The Effect of Proprioceptive Exercises on Balance and Physical Function in Institutionalized Older Adults: A Randomized Controlled Trial

1 The impact of proprioceptive exercises on balance and physical function in 1 institutionalized older adults: A randomized controlled trial 2 Abstract 3 Objective: The aim of this study was to evaluate the efficacy of a proprioceptive exercise 4 program on functional mobility, musculoskeletal endurance, dynamic and static balance, gait, 5 and risk of falls in institutionalized older adults. 6 Design: A randomized, single-blind, controlled trial. 7 Setting: A Spanish nursing home from the Autonomous Community of Extremadura, Spain. 8 Participants: An initial sample was created by recruiting 148 older adult volunteers. The 9 final sample (n = 42) was randomly divided into two groups. 10 Intervention: Both the control and experimental group received physical therapy treatment 11 based on a combination of adapted exercises and other physical therapy techniques (physical 12 therapy intervention program) for a period of 12 weeks. This program consisted of 45 minutes 13 (group intervention) plus 100 minutes (individual intervention) a week, for a total of 36 14 sessions (29 hours). The experimental group also received a proprioceptive training program 15 during the same intervention period, which was conducted twice weekly (24 sessions), each 16 session lasting 55 minutes. 17 Main Outcome Measures: The TUG, Cooper, Tinetti, One-Leg Stance and MORSE scales 18 were used. 19 Results: ANOVA analysis showed a time x group interaction in TUG scores (F=10.41, 20 P=.002), Cooper test (F=5.94, P=.019), Tinetti scores (F=6.41, P=.015) and MORSE scores 21 2 (F=5.24, P=.028). Differences between groups were achieved for TUG scores (d=0.76), 22 Tinetti scores (d=1.12), One-Leg Stance test scores (d=0.77) and MORSE scale scores 23 (d=0.85). In the experimental group, within-group analyses showed pre-post-treatment 24 differences for TUG scores (d=0.72), Cooper test scores in meters (d=0.18), Tinetti scores 25 (d=0.60), One-Leg Stance scores (d=0.55), and MORSE scores (d=0.42). 26 Conclusions: A proprioceptive exercise program produced significant improvements 27 compared to the control group in areas such as functional mobility, musculoskeletal 28 endurance, balance, gait, and risk of falls in institutionalized older adults. This study may help 29 to enhance our understanding of the impact of a specific protocol for a proprioceptive 30 rehabilitation program. 31 32 Key Words: 33 Proprioceptive; rehabilitation; physical activity; mobility; physical performance 34 35 List of abbreviations: 36 TUG Timed Up and Go test 37 SEM Standard Error of Measurement 38 MDC95 Minimum Detectable Change at the 95% confidence level 39 OLS One-Leg Stance test 40 3 Aging is defined as a natural process characterized by structural and functional changes that 41 can be accelerated by disease or other factors, such as inactivity.1 The worldwide population 42 is progressively aging and this is commonly associated with a deterioration of physical health, 43 functional performance and autonomy.2 Functional impairments may be associated with 44 alterations in balance and are an important predictive factor in various health conditions.3 45 About one-third of adults aged 65 years and over experiences a fall at least once a year.4 46 Moreover, people who have fallen once are at a higher risk of falling again, increasing the 47 healthcare costs of national health systems in several countries.5,6 Low levels of physical 48 exercise are associated with poor postural control, which is another major factor linked to an 49 increased risk of falling. Hence, physical decline in terms of balance, postural control and gait 50 typically lead to the institutionalization of older individuals, increasing demand for long-term 51 care.1-6 52 Health care centers belonging to private and public health systems usually provide 53 assistance to older adults in residential care facilities, hospitals or nursing homes.7 Long-term 54 residential care is increasingly demanded once the patient is discharged from hospital and 55 before they are able to return to a community setting.8 Therefore, prevention plans and health 56 promotion schemes for older adults have become increasingly important in recent decades, 57 while reducing age-related disability has become an essential public health goal.9 Previous 58 literature provides evidence of rehabilitation programs using therapeutic physical exercises in 59 the recovery process of common disorders in older people.10-11 Various therapeutic 60 approaches have shown their efficacy in improving health and functional movement in older 61 adults.6, 12-13 62 Proprioception is defined as “the perception of joint and body movement as well as 63 position of the body, or body segments, in space” 14 while kinesthetic sense is defined as “the 64 4 sense of position and movement of our limbs”.15 Although proprioception and kinesthesia are 65 involved in maintaining position, balance and movements when the eyes are both opened and 66 closed, these functions must be evaluated and trained with the eyes closed. Proprioceptive 67 exercises performed with the eyes closed reinforce the information sent and processed by the 68 central nervous system. The reception (on a sensory and perceptual level) and processing of 69 this information in older adults may be altered. If physical therapists stimulate these functions 70 through exercises with closed eyes and they actively direct attention toward body positions 71 and movements, the synaptic system that organizes this information at the neuronal level may 72 specifically be stimulated. In addition, these exercises likely integrate the proprioceptive 73 inputs with other balance components such as the vestibular system (the inner ear), the body 74 scheme (cognitive), base of support, body (trunk) symmetry, trunk sway, and the center of 75 gravity. In line with this, although proprioception is an essential aspect of balance, 76 proprioceptive exercises may specifically be used to improve proprioceptive and kinesthetic 77 integration in the brain, that is, the increase of synaptic connections for the perception of 78 static and dynamic positions in space.14,15 79 The lack of scientific evidence and conclusions on the efficacy of physical 80 rehabilitation on health variables has led to a wide variety of different experimental 81 protocols.6 For example, cardiovascular training or exercises to enhance strength, flexibility 82 and balance have been shown to significantly improve physical and mental health, as well as 83 having positive effects on various body functions.13,16 Nevertheless, to our knowledge, 84 research on the independent effects of proprioceptive exercises on functions such as general 85 mobility, balance, gait, or on the risk of falls in institutionalized older adults is still inadequate 86 to date. Findings in this specific area of rehabilitation are needed to provide clinical 87 5 knowledge for the appropriate design and planning of physical exercise interventions in this 88 population. 89 The main objective of this randomized controlled trial is to evaluate the efficacy of a 90 proprioceptive exercise program on functional mobility, musculoskeletal endurance, dynamic 91 and static balance, gait, and the risk of falls in comparison with a control group in 92 institutionalized older adults. 93 Methods 94 Design 95 This study is a randomized, single-blind, controlled trial. This trial was registered on 96 ClinicalTrials.gov (NCT number: 02541305). CONSORT statements were used to conduct 97 and report the trial. 98 Participants 99 An initial sample was created by recruiting 148 older adult volunteers from a Spanish nursing 100 home. Convenience sampling was used for recruitment (i.e. any participants that were 101 qualified for the trial were accepted). The final sample (n = 42) was randomly divided into 102 control and experimental groups, each comprising 21 participants. The control group (15 103 females, 6 males) only received a physical therapy intervention program. The experimental 104 group (14 females, 7 males) participated in the physical therapy program plus a 105 proprioceptive training program. Fig 1 depicts a flowchart of participant recruitment during 106 the study. 107 The inclusion criteria were: 1) adults over 65 years old, 2) living in an institutionalized 108 setting, 3) participating voluntarily in the study, 4) who had had a previous fall in the last year 109 (documented by the medical staff of the center in the twelve months before the inclusion of 110 6 the participant in the study), 5) physician’s prescription that the rehabilitation intervention 111 would be appropriate and potentially beneficial. The exclusion criteria were: 1) patients with 112 cognitive decline (score ≥24 in the official Spanish version of the Mini-Mental Status 113 Examination for older adults) 17 or those unable to understand or take part in the measurement 114 process, 2) patients unable to tolerate moderate physical activity due to cardio-vascular or 115 respiratory illness, 3) patients with disorders affecting balance different from those caused by 116 aging such as dizziness or vestibular disorders that require medication with a potential effect 117 on balance, as well as balance disorders secondary to taking any medication or other medical 118 causes, 4) patients with a high risk of falls (≥ 51 points on the MORSE scale). 119 The Ethics Research Committee from the University of Extremadura (Spain) approved 120 the study protocol (number: 17//2013). This protocol complied with all the principles of the 121 Declaration of Helsinki as amended in 2013. 122 Randomization 123 Participants were randomly allocated to the experimental or control groups. The 124 randomization was performed by asking the participant to pick a number out of an envelope. 125 A researcher, aware of the study design, conducted enrolment and group assignment. The 126 primary outcome measure was the Timed Up and Go (TUG) test. Participants from both 127 groups were assessed both at the beginning of the first session (baseline evaluation) and after 128 the last session (post-treatment evaluation). The researcher conducting the evaluations was 129 blinded to the group assignment/allocation. 130 Interventions 131 The interventions were carried out at the Puente Real II nursing home in the city of Badajoz, 132 in the Autonomous Community of Extremadura, Spain (see supplementary material). Both 133 7 control and experimental groups received physical therapy treatment based on a combination 134 of adapted exercises and other physical therapy techniques. The experimental group also 135 received a proprioceptive training program during the same 12-week intervention period. The 136 interventions were supervised by two physical therapists, with more than ten years of 137 experience with older adults. An adherence rate to the interventions of 75% was established as 138 a minimum for participants to be included in the final analysis.18 139 Physical therapy intervention program (Control group) 140 This program was based on a multicomponent physical therapy intervention with a 141 combination of exercises adapted to older adults (in-group) and other physical therapy 142 techniques (individually). In previous studies, multicomponent physical therapy protocols 143 have been used as control groups (a 'standard' package) to evaluate the impacts of different 144 novel physical therapy interventions in various older adult populations.19,20 On the other hand, 145 the standard physical therapy services provided in nursing homes, aged care facilities and 146 other related services in Spain are based on providing these multifaceted interventions21, 147 which are similar to the physical therapy protocol used in the previous studies. 19,20 148 The physical exercise was divided into different sections that were performed in the 149 following order: warm-up, general mobility exercises in sitting and standing positions, games, 150 stretching and return to rest. Exercise sessions were performed once a week (Mondays) for a 151 duration of 45 minutes per session.22,23 Individually, participants from the control group 152 received infrared thermotherapy, neuromuscular electrical stimulation and manual therapy 153 across a range of motion exercises on the spine and upper and lower limbs twice a week 154 (Wednesdays and Fridays) for a duration of 50 minutes per session.22,23 Hence, the control 155 group had 45 minutes (group intervention) plus 100 minutes (individual intervention) a week, 156 with a total of 36 sessions (29 hours) (see supplementary material). 157 8 Physical therapy intervention program + Proprioceptive exercise program (Experimental 158 group) 159 Both the experimental group and the control group received the physical therapy intervention 160 program. Although it was conducted on Mondays, Wednesday and Friday (at the same time) 161 for both groups, the therapy was administered in different rooms for each group to avoid any 162 possible risk of contamination between them in the institutional setting. In addition to the 163 physical therapy intervention program of the control group, the experimental group 164 participated in a proprioceptive training rehabilitation program during the same 12-week 165 period, two days per week (Tuesdays and Thursdays), for a total of 24 sessions (22 hours). 166 Each exercise session had a duration of 55 minutes with three phases: 15 minutes of warm-up 167 with slow walking, mobility and stretching exercises, followed by a 30-minute proprioceptive 168 exercise program, and 10 minutes to cool down using muscle stretches and relaxation 169 exercises (see supplementary material and fig 2). 21 Since only the experimental group 170 participated in a proprioceptive training rehabilitation program during the same 12-week 171 period, the participants from both groups were encouraged not to discuss the intervention 172 outside their cohort. 173 Outcome Measures 174 All instruments were applied in a single day for each participant and the times for baseline 175 and post-treatment testing were consistent for each individual participant. The rater was 176 blinded to group allocation and was the same researcher who collected the baseline clinical 177 data. Demographic, anthropometric, and clinical data were collected using a self-assessment 178 questionnaire developed for this study. The primary outcome was functional mobility 179 measured by the Timed Up and Go (TUG) test,25,26 exhibiting a standard error of measurement 180 (SEM) of 1.27 s for the current sample study, and a minimum detectable change at the 95% 181 9 confidence level (MDC95) of 3.12 s. The secondary outcome measures were: Cooper test27, 182 showing a SEM of 2.14 m, and a MDC95 of 4.01 m; Tinetti scale28,29, with a SEM of 0.41 183 points, and a MDC95 of 1.79 points; One-Leg Stance (OLS) test29,30, reported a SEM of 2.03 184 points, and a MDC95 of 3.96 s; and MORSE scale31, showing a SEM of 1.11 s, and a MDC95 185 of 2.92 points. For a more extended instruments description, please see the supplementary 186 material. 187 Statistical Analysis 188 Data analysis was performed using SPSS version 20.0 (SPSS Inc., Chicago, IL, USA). A 189 descriptive analysis of each of the variables was performed. The normality of the variables 190 was evaluated using the Shapiro-Wilk test, which showed a normal distribution for all the 191 variables and, thus, parametric tests were appropriate. Data are reported as mean ± SD. The 192 demographic and clinical variables of the groups at baseline were compared using the chi- 193 square test for categorical data and the independent-samples t test for quantitative data. A two- 194 way repeated measure ANOVA was performed to analyze the interaction effects of time (at 195 baseline and 3 months post-treatment) in the two intervention groups (experimental and 196 control group). The independent and paired-samples t tests were used for comparisons 197 between and within-groups, respectively. The effect size for between-group and within-group 198 mean differences was calculated using Cohen's d coefficient. A significance level of P<.05 199 was used. 200 Sample Size Estimation 201 G*power 3.1 software was used to calculate the sample size required to detect changes in the 202 primary outcome (Timed Up and Go Test). Assuming an effect size (f) of 0.4 for between- 203 group differences, an alpha level of .05 and power of 80%, a total sample size of 40 204 16 8. Benavent-Caballer V, Sendín-Magdalena A, Lisón JF, et al. Physical factors 347 underlying the Timed "Up and Go" test in older adults. Geriatr Nurs. 2016. 37(2):122- 348 127. 349 9. Pagotto V, Nakatani AY, Silveira EA. Factors associated with poor self-rated health in 350 elderly users of the Brazilian Unified National Health System. Cad Saude Publica. 351 2011. 27(8):1593-1602 352 10. Pérez-Mármol JM, García-Ríos MC, Ortega-Valdivieso MA, et al. Effectiveness of a 353 fine motor skills rehabilitation program on upper limb disability, manual dexterity, 354 pinch strength, range of fingers motion, performance in activities of daily living, 355 functional independency, and general self-efficacy in hand osteoarthritis: A 356 randomized clinical trial. J Hand Ther. 2017. 30(3):262-273.. 357 11. Rogers MW, Tamulevicius N, Coetsee MF, Curry BF, Semple SJ. Knee osteoarthritis 358 and the efficacy of kinesthesia, balance & agility exercise training: a pilot study. Int J 359 Exerc Sci. 2011. 4(2):124-132. 360 12. Cameron ID, Gillespie LD, Robertson MC, et al. Interventions for preventing falls in 361 older people in care facilities and hospitals. Cochrane Database Syst Rev. 2012. 362 12:CD005465. 363 13. Cadore EL, Rodríguez-Mañas L, Sinclair A, Izquierdo M. Effects of different exercise 364 interventions on risk of falls, gait ability, and balance in physically frail older adults: a 365 systematic review. Rejuvenation Res. 2013. 16(2):105-114. 366 14. Guerraz M, Provost S, Narison R, Brugnon A, Virolle S, Bresciani JP. Integration of 367 visual and proprioceptive afferents in kinesthesia. Neuroscience. 2012. 25;223:258- 368 268. 369 17 15. El-Wishy A, Elsayed E. Effect of proprioceptive training program on balance in 370 patients with diabetic neuropathy: a controlled randomized study. Bull Fac Phys Ther. 371 2012. 17(2):1-8. 372 16. Vagetti GC, Barbosa Filho VC, Moreira NB, Oliveira VD, Mazzardo O, Campos WD. 373 Association between physical activity and quality of life in the elderly: a systematic 374 review, 2000-2012. Braz J Psychiatry. 2014. 36(1):76-88. 375 17. Lobo A, Saz P, Marcos G, et al. Revalidación y normalización del Min-Examen 376 Cognoscitivo (primera versión en castellano del Mini-Mental Status Examination) en 377 la población general geriátrica. [Revalidation and standardization of the cognition 378 mini-exam (first Spanish version of the Mini-Mental Status Examination) in the 379 general geriatric population]. Med Clin. 1999. 112(20):767-774. 380 18. Picorelli AM, Pereira LS, Pereira DS, Felício D, Sherrington C. Adherence to exercise 381 programs for older people is influenced by program characteristics and personal 382 factors: a systematic review. J Physiother. 2014. 60(3):151-156. 383 19. Langeard A, Bigot L, Chastan N, Gauthier A. Does neuromuscular electrical 384 stimulation training of the lower limb have functional effects on the elderly?: A 385 systematic review. Exp Gerontol. 2017. 91:88-98. 386 20. Magaziner J, Mangione KK, Orwig D, et al. Effect of a Multicomponent Home-Based 387 Physical Therapy Intervention on ambulation after Hip Fracture in older adults. JAMA. 388 2019. 322(10):946-956. 389 21. Ministerio de Trabajo, Migraciones y Seguridad Social. VII Convenio colectivo marco 390 estatal de servicios de atención a las personas dependientes y desarrollo de la 391 promoción de la autonomía personal - residencias privadas de personas mayores y del 392 servicio de ayuda a domicilio. [VII Collective State Framework Agreement on care 393 services for dependent people and development of the promotion of personal 394 18 autonomy - private nursing homes and home care service for older adults]. Boletín 395 Oficial del Estado «BOE». 2018. 229: 91393-91457. 396 22. Piedras-Jorge C, Meléndez-Moral JC, Tomás-Miguel JM. Beneficios del ejercicio 397 físico en población mayor institucionalizada. [Benefits of physical activity in nursing 398 home residents]. Rev Esp Geriatr Gerontol. 2010. 45(3):131-135. 399 23. Chávez-Pantoja M, López-Mendoza M, Mayta-Tristán P. Efecto de un programa de 400 ejercicios fisioterapéuticos sobre el desempeño físico en adultos mayores 401 institucionalizados. [Effect of a physiotherapy exercise program on physical 402 performance in institutionalized elderly]. Rev Esp Geriatr Gerontol. 2014. 49(6):260- 403 265. 404 24. Albornos-Muñoz L, Moreno-Casbas MT, Sánchez-Pablo C, et al. Efficacy of the 405 Otago exercise programme to reduce falls in community-dwelling adults aged 65-80 406 years old when delivered as group or individual training. J Adv Nurs. 2018. 407 74(7):1700-1711. 408 25. Kristensen MT, Bloch ML, Jønsson LR, Jakobsen TL. Interrater reliability of the 409 standardized Timed Up and Go Test when used in hospitalized and community‐ 410 dwelling older individuals. Physiother Res Int. 2019. 24(2):e1769. 411 26. Hwang R, Morris NR, Mandrusiak A, Mudge A, Suna J, Adsett J, Russell T. Timed up 412 and go test: a reliable and valid test in patients with chronic heart failure. J Card Fail. 413 2016. 22(8):646-650. 414 27. Herbert J, Matłosz P, Czarny W, Śliż M. An objective assessment of men’s physical 415 activity during cooper test based on the direct monitoring by accelerometer 416 actigraphwgt3x. Cent Eur J Sport Sci Med. 2015. 12(4):99–108. 417 19 28. Panella L, Tinelli C, Buizza A, Lombardi R, Gandolfi R. Towards objective 418 evaluation of balance in the elderly: Validity and reliability of a measurement 419 instrument applied to the Tinetti test. Int J Rehabil Res. 2008. 31:65–72. 420 29. Mkacher W, Tabka Z, Trabelsi Y. Minimal detectable change for balance 421 measurements in patients with COPD. J Cardiopulm Rehabil Prev. 2017. 37(3):223- 422 238. 423 30. Goldberg A, Casby A, Wasielewski M. Minimum detectable change for single-leg- 424 stance-time in older adults. Gait & posture. 2011. 33(4):737-739. 425 31. O´Connell B, Myers H. The sensitivity and specificity of the Morse Fall Scale in an 426 acute care setting. J Clin Nurs. 2002. 11(1):134-136. 427 32. Rodríguez MJ, Cano-Deltell EE, Ortega-Valdivieso A, Tapia-Haro RT, García-Ríos 428 MC, Pérez-Mármol JM. Influencia del género y tipo de centro en la volición de 429 personas mayores institucionalizadas. [Influence of gender and type of center on 430 volition of institutionalized older adults]. TOG. 2015. 12(22):1-23. 431 33. Martínez-Amat A, Hita-Contreras F, Lomas-Vega R, Caballero-Martínez I, Alvarez 432 PJ, Martínez-López E. Effects of 12-week proprioception training program on postural 433 stability, gait, and balance in older adults: a controlled clinical trial. J Strength Cond 434 Re. 2013. 27(8):2180-2188. 435 34. Horak FB. Postural orientation and equilibrium: what do we need to know about 436 neural control of balance to prevent falls? Age Ageing. 2006. 35(S2):7-11. 437 35. Huxham FE, Goldie PA, Patla AE. Theoretical considerations in balance assessment. 438 Aust J Physiother. 2001. 47(2):89-100. 439 36. Maribo T, Iversen E, Andersen NT, Stengaard-Pedersen K, Schiøttz-Christensen B. 440 Intra-observer and interobserver reliability of One Leg Stand test as a measure of 441 20 postural balance in low back pain patients. Int Musculoskelet Med. 2009. 31(4):172– 442 177. 443 37. Benavent-Caballer V, Rosado-Calatayud P, Segura-Ortí E, Amer-Cuenca JJ, Lisón JF. 444 The effectiveness of a video-supported group-based Otago exercise programme on 445 physical performance in community-dwelling older adults: a preliminary study. 446 Physiotherapy. 2016. 102(3):280–286. 447 38. Sierra-Silvestre E. Efectividad de la reeducación propioceptiva frente a los ejercicios 448 de fortalecimiento y estiramiento en el equilibrio, marcha, calidad de vida y caídas en 449 ancianos. [Effectiveness of proprioceptive re-education against strength and stretch on 450 balance, gait, quality of life and falls in the elderly]. Cuest fisioter. 2011. 40(1):20-32. 451 39. Giordano A, Bonometti GP, Vanoglio F, et al. Feasibility and cost-effectiveness of a 452 multidisciplinary home telehealth intervention programme to reduce falls among 453 elderly discharged from hospital: study protocol for a randomized controlled trial. 454 BMC Geriatr. 2016. 16(1):209. 455 456 21 Figure legends 457 Fig 1 Flow diagram of patient recruitment following CONSORT guidelines. 458 Fig 2 Images of the proprioceptive therapeutic exercises illustrating the proprioceptive 459 program protocol (main phase - proprioceptive exercise session). 460 461 462 463 464