship between posture, gait and functional fitness of older adults and exercise interventions, reinforce the importance of this type of intervention in the context of gerontological nursing rehabilitation. Seeking to meet the second objective of this study, namely to identify references to the intervention of a rehabilitation nurse specialist in this field, the reviewed studies show the absence of references to these professionals. We believe that the published scientific literature reviewed in this article, does not show the scope of the therapeutic exercise interventions held by rehabilitation nurses, particularly in Portugal, where they are recognized and certified professionals. More studies are needed to define the specificity of therapeutic exercise in gerontological rehabilitation nursing, and assess the effect of specific intervention plans in gerontological rehabilitation nursing that can be applied and reproduced in the clinical context. References Amundsen, L.R. (2007). Effects of age on joints and ligaments. In Kauffman, T.L., Barr, J.O., & Moran, M.L. (Eds.), Geriatric rehabilitation manual (2nd Ed.) (pp. 17-19). Philadelphia: Elsevier Caromano, F.A., Ide, M.R., Kerbauy, R.R., & Streit, M.V. (2009). Estudo comparativo dos efeitos de dois programas de exercícios - caminhada e exercícios gerais - na 77 postura e marcha em idosos sedentários saudáveis. Revista Varia Scientia, 7 (13), 113-124. Carvalho, J., Oliveira, J., Magalhães, J., Ascensão, A., Mota, J., & Soares, J.M.C (2004). Força muscular em idosos I - Será o treino generalizado suficientemente intenso para promover o aumento da força muscular em idosos de ambos os sexos?. Revista Portuguesa de Ciências do Desporto, 4 (1), 51-57. Doherty, T.J. (2003). Invited Review: Aging and sarcopenia. Journal of Applied Physiology, 95, 1717-1727. Fahlman, M., Morgan, A., McNevin, N., Topp, R., & Boardley, D. (2007). Combination training and resistance training as effective interventions to improve functioning in elders. Journal of Aging and Physical Activity, 15 (2), 195-205. Germain-Lee, E.L., Checovich, M.M., Smith, E.L., & Lundin, K. (2007). Effects of aging on bone. In Kauffman, T.L., Barr, J.O., & Moran, M.L. (Eds.), Geriatric rehabilitation manual (2nd Ed.) (pp. 13-15). Philadelphia: Elsevier. Guimarães, L.S., & Cruz, M.C. (2003). Exercícios terapêuticos: A cinesioterapia como importante recurso da fisioterapia. 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Journal of Aging and Physical Activity, 5, 213-228. 79 Chapter 5 The ProBalance Program for improving balance in older adults: A pilot study Bridge This chapter comprehends an article reporting the first research study developed in the context of the ProBalance project. This article is entitled “The ProBalance Program for improving balance in older adults: A pilot study”. This study is a pilot randomized controlled trial focused on the feasibility of the ProBalance program. Results address the reliability of all assessments, and recruitment, adherence and retention rates, as well as, a preliminary analysis of short-term changes in balance-related outcomes. This article is under review by co-authors for submission to the Archives of Physical Medicine and Rehabilitation. 80 Abstract Exercise seems to be moderately effective in improving clinical balance outcomes. This study investigates the feasibility of the ProBalance program - Prehabilitation and Rehabilitation Nursing: balance/fall risk in a community-dwelling older adults, in terms of reliability of assessments, recruitment, adherence and retention rates. A specific aim is to examine short-term changes in balance-related outcomes. A total of 80 community-dwelling older adults, aged 65-80 years, were assessed for eligibility. Twelve women (mean age of 72.8±3.4 years) were randomized into the ProBalance intervention group (IG) (n = 6) and into a non-intervention wait-list control group (CG) (n = 6). The IG undertook 12 training sessions of 60 minute each, three times per week, during four weeks. Pre- and post-test assessments included balance, gait parameters, functional fitness, health-related quality of life (HRQL), cognition, falls, and physical activity. The study protocol and intervention were fully applied and a high adherence and retention was verified (100%). Intraclass correlation coefficient (R) for the total Fullerton Advanced Balance scale score was 0.885. In gait parameters, R ranged between 0.717 (velocity) and 0.799 (stability ratio). For functional fitness, R was between 0.689 (arm curl) and 0.987 (back scratch). High R values were also found for HRQL- physical (0.984) and mental (0.930), cognition (0.789), falls efficacy (0.940), and habitual physical activity (0.978). Only in the IG, there was a statistically significant increase in total FAB scale score (p = 0.007), arm curl (p = 0.041), and HRQL- physical (p = 0.019) and mental (p = 0.013) from baseline to post-intervention. In the CG, significant changes were seen in cadence (p = 0.024) and chair-sit-and-reach test (p = 0.029). No statistically significant differences were observed in the remaining variables, in both, IG or CG. This study demonstrates that the ProBalance program is feasible (in terms of reliability of assessments, recruitment, adherence and retention) and has a promising effect on balance scores of older adults. A larger sample and a longer intervention period are needed in order to test the program’s efficacy. Key words: Rehabilitation nursing, ProBalance Program, Reliability, Balance, Community-dwelling, Older adults. 81 Introduction Falls in older adults living in the community and its impact on individual and public health is a major concern for the health care and for the society (WHO, 2007). Previous studies have shown that falls are the most frequent accident and the leading cause of fatal injury in older adults. In the European Union, 53% of the total injury deaths and 82% of fatal fall injuries, happened in people 60 years and older. In this age group, falls accounted for 28% of all causes of injury-related deaths (EuroSafe, 2013). In Portugal, 15% of domestic and leisure accidents happened in the older adults (65 and older) and falls accounted for 87.1% of all accidents in older adults aged 65-74 years (NHORJ, 2011). In the Autonomous Region of Madeira (ARM), Portugal, Gouveia (2011) reported that 36% of a sample of community dwelling older adults had, at least, one fall in the past year. This is in line with worldwide studies showing that at least, 30% of community-dwelling older adults (aged 65 and older) experienced one or more falls each year and that 10 to 15% of these falls were associated with serious injuries (American Geriatrics Society, British Geriatrics Society, & American Academy of Orthopaedic Surgeons Panel on Falls Prevention, 2001; Gillespie et al., 2012; Rubenstein, 2006; Sturnieks, George, & Lord, 2008). Falls seem to be multifactorial in their origin. Chronic conditions, balance and gait impairments, functional disabilities, general physical inactivity, vision problems, cardiovascular factors, and medications are predisposing factors for falls, while home hazards, footwear, and multifocal or new glasses are precipitating factors (Tinetti & Kumar, 2010). It was also shown that balance declines with aging (Rose, 2010) and that poor balance is associated with an increased risk of falling (Howe, Rochester, Neil, Skelton, & Ballinger, 2011). There is scientific evidence that some types of exercise are moderately effective in improving clinical balance outcomes and reducing falls in older adults (Balzer, Bremer, Schramm, Lühmann, & Raspe, 2009; Costello, & Edelstein, 2008; Gillespie et al., 2012; Sherrington et al., 2008; Howe et al. 2011). Finally, there is evidence that some types of exercise including gait, balance, co-ordination and functional tasks, strengthening exercise, 3D exercise and multiple exercise types are moderately effective in improving clinical balance (Howe et al., 2011). In this context, high methodological quality research using core outcome measures and adequate surveillance is necessary to accomplish more robust evidence on this topic. According to Portney and Watkins (2009), reliability represents the extent to which a measurement is consistent and free from error. This study investigates the feasibility of the ProBalance Program - Prehabilitation and Rehabilitation Nursing: Balance/fall risk in community-dwelling older adults. At the most specific level, the purposes of the present study were: (1) to estimate the test-retest reliability for all measures including balance; (2) 88 Table 5.1 Test-retest reliability for balance, gait parameters, functional fitness, health-related quality of life, cognition, falls efficacy, and habitual physical activity: pilot study (n = 12). Test Retest Variables M (sd) M (sd) R 95% CI Balance Total FAB (score) 28.25 (2.01) 28.58 (2.39) 0.885 0.611-0.967 Gait Velocity (m/sec)† 1.57 (0.20) 1.67 (0.26) 0.717 0.112-0.916 Stride length (m/stride)† 1.40 (0.13) 1.48 (0.14) 0.795 0.095-0.946 Cadence (Steps/sec) † 2.25 (0.18) 2.26 (0.27) 0.724 -0.015-0.922 Stability ratio (steps/m)† 1.44 (0.14) 1.36 (0.13) 0.799 0.133-0.946 Functional fitness Chair stand test (n) 14.92 (2.64) 16.17 (2.08) 0.827 0.251-0.953 Arm curl test (n) 16.67 (3.14) 16.58 (2.75) 0.689 -0.158-0.912 Chair sit-and-reach test (cm) 2.96 (9.44) 2.58 (9.39) 0.923 0.732-0.978 Back Scratch test (cm) -15.53 (9.28) -15.21 (9.82) 0.987 0.957-0.996 8-foot up-and-go test (s) 6.05 (0.78) 5.88 (0.80) 0.908 0.698-0.973 6-minute walk test (m) 461.42 (1.88) 487.73 (42.80) 0.813 0.319-0.949 Health-related quality of life Sf-36 physical component (score) 28.25 (2.01) 198.98 (51.89) 0.984 0.945-0.995 Sf-36 mental component (score) 1.57 (0.20) 254.06 (71.43) 0.930 0.753-0.980 Cognition Mini mental state test (score) 26.50 (2.65) 26.58 (2.27) 0.879 0.569-0.965 Fall efficacy scale (score) 89.92 (7.97) 91.25 (8.53) 0.940 0.801-0.982 Habitual physical activity (total; score) 5.31 (2.92) 5.25 (2.88) 0.978 0.924-0.994 M (sd), mean ± standard deviation; R, intraclass correlation coefficient; FAB, Fullerton Advanced Balance; CI, confidence interval.†walk a distance of 15 meters at a maximal speed. Main results for balance, gait parameters, functional fitness, HRQL, cognition, falls efficacy, and habitual physical activity at baseline and post-intervention are shown in Table 2. Only for the IG, there was a statistically significant increase in total FAB scale score from pre-test (M=27.83, SD = 1.83) to post-test (M=31.67, SD =2.42), t (5)= -4.39, p=0.007. Similar changes for the IG were seen for arm curl (functional fitness) [pre-test (M=15.83, SD = 2.64) to post-test (M=18.00, SD =2.10), t (5) = -2.74, p=0.041], HRQL – physical component [pre-test (M=171.28, SD =22.80) to post-test (M=232.37, SD =41.11), t (5)= -3.40, p=0.019], and HRQL – mental component [pre-test (M=217.36, SD = 65.34) to post-test (M=303.42, SD =33.86), t (5)= -3.735, p=0.013]. In the CG significant changes were seen in cadence (p = 0.024) and chair-sit-and-reach test (p = 0.029). In addition, no statistically significant differences were seen in all other gait parameters nor in the remaining functional fitness test in both groups (see table 5.2). 89 Table 5.2 Main results for balance, gait parameters, functional fitness, HRQL, cognition, falls efficacy and habitual physical activity at baseline and postintervention by group: control and intervention. CG (n = 6) IG (n = 6) Variables Pre-test‡ Post-test‡ ∆ score p Pre-test‡ Post-test‡ ∆ score p Balance Total FAB (score) 29.33±2.80 29.50±2.81 0.17 0.695 27.83±1.83 31.67±2.42 3.83 0.007 Gait Velocity (m/sec)† 1.60±0.13 1.67±0.11 0.07 0.158 1.74±0.34 1.68±0.34 -0.06 0.521 Stride length (m/stride) † 1.47±0.15 1.45±0.15 -0.02 0.363 1.49±0.14 1.53±0.14 0.04 0.181 Cadence (Steps/sec) † 2.19±0.20 2.32±0.23 0.13 0.024 2.33±0.33 2.19±0.36 -0.14 0.366 Stability ratio (steps/m)† 1.37±0.15 1.39±0.14 0.02 0.363 1.35±0.13 1.32±0.13 -0.04 0.175 Functional fitness Chair stand test (n) 17.67±1.03 16.67±1.97 -1.00 0.203 14.67±1.75 16.00±1.79 1.33 0.062 Arm curl test (n) 17.33±2.88 16.33±1.51 -1.00 0.229 15.83±2.64 18.00±2.10 2.17 0.041 Chair sit-and-reach test (cm) 7.25±6.80 9.75±7.87 2.50 0.029 -2.08±9.78 3.67±4.49 5.75 0.091 Back Scratch test (cm) -14.58±7.70 -16.42±6.22 -1.83 0.056 -15.83±12.33 -18.00±13.59 -2.17 0.068 8-foot up-and-go test (s) 5.64±0.55 5.85±0.83 0.21 0.279 6.11±1.00 5.85±0.78 -0.26 0.075 6-minute walk test (m) 477±56.48 466±62.69 -11.50 0.739 501±14.52 484±31.93 -16.43 0.186 Health-related quality of life Sf-36 physical component (score) 226.69±59.69 229.04±46.11 2.35 0.938 171.28±22.80 232.37±41.11 61.09 0.019 Sf-36 mental component (score) 290.75±61.03 268.33±75.83 -22.42 0.263 217.36±65.34 303.42±33.86 86.06 0.013 Cognition Mini mental state test (score) 26.17±2.79 26.67±3.14 0.50 0.681 27.00±1.79 27.00±3.41 -0.00 1.000 Fall efficacy scale (score) 91.83±6.68 89.17±11.89 -2.67 0.451 90.67±10.71 91.00±7.59 0.33 0.957 Habitual physical activity (total; score)) 6.25±3.78 5.86±3.18 -0.39 0.541 4.25±1.27 5.58±2.82 1.33 0.872 †Walk a distance of 15 meters at a maximal speed; ‡values are means and standard deviations; CG, control group; IG, intervention group; ∆ score, change between pre- and post-test 90 Discussion This work incorporates a pilot study of a larger scale RCT aiming to assess the effect of a gerontological rehabilitation nursing program in a group of community-dwelling older adults living in ARM, Portugal. The main outcome of this study was balance. One of the most important requirements of any assessment is reliability (Portney & Watkins, 2009). In the current study, the test-retest reliability for all measurements was between 0.689 and 1.000, indicating moderate to good levels of reliability (Safrit, 1990). The feasibility of ProBalance program in a 4-week RCT, involving 12 participants, was verified since the protocols and intervention were fully applied. Furthermore, high adherence and retention rates were seen in the pilot study, since all participants completed the two assessments and the intervention program or control. The efficacy of this pilot study was expressed by the change scores of the main balance outcome for the IG. For the total FAB scale scores, the IG showed a change score of 3.83 points, which represents a 40% decrease in fall risk, considering that a 1-point change in total FAB scale score is associated to an 8% change in fall risk (Hernandez & Rose, 2008). The intraclass correlation coefficient for balance was 0.885 in this study. This value is somewhat lower than that report by Rose, Lucchese, and Wiersma (2006) using a North- American sample of 31 community dwelling older adults (R = 0.96). All functional fitness tests have also shown moderate-to-high reliabilities (0.689 ≤ R ≤ 0.987). Except for arm curl test (that in our study we had the lowest reliability, R=0.689), in the remaining tests we found similar reliabilities than those report by Gouveia et al., (2013), ranged from 0.75 to 0.90 in 802 participants (401 men and 401 women) living ARM, Portugal. However, Rikli and Jones (1999a) reported test-retest reliabilities for SFT items higher than ours, ranged from 0.80 to 0.98. In the gait parameters we found lower but acceptable reliabilities, R ranged from 0.717 to 0.795, according to the cutoff point of 0.70 suggested by Safrit (1990). The second purpose of this study was to assess recruitment, adherence and retention in ProBalance program. The recruitment demanded an on-site screening to all volunteers. The eligibility rates among participants on this preliminary screening (15%) was lower than in a previous study by Ory et al., (2002). On the basis of the rigorous eligibility criteria and targeted sampling in our study, eligibility rates were low. Therefore, changes in the eligibility criteria could be a solution to increase the eligibility rate in main RCT. In regard to the retention in the program, all participants in this study completed the assessments and intervention program, and the protocol was fully applied. No adverse events related to the study were reported. However, an obstacle to participation was identified, specifically, the fact that the location of the study’s laboratory was not easily accessible by public 91 transportation. Recommendations to reduce the frequency of intervention can be considered in order to maintain adherence in longer periods of intervention. The third purpose of this pilot study was to examine short-term changes in balance-related outcomes. The efficacy of multidimensional interventions using multiple exercise types, for improving balance in older people has been previous reported by Howe et al. (2011). In general, the more effective programmes involved dynamic exercise in standing and ran for 12 weeks, three times per week. Another study by Westlake and Culham (2007) found improvements in the total FAB scale score after an 8-week exercise intervention. These results are in line with the current study, although our program consisted in 4-week intervention, 3 sessions per week, in a total of 12 hours of training. Notwithstanding, other pilot RCTs, with shorter periods of intervention also showed similar results (Kaesler et al., 2007; Nitz, Kuys, Isles, & Fu, 2010; Bateni, 2012; Kathleen, & Dold, 2013). In the current study, the use of the FAB scale and the type of intervention could explain the statistical increase in balance. As referred before, the ProBalance intervention is a theory-driven program, adopting a multidimensional approach to balance and mobility in independentliving older adults with balance impairments (Rose, 2010). In addition, we used the FAB scale that is a valid and reliable assessment tool (Rose, et al., 2006) for consider multi dimensions of balance. Our data showed a short-term increase in HRQL. There is accumulated evidence showing an association between participating in physical activity programs and physical and psychological well-being, with the reduction of depression and anxiety, and the increase of self-esteem and positive affect (Spirduso, Francis, & MacRae, 2005; McAuley et al. 2006, Fortuño-Godes et al. 2013). Again, we did not expect any short-term changes in HRQL dimensions in our pilot study. Probably, the main explanation for these results was the fact that the concept of quality of life is very broad and dynamic, with an emphasis on the subjective dimension (WHO, 1993). In general, the absence of any statistical significant difference between baseline and follow-up measurements in gait parameters and the majority of the functional fitness tests could be explained by the short duration of the training program. The significant changes seen in cadence and chair-sit-and-reach test for the intervention group could be explained by an increased awareness and motivation in the assessments, however, further research is needed to further analyze this relation and potential confounders. There are several limitations in this study. First, because this was a pilot study, with a small sample size and a reduce time of intervention, we had limited ability to find significant changes in all variables. Although we found significant difference in balance and HRQL, probably we did not have adequate power to detect small or moderate improvement in the other secondary outcomes. The sample size in this study was limited 92 by recruitment difficulties and time and financial restrictions. In addition, the participants were volunteers which may limit the generalizability to the population. Second, although the FAB scale is a practical balance assessment tool that is both valid and reliable, when used to assess multiple dimensions of balance in community-residing older adults (Rose et al., 2006), it is not a direct measure of balance. A combination of direct measures of balance, such as force platform, could be used in order to obtain a more accurate result. Despite the limitations, this study showed that the assessment and intervention protocols turned out to be feasible. The results achieved, namely, the high test-retest reliability of the measurements, the high adherence and retention of the participants during the intervention, as well as, the change scores in balance verified immediately after the intervention, suggested that the necessary conditions are granted for a high quality research to answer to the efficacy hypothesis in a larger RCT. In this feasibility study we shifted the emphasis from sample size to focus on methodological quality, in order to achieve a trial with less bias. These results could be combined with those from similar studies and included in a meta-analysis (Schulz & Grimes, 2005). Future Research The ProBalance program has been shown to be feasible and to have a promising effect on balance scores of older adults, under the circumstances of a pilot study of a RCT. However, the program’s efficacy needs to be evaluated in a RCT with a larger sample size and longer intervention period as well as follow-up. Conclusions The present study showed high levels of reliability for all variables. The protocols for assessments and for the intervention were fully applied, which illustrates the feasibility of the ProBalance program in the context of a pilot RCT. Eligibility rate was low (15%). However, all randomized participants (n=12) completed the assessments and intervention program, resulting in very high adherence and retention rates. The 4-week intervention was associated to improvements in clinical balance. These findings are supportive of further research on the efficacy of the ProBalance program. Nevertheless, inclusion criteria should be expanded in order to order to increase the eligibility rate. References American Geriatrics Society, British Geriatrics Society, & American Academy of Orthopaedic Surgeons Panel on Falls Prevention (2001). Guideline for the 93 Prevention of Falls in Older Persons. Journal of the American Geriatric Society, 49(5), 664–672. Arnold, C., Lanovaz, J., Oates, A., Craven, B., Butcher, S. (2014). The Effect of Adding Core Stability Training to a Standard Balance Exercise Program on Sit to Stand Performance in Older Adults: A Pilot Study. Journal of Aging and Physical Activity, 21. [Epub ahead of print] Azevedo, P.F.P. (2009). 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Bridge This chapter comprehends an article which reports the findings on the primary outcome of the main randomized controlled trial developed in the context of the present research. This article is entitled “The ProBalance Program improves balance and reduces fall risk in community-dwelling older adults from Madeira Island, Portugal: A randomized controlled trial”. This original research report argues whether this rehabilitation nursing intervention was effective in improving clinical balance of the older adults with balance impairments. The preliminary results of this study were presented in a slide communication in the American College of Sports Medicine’s Annual Meeting and 5th World Congress on Exercise is Medicine® (May 27-31, 2014). An abstract was published on the leading multidisciplinary original research journal of the American College of Sports Medicine, namely, the Medicine and Science in Sports and Exercise (Impact Factor 4.475). The final article is under review by co-authors for submission to the International Journal of Nursing Studies. 104 Table 6.1 Participants’ characteristics at baseline: sociodemographic, clinical, cognition, balance, functional fitness, physical activity and health-related quality of life. Variables CG (n =20) IG (n = 26) p Sociodemographic Gender (female) 22 (88.0%) 24 (88.9%) - Age (y) 74.06±4.60 73.15±4.57 0.511 Education (y) 4.05±2.52 4.15±2.29 0.885 Clinical Number of medications (n) 5.50±3.02 5.81±2.55 0.710 Number of falls in the past year (n) 0.45±0.60 0.54±0.86 0.687 Cognition Mini-Mental State (score) 26.45±3.10 27.38±2.25 0.242 Balance Total FAB scale (score) 26.95±2.67 27.58±2.77 0.444 Gait velocity at the preferred speed (m/sec) 1.16±0.25 1.28±0.17 0.073 Gait velocity at the maximum speed (m/sec) 1.53±0.34 1.67±0.21 0.110 Falls Efficacy Scale (score) 86.90±18.35 90.88±10.75 0.361 Functional fitness Chair stand test (n) 13.05±3.28 13.62±2.70 0.525 Arm curl test (n) 15.00±3.49 16.08±3.64 0.317 6-minute walk test (m) 455.36±97.72 490.62±65.73 0.151 Physical activity Household (score) 1.74±0.29 1.89±0.45 0.181 Sports (score) 1.33±1.48 1.07±1.97 0.625 Leisure time (score) 2.32±2.78 5.28±4.41 0.008 Total (score) 5.38±2.50 8.24±4.92 0.014 Health-related quality of life Sf-36 physical component (score) 190.71±56.69 220.76±62.47 0.099 Sf-36 mental component (score) 211.25±76.86 231.43±103.65 0.452 Total Sf-36 (score) 401.96±115.73 452.19±151.48 0.225 CG, control group; IG, intervention group; FAB, Fullerton Advanced Balance; †absolute and relative frequencies; ‡values are means and standard deviations. 105 Effect of the intervention Descriptive statistics for total FAB Scale scores at baseline and after the intervention are presented in Table 6.2. After 12 weeks (post-test), the change scores in the total FAB scale mean are 5.15 points in the IG and -1.45 points in the CG. Considering that a 1- point change in total FAB scale score is associated to a 8.0% change in fall risk (Hernandez & Rose, 2008), the change scores after the 12-week intervention represent a 41.2% decrease in fall risk for the IG. At the same time point, the CG presented an increase in fall risk by 11.6%. All participants were assessed 12 weeks after the terminus of the intervention – detraining period. Descriptive results for the follow up are presented in Table 6.3. The change scores are -1.88 and 0.75 points, for IG and CG, respectively. These change scores represent a 15.0% increase in fall risk for the IG and a 6.0% decrease in fall risk for the CG. In both, CG and IG, changes reached statistical significance. 106 Table 6.2 Findings on the outcome measure at baseline and after the intervention by group: control and intervention. Control group (n=20) Intervention group (n=26) Variable Pre-test Post-test ∆ score p Pre-test Post-test ∆ score p Total FAB scale score 26.95±2.67 25.50±3.36 -1.45±2.80 0.032 27.58±2.77 32.73±2.11 5.15±2.81 <0.0001 FAB, Fullerton Advanced Balance; ∆ score, change between pre- and post-test. Table 6.3 Findings on the outcome measure at baseline and after the intervention by group: control and intervention. Control group (n = 20) Intervention group (n = 26) Variable Post-test Follow up ∆ score p Post-test Follow up ∆ score p Total FAB scale score 25.50±3.36 26.25±3.89 0.75±2.99 0.276 32.73±2.11 30.85±3.18 -1.88±1.84 <0.0001 FAB, Fullerton Advanced Balance; ∆ score, change between post-test and follow up. 107 Effect size estimates A mixed between-within subjects analysis of variance was conducted to assess the impact of the intervention/control on participants’ total scores on the FAB Scale, across the three time periods (pre-test, post-test and 12-week follow-up). This analysis demonstrates the significant interaction between the group and time (Wilk’s Lambda = 0.41, F (2, 43) = 30.75, p < 0.001, Partial Eta Squared = 0.59). There was a statistically significant effect for time (Wilk’s Lambda = 0.69, F (2, 43) = 9.65, p <0.001, Partial Eta Squared = 0.31), with the both groups showing changes in the total FAB scale scores across the three time periods. The significant main effect comparing the two groups (F (1, 44) = 29.43, p <0.001, Partial Eta Squared = 0.40) and the graphic representation (Figure 6.2) shows that there was a difference in the efficacy of the intervention and usual care (CG). In addition, the results show a very large effect size, assuming the guidelines proposed by Cohen (1988). Figure 6.2 Graphic representation of the results from the mixed between-within subjects analysis of variance (group vs time), showing the change in FAB scale total scores over time for the IG and CG. Discussion The general aim of this study was to examine the effect of the Probalance program in a clinical measure of balance in community-dwelling older adults. Two similar groups were evaluated in this RCT. The group that was randomly allocated to the 12-week intervention showed significant gains in balance after the intervention, contrary to their peers that were randomly allocated to the CG. After the intervention (post-test), the total FAB scale mean score increased by 5.15 points in the IG, while there was a decrease of 1.45 points in the CG. At follow up, the change scores were -1.88 and 0.75 points, for IG and CG, respectively. Besides there was a decrease in the IG, results did not reach the baseline scores. Overall, both groups showed changes in the total FAB scale scores across the 108 three time periods; nevertheless opposite results were found for the IG and CG (as seen in figure 2), which is explained by the significant interaction between the group and time, the significant effect of time, and the significant main effect comparing the two groups. Similarly, Westlake and Culham (2007), in a randomized controlled trial aimed to assess the effect of an 8-week theory-driven exercise intervention based on the FallProof Program, found post-intervention improvements in the FAB scale score (a 4-points increase for the IG and a 1-point increase for CG, which received education only). Contrary to our results, Westlake and Culham (2007) report the maintenance of FAB Scale scores by the participants in the IG at follow up. In regard to the increase FAB scale scores in the CG at follow-up, a similar finding was also reported by Westlake and Culham (2007) after the intervention. A possible explanation for these results could be a training effect after repeated assessments using the FAB Scale, as well as, an increased awareness of the participants in relation to balance and fall prevention. Although different measures of balance were used as outcome in the majority of randomized trials reviewed, multiple exercise type interventions have been shown to be associated to significant improvements in other composite measures of balance (Howe et al., 2011). Change score of 17.80 for the IG (n = 21) and 0.40 for the CG (n = 23) in the Berg Balance Scale (BBS) were found by Worm et al. (2001), after a 12-week intervention. Other studies, also using the also the BBS as an outcome measure, reported significant improvements in mean differences between control and intervention after immediately intervention (Beyer et al., 2007; Sykes & Ling, 2004). Another interesting finding of this study was that the total FAB scale mean score increased and moved away from the cut-off point of 25 in the IG, which was predictive of the faller status, as described by Hernandez and Rose (2008). On the other hand, after 12 weeks, the participants in the CG continued to present FAB scores equal or lower than 25 points. Another valuable finding is that, although there was a decrease at follow up for the IG, the total FAB scale score did not reach the baseline situation. These findings highlight the clinical significance of the effect of the ProBalance intervention, namely through its contribution to reduce fall risk. The statistical significance of the effect of the intervention demonstrated responsiveness to training in the participants in the IG; however, there was evidence of a short-lasting effect after the exercise intervention finished. The current study added evidence to support the conclusion stated by Howe et al. (2011) who observed that positive balance effects were only evident while engaging in the intervention. 109 Strengths There is previous evidence that exercise interventions can improve balance in communitydwelling older adults. Yet, the majority of previous research has targeted healthy older adults or frail older adults (Howe et al., 2011). The results of this study provide evidence to the existing research on the effects of group based exercise interventions targeting a balance-screened group of community-dwelling older adults. From a rehabilitation nursing perspective, early identification of balance impairments and delivery of specific training are important preventive interventions, since many older adults only seek health professional advice when serious fall-related injuries happen. Therefore, assessment and intervention at an early stage may prevent community-dwelling older adults from progressing to more severe impairments or experiencing a serious fall (Yang et al., 2012). Besides exercise programs that target the intrinsic risk factors associated with increased fall risk have been shown to be effective in a number of randomized controlled trials conducted over the past two decades (Rose, 2011). The present study aimed to respond to the need for research on theory-driven rehabilitation programs that focus on manipulating individual, task, and environmental constraints concurrently, as suggested by Rose and Clark (2000). Other advantage of our study was the high adherence to the sessions in the participants who completed the study (100%). This may be indicative of the high acceptability and motivation of the participants, related to this innovative intervention. Limitations Three limitations of this study should be addressed. First, balance was assessed using an indirect method; however, in opposition to direct measures of balance, such as force platform assessments; FAB does not require expensive equipment and are easily reproduced in community settings (Howe et al., 2011). Since the present research has focused on assessing balance in independent community-dwelling older adults and that it was desirable a valid and reliable field method, FAB was chosen as the main outcome. FAB scale is a relatively new multidimensional balance assessment tool that is designed to assess balance of higher functioning older adults. It was primarily developed by Debra Rose at California State University, Fullerton (Rose, Lucchese, & Wiersma, 2006), and has been shown to have good psychometric properties (Klein, Fiedler, and Rose, 2010). Second, participants were volunteers who responded to advertisement, which may limit the generalizability to the wider population. Finally, and besides other balance measures have been assessed in the ProBalance project, this study only reported the total FAB score. Further research will be conducted in order to fulfill these requirements. 110 Future directions The ProBalance program has been shown to produce an expected positive effect on balance under the circumstances of an RCT. However, the program’s long-term efficacy, its effectiveness in “real world” clinical settings, and its cost-effectiveness remain to be evaluated. Consequently, further research is needed to accomplish these goals. Conclusions This study demonstrated that ProBalance exercise program was effective in improving balance and reducing fall risk by 40% in a group of older adults with balance impairment, immediately after the intervention. The large effect size found indicated that the improvements could be attributed to the intervention. Future research should focus on long term-efficacy and include pragmatic trials to assess the effectiveness and costeffectiveness of this intervention in “real world” clinical settings. References Azevedo, P.F.P. (2009). Estudo para a validação do questionário de Baecke modificado por acelerometria, na avaliação da actividade física em idosos portugueses (Master’s Thesis). Retrieved from U.Porto's Open Repository (12903). Beyer, N., Simonsen, L., Bülow, J., Lorenzen, T., Jensen, D.V., Larsen, L., … Kjær, M. (2007). Old women with a recent fall history show improved muscle strength and function sustained for six months after finishing training. Aging Clinical and Experimental Research, 19(4), 300-309. Cohen, J. (1988). Statistical power analysis for behavioral sciences (2nd Ed.). Hillsdale: Lawrence Erlbaum Associates Publishers. Deandrea, S., Lucenteforte, E., Bravi, F., Foschi, R., La Vecchia, C., & Negri, E. (2010). Risk Factors for Falls in Community-dwelling Older People: A Systematic Review and Meta-analysis. Epidemiology, 21(5), 658-668. Faul, F., Erdfelder, E., Lang, A-G., & Buchner, A. (2007). G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavioral Research Methods, 39, 175–191. Folstein, M.F., Folstein, S.E., & McHugh, P.R. (1975). “ Mini-Mental State”: A practical method for grading the cognitive state of patients for the clinician. Journal of Psychiatric Research, 12(3), 189-198. 111 Graffar, M. (1956). Une méthode de classification sociale d’échantillons de population. Courier, 6, 455-459. Guerreiro, M., Silva, A.P., Botelho, A., Leitão, O., Castro-Caldas, A., & Garcia, C. (1994). Adaptação à população portuguesa da tradução do Mini Mental State Examination (MMSE). Revista Portuguesa de Neurologia, 1, 9. Hernandez, D. & Rose, D.J. (2008). Predicting which older adults will or will not fall using the Fullerton Advanced Balance Scale. Archives of Physical Medicine Rehabilitation, 89, 2309-2315. Howe, T.E., Rochester, L., Neil, F., Skelton, D. A. & Ballinger, C. (2011). Exercise for improving balance in older people. Cochrane Database of Systematic Reviews, 11, Art. No.: CD004963. Klein, P.J., Fiedler, R.C., & Rose, D.J. (2010). Rasch analysis of the Fullerton Advanced Balance (FAB) Scale. Physiotherapy Canada, 63(1), 115-125. Muir, S.W., Berg, K., Chesworth, B., Klar, N., & Speechley, M. (2010). Modifiable Risk Factors Identify People Who Transition from Non-fallers to Fallers in Community- Dwelling Older Adults. Physiotherapy Canada, 62(4). 358-367. Ribeiro, J. P (2005). O importante é a saúde: estudo de adaptação de uma técnica de avaliação do estado de saúde- SF- 36. Lisboa: Merck Sharp & Dolme. Rikli, R.E., & Jones, J. (2001). Senior fitness test manual. Development and validation of a functional fitness test for community-residing older adults. Champaign, IL: Human Kinetics. Rose, D.J, Lucchese, N., & Wiersma, L.D. (2006). Development of a multidimensional balance scale for use with functionally independent older adults. Archives of Physical Medicine Rehabilitation, 87, 1478-1485. Rose, D.J. (2003). FallProof! A comprehensive balance and mobility training program. Champaign: Human Kinetics. Rose, D.J. (2010). FallProof! A comprehensive balance and mobility training program (2nd Ed.). Champaign: Human Kinetics. Rose, D.J. (2011). Reducing the Risk of Falls Among Older Adults: The Fallproof Balance and Mobility Program. Current Sports Medicine Reports, 10(3), 151-156. Rose, D.J., & Clark, S. (2000). Can the control of bodily orientation be significantly improved in a group of older adults with a history of falls?. Journal of the American Geriatric Society, 48(3), 275-282. 112 Rubenstein, L.Z., & Josephson, K.R. (2002). The epidemiology of falls and syncope. Clinical Geriatric Medicine, 18, 141-158. Sykes, K., & Ling, W.M. (2004). Exercise training and fall-risk prevention for communitydwelling elders. American Journal of Recreation Therapy, 3(2), 36-42. Tinetti, M. A., Richman, D., & Powell, L. (1990). Falls Efficacy As A Measure Of Fear Of Falling, Journal of Gerontology, 45(6), 239-243. Tinetti, M.E., & Kumar, C. (2010). The patient who falls “It’s always a trade-off”. Journal of the American Medical Association, 303(3), 258-266. Voorrips, L.E., Ravelli, A.C.J., Dongelmans, P.C.A., Deurenberg, P., & Staveren, W.A.V. (1991). A physical activity questionnaire for the elderly. Medicine and Science in Sports and Exercise, 23(8), 974-979. Ware, J. E., & Sherbourne, C. D. (1992). The MOS 36-item short-form health survey (SF- 36). Medical Care, 30(6), 473-483. Worm, C.H., Vad, E., Puggard, L., Stovring, H., Lauritsen, J., & Kragstrup, J. (2001). Effects of a multicomponent exercise program on functional ability in communitydwelling, frail older adults, Journal of Aging and Physical Activity, 9(4), 414-424. Yang, X.J., Hill, K., Moore, K., Williams, S., Dowson, L., Borschmann, K., …, Dharmage, S.C. (2012). Effectiveness of a targeted exercise intervention in reversing older people’s mild balance dysfunction: a randomized controlled trial. Physical Therapy, 92(1), 24-37. 113 Chapter 7 The effect of the ProBalance Program in strength and gait of community-dwelling older adults from Madeira Island, Portugal: A randomized controlled trial. Bridge This chapter comprehends an article reporting the effects of the ProBalance intervention in major balance-related outcomes. The article is entitled “The effect of the ProBalance Program in strength and gait of community-dwelling older adults from Madeira Island, Portugal: A randomized controlled trial”. This original report addresses the efficacy of this rehabilitation nursing intervention in improving strength of the lower and upper body, gait velocity, stride length and cadence in older adults with balance impairments, in the context of the ProBalance main randomized controlled trial. This article is under review by co-authors for submission to the Journal of the American Geriatrics Society. 120 time) there were statistically significant differences between the IG and the CG at baseline. Participants in the IG show higher scores than their peers from the CG. Table 7.1 Participants’ characteristics at baseline: sociodemographic and clinical characteristics, cognition, balance, functional fitness, physical activity and health-related quality of life. Variables CG (n =20) IG (n = 26) p Sociodemographic Gender (female) 90.00% 88.50% - Age (y) 74.06±4.60 73.15±4.57 0.511 Education (y) 4.05±2.52 4.15±2.29 0.885 Clinical Number of medications (n) 5.50±3.02 5.81±2.55 0.710 Number of falls in the past year (n) 0.45±0.61 0.54±0.86 0.697 Cognition Mini-Mental State (score) 26.45±3.16 27.38±2.25 0.242 Balance Total FAB scale (score) 26.95±2.67 27.58±2.77 0.444 Gait velocity at the preferred speed (m/sec) 1.16±0.24 1.28±0.17 0.090 Gait velocity at the maximum speed (m/sec) 1.53±0.34 1.67±0.21 0.110 Stride length at preferred speed (m/stride) 1,17±0,18 1,26±0,13 0.050* Stride length at maximum speed (m/stride) 1,34±0,19 1,48±0,14 0.005* Cadence at preferred speed (steps/sec) 1,98±0,19 2.02±0,18 0.432 Cadence at maximum speed (steps/sec) 2.27±0,28 2.26±0,20 0.880 Falls Efficacy Scale (score) 86.90±18.35 90.88±10.75 0.361 Functional fitness Chair stand test (n) 13.05±3.28 13.62±2.70 0.525 Arm curl test (n) 15.00±3.50 16.08±3.64 0.317 6-minute walk test (m) 455.36±97.72 490.62±65.73 0.151 Height (cm) 153.89±6.34 152.98±7.07 0.653 Weight (kg) 71.06±11.91 65.87±12.82 0.168 Physical activity Household (score) 1.74±0.29 1.89±0.45 0.181 Sports (score) 1.33±1.48 1.07±1.97 0.625 Leisure time (score) 2.31±2.78 5.27±4.41 0.008* Total (score) 5.38±2.50 8.24±4.92 0.014* Health-related quality of life Sf-36 physical component (score) 190.71±56.69 220.76±62.47 0.099 Sf-36 mental component (score) 211.25±76.86 231.43±103.65 0.452 Sf-36 total (score) 401.96±115.73 452.19±151.48 0.225 Values are mean±standard deviation for quantitative variables and relative frequencies (%) for qualitative variables. FAB, Fullerton Advanced Balance. 121 Description of effects Descriptive statistics for the strength tests and gait parameters at preferred and maximal speed at pre-test and post-test are presented in table 7.2. After 12-weeks (post-test), the mean change score in the chair stand test was 0.25 in the CG and 2.42 in the IG. Similar results were seen in the arm curl test, with a mean change score of 0.20 in the CG and 2.23 in the IG. In both strength tests, only in the IG, the improvements reached statistical significance. In gait parameters at preferred speed similar changes were seen in both the CG and the IG. Overall, no significant changes were found. In gait parameters at maximal speed, statistically significant changes were seen in gait velocity and cadence, only for the IG. For gait velocity, the mean change score was 0.07 in the CG and 0.21 in the IG; while for cadence, the change score was -0.07 in the CG and 0.22 in the IG. Participants were also assessed 12 weeks after the terminus of the intervention (follow up). Descriptive results for the follow up are presented in table 7.3. After the 12-week follow up, changes were seen in both groups in the strength tests. In the chair stand test, the mean change score was 0.55 in the CG and -1.15 in the IG. For the arm curl test, the mean change score was 0.60 in the CG and -1.73 in the IG. In both strength tests, only in the IG, changes reached statistical significance, describing a significant decrease in the lower and upper body strength with detraining. In gait parameters at preferred speed and at maximal speed, modest or no changes were seen in both the CG and the IG, however, in both groups, changes did not reach statistical significance. 122 Table 7.2 Findings on the outcome measures at baseline and after the intervention by group. Control Group (n = 20) Intervention Group (n = 26) Variables Pre-test Post-test ∆ score p Pre-test Post-test ∆ score p Strength Chair stand test (n) 13.05±3.14 13.30±3.61 0.25±1.68 0.514 13.41±2.86 16.04±2.55 2.42±1.70 <0.001 Arm curl test (n) 15.00±3.40 15.20±5.04 0.20±2.91 0.762 16.00±3.59 18.31±2.33 2.23±2.55 <0.001 Gait at preferred speed† Velocity (m/sec) 1.16±0.25 1.24±0.20 0.08±0.19 0.075 1.28±0.17 1.33±0.13 0.06±0.21 0.164 Stride length (m/stride) 1.16±0.18 1.22±0.13 0.05±0.12 0.062 1.25±0.14 1.29±0.11 0.03±0.13 0.207 Cadence (Steps/sec) 1.98±0.19 2.04±0.20 0.06±0.20 0.222 2.03±0.18 2.07±0.13 0.04±0.18 0.268 Gait at maximal speed† Velocity (m/sec) 1.53±0.34 1.60±0.33 0.07±0.22 0.171 1.67±0.21 1.88±0.21 0.21±0.20 <0.001 Stride length (m/stride) 1.33±0.18 1.49±0.39 0.15±0.42 0.130 1.48±0.14 1.53±0.14 0.04±0.12 0.082 Cadence (Steps/sec) 2.27±0.28 2.19±0.35 -0.07±0.34 0.355 2.26±0.20 2.47±0.23 0.22±0.32 0.002 Values are means and standard deviations; †Walk a distance of 15 meters; ∆ score, change between pre- and post-test. 123 Table 7.3 Findings on the outcome measures after the intervention and at follow up by group. Control Group (n = 20) Intervention Group (n = 26) Variables Post-test Follow up ∆ score p Post-test Follow up ∆ score p Strength Chair stand test (n) 13.30±3.61 13.85±2.60 0.55±2.19 0.275 16.04±2.55 14.88±1.77 -1.15±1.76 0.003 Arm curl test (n) 15.20±5.04 15.80±3.56 0.60±2.74 0.340 18.31±2.33 16.58±2.35 -1.73±1.97 <0.001 Gait at preferred speed† Velocity (m/sec) 1.24±0.20 1.26±0.20 0.01±0.15 0.730 1.33±0.13 1.33±0.16 0.00±0.15 0.866 Stride length (m/stride) 1.22±0.13 1.23±0.13 0.01±0.09 0.668 1.29±0.11 1.29±0.08 0.00±0.10 0.992 Cadence (Steps/sec) 2.04±0.20 2.04±0.18 0.00±0.19 0.969 2.07±0.13 2.06±0.17 -0.01±0.18 0.716 Gait at maximal speed† Velocity (m/sec) 1.60±0.33 1.58±0.27 -0.02±0.20 0.702 1.88±0.21 1.83±0.22 -0.05±0.17 0.166 Stride length (m/stride) 1.49±0.39 1.41±0.21 -0.08±0.41 0.396 1.53±0.14 1.52±0.12 0.00±0.11 0.899 Cadence (Steps/sec) 2.19±0.35 2.24±0.18 0.05±0.34 0.519 2.47±0.23 2.41±0.27 -0.06±0.27 0.273 Values are means and standard deviations; †Walk a distance of 15 meters; ∆ score, change between post-test and follow up. 124 Effect size estimates A mixed between-within subjects analysis of variance was conducted to assess the impact of the intervention/control on all outcome measures, across the three time periods (pretest, post-test and 12-week follow-up), controlling for PA and age. In the chair stand test, this analysis demonstrates that there was a significant interaction between the group and time (Wilk’s Lambda = 0.70, F (2, 41) = 8.75, p = 0.001, Partial Eta Squared = 0.30), with the both groups showing improvements over time. No statistically significant main effects were found for time (Wilk’s Lambda = 0.97, F (2, 41) = 0.66, p = 0.52, Partial Eta Squared = 0.03) or for group (F (1, 42) = 1.20, p = 0.28, Partial Eta Squared = 0.03) in this balance-related outcome. In the arm curl test, results from the mixed-ANOVA showed also that there was a significant interaction between the group and time (Wilk’s Lambda = 0.79, F (2, 41) = 5.57, p = 0.007, Partial Eta Squared = 0.21), with the both groups showing improvements in the upper body strength. Again, no significant main effects were found for time (Wilk’s Lambda = 0.92, F (2, 41) = 1.72, p = 0.19, Partial Eta Squared = 0.08) or group (F (1, 42) = 0.87, p = 0.36, Partial Eta Squared = 0.02) in the arm curl test. A graphic representation of the mixed between-within subjects analysis of variance (group vs time, with PA and age as covariates) is shown in Figure 7.2 for chair stand (a) and arm curl test (b). Figure 7.2 Graphic representation of the results from the mixed between-within subjects analysis of variance (group vs time, with PA and age as covariates), showing the change in the chair stand (a) and arm curl tests (b), over time for the CG and IG. For gait parameters at preferred speed, the same analysis demonstrates that there were no significant main effects. At maximal speed, results show that there were significant effects in gait velocity and cadence. In gait velocity, there was no significant interaction 125 between the group and time (Wilk’s Lambda = 0.87, F (2, 40) = 2.91, p = 0.06, Partial Eta Squared = 0.13) nor a significant effect for time (Wilk’s Lambda = 0.99, F (2, 40) = 0.19, p = 0.82, Partial Eta Squared = 0.01). In opposition, there was a significant main effect comparing the two groups (F (1, 41) = 6.45, p = 0.02, Partial Eta Squared = 0.14), suggesting that there was large effect size. In cadence, there was a significant and large interaction effect between the group and time (Wilk’s Lambda = 0.82, F (2, 40) = 4.53, p = 0.02, Partial Eta Squared = 0.19). However, there was no statistically significant effect for time (Wilk’s Lambda = 0.95, F (2, 40) = 1.09, p = 0.34, Partial Eta Squared = 0.05) and no significant effect for group (F (1, 41) = 3.86, p = 0.06, Partial Eta Squared = 0.09). The graphic representation of these results is shown in figure 7.3. Figure 7.3 Graphic representation of the results from the mixed between-within subjects analysis of variance (group vs time, with PA and age as covariates), showing the change in cadence at maximal speed, over time for the CG and IG. Discussion The purpose of this study was to examine the effect of the ProBalance program in a set of balance-related outcomes, namely, strength and gait in a group of community-dwelling older adults screened for balance impairments. Two similar groups were assessed in this RCT, in a total of three assessments (pre-test, post-test and follow up). While no significant differences were seen in the CG across the three time points, the IG showed significant improvements in the strength of the lower and upper body, immediately after the 12-week intervention. Furthermore, the IG experienced a significant decrease in strength after follow up. In regard to gait parameters at preferred speed, no significant differences or effects were seen. Yet, at maximal speed, our results showed that there were significant differences in gait velocity and cadence in the IG. These results are in agreement to those of previous research on the effect of different interventions on balance-related outcomes, showing that multiple exercise type interventions were associated to significant improvements in strength and gait (Cadore, 126 Rodríguez-Mañas, Sinclair, & Izquierdo, 2013; Howe et al., 2011), however, inconsistent research findings on the effect of exercise on gait of community-dwelling older adults have been described (Lopopolo, Greco, Sullivan, Craik, & Mangione, 2006). Binns and Taylor (2011) have developed a 24-week duration controlled trial focused on the effect of an exercise program targeting strength and balance (the Otago Exercise Program) in older adults (n=37), delivered by nurses in a community care setting. Only pre- and post-test assessments were considered in this study and outcomes included lower body strength, assess by the chair stand test, and mobility, assessed by gait velocity at maximal speed. Contrary to our results, this research found no improvements in lower body strength (change score = 0.00) in the IG, while modest improvements were seen in the CG (change score = 0.35). In regard to gait velocity, Binns and Taylor (2011) found negative change scores for both groups (-0.16 in the IG and -0.06 in the CG). Nevertheless, changes did not reach statistical significance. Hartmann, Murer, Bie and de Bruin (2009) have also investigated the effect of physical exercise combined with foot gymnastics on strength and gait performance in older adults (n=56), in the context of an RCT. Although using different instruments, similarly to our results, in this study there were significant increases in lower body muscle power, gait velocity and cadence in stable floor. These results parallel our findings. On the other hand, Hartmann et al. (2009) found significant improvements in step length, which was not verified in the current research. Halvarsson, Olsson, Farén, Pettersson and Stahle (2011) also found significant positive changes in gait velocity and cadence at maximal speed after group-based balance training program. In this research, significant changes in cadence at preferred speed were also seen. Independent of the type of interventions and instruments used, while some RCTs have failed to find significant differences in strength (Bird, Hill, & Fell, 2012) and gait velocity (Barnett et al, 2003) after the exercise intervention, others showed significant improvements on the studied variables, supporting our results (Beyer et al., 2007; Behpoor, Darabi, Hojatoleslami, Bayat, & Ghanbari, 2012; Granacher et al., 2012). In regard to strength, our results demonstrate that the effects of the ProBalance intervention on strength were short-lasting, since significant decreases in the lower and upper body were seen after the exercise intervention ceased. In face of evidence of these short-lasting effects of exercise, the current study adds evidence to support the recommendation that muscle-strengthening activities involving major muscle groups, should be performed by older adults on 2 or more days a week, in addition to the recommended 150 minutes of moderate-intensity aerobic physical activity per week or 75 minutes of vigorous-intensity aerobic physical activity throughout the same time period (WHO, 2010). 127 In the present research, the CG did not show significant deterioration of any of the outcome measures during the trial. Binns and Taylor (2011), suggest that 24-weeks may be an insufficient period of time to observe the manifestations of physiological age-related changes. Nevertheless, Hartmann et al. (2009) have found a deterioration trend in strength and gait after 12-weeks. A possible explanation for this result could be the effect of PA and age, which have been controlled for in our analysis. Strengths There is evidence that exercise interventions can improve balance-related outcomes in community-dwelling older adults. However, while most studies have targeted healthy or frail older adults (Howe et al., 2011), this study adds evidence on the effects of multiple type exercise interventions targeting a balance-screened group of community-dwelling older adults. An advantage of this prehabilitation approach, including assessment and intervention at an early stage, could be preventing community-dwelling older adults from progressing to more severe impairments or experiencing a serious fall as suggested by Yang et al. (2012). Besides many types of exercise programs have been shown to effectively improve balance of older adults in several randomized controlled trials conducted in the last decades (Howe et al., 2011), the need for further research on the effect of theory-driven rehabilitation programs that focus on the concurrent manipulation of individual, task-related, and environmental constraints has been reported (Rose & Clark, 2000). In response to this need, this study adds evidence on the beneficial effect of a theory-driven intervention targeting balance and mobility of older adults, based in the FallProof Program (Rose, 2010). Easy reproducibility of the assessments in clinical practice was also desired. To grant this requirement, functional performance-based tests were used as outcome measures in our study. Although they are not direct measures of strength or balance, functional measures are typically used in older adults as they better relate to performance in activities of daily living (Binns & Taylor, 2011), do not require expensive equipment and are easily reproduced in community settings (Howe et al., 2011). Other advantage of our study was the very high adherence of the participants to the intervention and the inexistence of adverse events related to the participation in the intervention, suggesting that the program was motivating and safe for the participants. Limitations Three limitations of this study should be stated. First, the participants in our study were volunteers who responded to advertisement, which can limit the generalizability of the results. Second, in spite of the randomization, there were differences in baseline 128 characteristics of the participants. In order to overcome this weakness, PA entered as covariate in the statistical.Third, other balance-related outcomes could be useful to better understand the effects of this complex intervention, however, besides other core outcome measures have been assessed in the ProBalance project, part of these data have been reported elsewhere (Gouveia et al., 2014). Future directions The ProBalance program has been shown to produce improvements in strength, and gait velocity and cadence at maximal speed, under the circumstances of a small scale RCT. Still, research is needed on the program’s long-term efficacy, its effectiveness at the community level, and its cost-effectiveness. Further research will be conducted in order to fulfill these requirements. Conclusions The results of the present study showed that the participation in the 12-week rehabilitation nursing program – the ProBalance program was associated to improvements in strength, gait velocity and cadence at maximal speed. Short-lasting effects on strength were verified at follow-up, with significant decreases in the scores of strength tests. Overall, the large effect sizes suggest that the improvements could be attributed to the intervention. This study adds evidence to previous research on the effect of an exercise intervention on balance-related outcomes, supporting the known evidence that multiple exercise type interventions are associated to significant improvements in strength and gait. However, further research should target a longer intervention period, its long term-efficacy and proceed to pragmatic trials to assess the effectiveness and cost-effectiveness of this intervention in clinical settings. References Azevedo, P.F.P. (2009). Estudo para a validação do questionário de Baecke modificado por acelerometria, na avaliação da actividade física em idosos portugueses (Master’s Thesis). Retrieved from U.Porto's Open Repository (12903). Barnett, A., Smith, B., Lord, S.R., Williams, M., & Baumand, A. (2003). Community-based group exercise improves balance and reduces falls in at-risk older people: A randomised controlled trial. Age Ageing, 32(4), 407-414. Behpoor, L., Darabi, M.R., Hojatoleslami, L., Bayat, P-D. & Ghanbari, A. (2012). The effect of a group exercise program on muscular function among fall-prone elderly women. International Journal of Morphology, 30(2), 567-571. 129 Beyer, N., Simonsen, L., Bülow, J., Lorenzen, T., Jensen, D.V., Larsen, L., …, Kjær, M. (2007). Old women with a recent fall history show improved muscle strength and function sustained for six months after finishing training. Aging Clinical and Experimental Research, 19(4), 300-309. Binns, E., & Taylor, D. (2011). The effect of the Otago exercise programme on strength and balance of community dwelling older women. New Zealand Journal of Physiotherapy, 39(2), 63-68. Bird, M.L., Hill, K.D., & Fell, J.W. (2012). A randomized controlled study investigating static and dynamic balance in older adults after training with Pilates. Archives of Physical Medicine and Rehabilitation, 93(1), 43-49. Cadore, E.L., Rodríguez-Mañas, L., Sinclair, A. & Izquierdo, M. (2013). Effects of different exercise interventions on risk of falls, gait ability, and balance in physically frail older adults: A systematic review. Rejuvenation research,16(2), 105-114. Cohen, J. (1988). Statistical power analysis for behavioral sciences (2nd Ed.). Hillsdale: Lawrence Erlbaum Associates Publishers. Deandrea, S., Lucenteforte, E., Bravi, F., Foschi, R., La Vecchia, C., & Negri, E. (2010). Risk factors for falls in community-dwelling older people: A systematic review and meta-analysis. Epidemiology, 21(5), 658-668. Faul, F., Erdfelder, E., Lang, A-G., & Buchner, A. (2007). G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavioral Research Methods, 39, 175-191. Folstein, M.F., Folstein, S.E., & McHugh, P.R. (1975). “ Mini-Mental State”: A practical method for grading the cognitive state of patients for the clinician. Journal of Psychiatric Research, 12(3), 189-198. Gouveia, BR; Jardim, H; Martins, MM; Gouveia, ER., Freitas, DL., Maia, JA., Rose, DJ. (2014). Impact of the ProBalance program on balance in community-dwelling older adults from Madeira Island, Portugal. Medicine & Science in Sports & Exercise, 46(5) [S105], 105. Granacher, U., Muehlbaue, T., Bridenbaugh, S.A., Wolf, M., Roth, R. Gschwind, Y., Wolf, I., Mata, R., & Kressig, R.W. (2012). Effects of a salsa dance training on balance and strength performance in older adults. Gerontology, 58(4), 305-312. 136 In the same sample 177 older adults, 52 were randomized to two similar groups and were evaluated and considered in a per protocol analysis (n=46). No significant differences were seen in the CG across the two time points (pre- and posttest) for strength and gait. The IG showed significant improvements in the strength of the lower body, with a change score of 2.42 (SD = 1.70), and the upper body, with a change score of 2.23 (SD = 2.55), immediately after the 12-week intervention. At follow-up, there was a decrease in both lower and upper body strength, with change scores of -1.15 (SD = 1.76) and -1.73 (SD = 1.97), respectively. The mixed-ANOVA, controlling for physical activity and age, showed a large interaction effect between group and time for chair stand and arm curl tests. No statistically significant differences were seen for gait parameters at preferred speed, for both groups. At maximal speed, there were significant differences and a large effect size for group in gait velocity in the IG (change score = 0.21, SD = 0.20) and large interaction effects in cadence (change score = 0.22, SD = 0.312). This study highlighted the efficacy of the ProBalance program on strength and gait, namely, since it was associated to significant improvements in strength of the lower and upper body; and gait velocity and cadence at maximal speed. Overall, this research succeeded in demonstrating that the ProBalance Program, a multidimensional rehabilitation nursing intervention, was feasibility and safe for community-dwelling older adults from Madeira, Portugal, in the context of a pilot RCT. Also the efficacy of this intervention was confirmed in the context of a larger RCT, namely in regard to balance and fall risk and other balance-related outcomes assessed. Based on the findings from hypothesis testing, we can state that all hypotheses were verified. Therefore, the following conclusions can be derived from the results: (1) The group of community-dwelling older adults involved in ProBalance program had significantly higher levels of balance and lower risk for falling when compared with the group that did not receive the ProBalance intervention, after a 12 week duration intervention and 12 week follow up (H1); (2) The group of community-dwelling older adults involved in ProBalance program had higher levels of muscular strength (lower body and upper body) when compared with the group that did not receive the ProBalance intervention, after a 12 week duration intervention and 12 week follow up (H2); (3) The group of community-dwelling older adults involved in the ProBalance program had better results in gait parameters when compared with the group who did not receive ProBalance intervention, after a 12 week duration intervention and 12 week follow up (H3). 137 8.2. Limitations and strengths of the research This research comprised two studies. First, a small scale pilot RCT was developed to test feasibility of the ProBalance program and allow the modelling of the research. The main RCT followed this research, integrating the knowledge drawn from this first study. Awareness of the limitations of this research is important for an adequate interpretation of our study findings. Therefore, four main limitations in this research should be addressed: (1) the participants in both studies were volunteers who responded to advertisement, which can limit the generalizability of the results; (2) although balance-related outcomes were assessed using valid and reliable instruments, it consisted in indirect methods of assessment, which limit the comprehension and generalizability of results; (3) the reduced the time of intervention and the short term follow up could have limited the magnitude of the effects of the ProBalance detected in this research; and (4) although this study aimed primarily to assess efficacy of an intervention, a per protocol analysis might potentiate the results. Besides these limitations, several strengths are to be mentioned: (1) the methodological quality of the research. The research process and methodological options followed the Medical Research Council guidance for the development, evaluation and implementation of complex interventions to improve health (MRC, 2008), and the CONSORT Statement (Boutron et al., 2008), as a guideline for reporting results from clinical trials; (2) both RCTs were prospectively registered; (3) assessment and intervention protocols turned out to be feasible; (4) inexistence of adverse events related to the participation in the intervention, ensuring safety of the intervention; (5) high test-retest reliability of the measurements was verified; (6) the assessors were trained professionals, including an expert in the field; (7) blinding was used in the randomization and assessment procedures; (8) the intervention was delivered by only one trained rehabilitation nurse, not involved in the assessments; (9) trained independent members of the intervention team kept security of the exercise in a 1:1 ratio; (10) easy reproducibility of the assessments and interventions were granted through the use of easily accessible and mobile materials; (11) high adherence and retention of the participants during the trials was achieved; and (12) the pertinence and clinical relevance of study findings. 8.3. Implications for clinical practice and future directions The ProBalance program has been shown to produce significant and clinically relevant improvements in balance, strength, and gait velocity and cadence at maximal speed, under the circumstances of a randomized controlled trial. Therefore, this research has contributed to increased knowledge on the effect of a nursing intervention designed to improve clinical balance of community-dwelling older adults with balance impairments. 138 This new knowledge is of great importance for nursing sciences, due to the impact in clinical nursing, as a rationale for nursing interventions in the care of older adults. Therefore, dissemination in scientific journals and technical literature is necessary. In face of evidence of the short-lasting effects of exercise found, the current study adds evidence to support recommendations that balance and muscle-strengthening activities should be performed by older adults in addition to general physical activity. Future research should focus on the long term-efficacy of the ProBalance intervention. In addition, pragmatic trials should be developed to assess the effectiveness and costeffectiveness of this intervention in “real world” clinical settings. Further research will be conducted in order to fulfill these requirements. 8.4. References Boutron, I., Moher, D., Altman, D.G., Schulz, K.F., Ravaud, P. & CONSORT Group. (2008). Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Annals of Internal Medicine, 148(4), 295-309. Deandrea, S., Lucenteforte, E., Bravi, F., Foschi, R., La Vecchia, C., Negri, E. (2010). Risk Factors for Falls in Community-dwelling Older People: A Systematic Review and Meta-analysis. Epidemiology, 21(5), 658-668. Halberg, I.R. (2006). Challenges for future nursing research: Providing evidence for health-care practice. International Journal of Nursing Studies, 43, 923-927. Miller, C.A. (2012). Nursing for wellness in older adults (6th Ed.). Philadelphia: Lippincott Williams & Wilkins. MRC [Medical Research Council]. (2008). Developing and evaluating complex interventions: new guidance. London: Medical Research Council. Rose, D.J. (2010). FallProof! A comprehensive balance and mobility training program (2nd Ed.). Champaign: Human Kinetics. Rubenstein, L.Z. & Josephson, K.R. (2002). The epidemiology of falls and syncope. Clinical Geriatric Medicine, 18, 141–158. Tinetti, M.E. & Kumar, C. (2010). The patient who falls “It’s always a trade-off”. Journal of the American Medical Association, 303(3), 258-266. 139 Appendices 140 Appendix I – Sample exercise session plan 141 ProBalance Program Prehabilitation and rehabilitation nursing: Balance and fall risk in community-dwelling older adults. Randomized controlled trial. Sample ProBalance Session First part Position Exercise - Repetitions Sitting. 1. Head turns and tilts - 5 repetitions each side. 2. Shoulder rotation - 5 repetitions. 3. Arm rotations - 5 repetitions. 4. Reach overhead - 5 repetitions. Uprigth position, walking. 5. Walking exercises:  Heel digs  Toe taps  Knee lifts - 5 repetitions each. Uprigth position, next to a chair. 6. V-steps - 5 repetitions. Uprigth position, chair in front. 7. Side steps with arm movements - 10 repetitions. Uprigth position, next to a chair. 8. Side lunges - 5 repetitions each side. 9. Double side step with:  Heel digs  Toe taps  Knee lifts - 4 repetitions each foot. 10. Cha Cha Cha steps - 4 repetitions each leading foot. 142 Second part Position Exercise - Repetitions Uprigth position, next to a chair. 11. Weigth shifts with head turns – 5 repetitions each side. 12. Forward steps on a bench - 5 repetitions each foot. Uprigth position. 13. Crossing over two parallel lines in the floor - 2 repetitions per participants. Third part Position Exercise - Repetitions Uprigth position. 14. Volley ball in a circle - 5 touches per participant, in stable surface and then over foam. Uprigth position, next to a chair. 15. Semi-tandem e Tandem over foam, tossing the ball with two hands - 5 repetitions each position. Uprigth position. 16. Walking with disturbed vision.  Passing the ball to another participants;  Identify images and say the name of fruits and vegetables.  Wear dark glasses. - 2 repetition per participants. Fourth part Position Exercise - repetitions Uprigth position, walking. 17. Parachute exercise, walking with:  Heel digs;  Toe taps;  Knee lifts;  Squats;  Switch places;  Two teams, moving bean bags from one side to another. – 5 repetitions each position. 143 Position Exercise - repetitions 18. Crossing the street at the visual and verbal signal. - 2 repetition per participants. Fifth part Position Exercise - repetitions Sitting. 19. Arm curl with theraband - 8 repetitions each side. 20. Arm extensions with theraband - 8 repetitions each side. 21. Chest press with theraband - 8 repetitions each side. Uprigth position, chair in front. 22. Heel raises - 5 sec, 8 repetitions each side. 23. Toe raises - 5 sec, 8 repetitions each side. Uprigth position, next to a chair. 24. Leg abduction - 5 sec, 8 repetitions each side. 25. Leg flexion and extension - 5 sec, 8 repetitions each side. Sixth part Position Exercise - repetitions Sitting. 26. Lateral shoulder stretch - 15 sec, 2 repetitions each side. 27. Reach over head - 15 sec, 2 repetitions. 28. Chin to chest - 15 sec, 2 repetitions. 29. Head turns - 15 sec, 2 repetitions. 30. Neck side stretch - 15 sec, 2 repetitions. 31. Trunk rotations - 15 sec, 2 repetitions. Upright, with a chair. 32. Hamstring stretch - 15 sec, 2 repetitions. Sitting 33. Calf stretch - 15 sec, 2 repetitions. 34. Foot rotation - 2 repetitions each foot. Materials: 1 Chair/ person; 1 Bench/ person; Foam Ball; 1 Foam/ person; 1 Pair of sunglasses/ person; Cards with images of fruits and vegetables; Rubber balls 10 cm diameter (1 per person); 1 Parachute; 20 Bean bags; 1 Theraband /person. 144 Appendix II – Educational session plan 145 ProBalance Program - Prehabilitation and rehabilitation nursing: Balance and fall risk in community-dwelling older adults. Randomized controlled trial. Educational Session Plan Theme: Fall prevention for older adults in the community Clients: Participants of the randomized controlled trial Duration: 45 minutes Objectives: (1) That participants learn about risk factors for falls in old age, consequences of falls in older adults and general fall prevention guidelines; (2) That the participants are motivated for take part in targeted exercise sessions, focused on fall risk reduction through balance training. Method: (1) Structured overview and debate. Contents: (1) Risk factos for falls in old age; (2) Consequences of falls in older adults; (3) General fall prevention guidelines; (4) Balance training and falls. References: CDC (2008). Preventing Falls: How to Develop Community-based Fall Prevention Programs for Older Adults. Atlanta: CDC. Darowski, Adam (2008). Falls: The facts. Oxford: Oxford University Press. Kauffman, T. (2007). Posture. In Kauffman, T.L.; Barr, J.O. & Moran, M.L. (Eds.), Geriatric rehabilitation manual (2ªEd) (pp. 99-105). Philadelphia: Elsevier. Lord, S. et al (2007). Falls in older people: risk factors and strategies for prevention (2ª Ed). Cambridge: Cambridge University Press. Miller, CA (2008). Nursing for wellness in older adults: Theory and practice (5th Ed). Philadelphia: Lippincott Williams & Wilkins.