A home-based exercise program focused on proprioception to reduce falls in frail and pre-frail community-dwelling older adults

Feature Article A home-based exercise program focused on proprioception to reduce falls in frail and pre-frail community-dwelling older adults Pilar P erez-Ros, RN, PhD a,b, * ,1 , Rafael Vila-Candel, RNM, PhD a,c,d,1 , Francisco Miguel Martínez-Arnau, PT, PhD a,b,e a Department of Nursing, Universidad Cat olica de Valencia San Vicente M artir, 46007 Valencia, Spain b Frailty and Cognitive Impairment Research Group (FROG), University of Valencia, 46010 Valencia, Spain c Department of Obstetrics and Gynaecology, Hospital Universitario de la Ribera, FISABIO. Crtra. Corbera km 1, 46600 Valencia, Spain d Department of Nursing, Faculty of Nursing and Podiatry, Universitat de Val encia, Jaume Roig, s/n, 46010 Valencia, Spain e Department of Physiotherapy, Universitat de Val encia, 46010 Valencia, Spain ARTICLE INFO Article history: Received 10 October 2019 Received in revised form 14 January 2020 Accepted 20 January 2020 Available online 18 March 2020 ABSTRACT Frailty and falls are closely associated with each other as well as with disability, hospitalization, and death. Exercise can reduce these risks in both robust and frail older people. This before-after, non-randomized intervention study assessed a one-year proprioception training program with individual daily home exercises in 564 communitydwelling people aged 70 years and over, with different frailty phenotypes. After the exercise program, we observed a moderate reduction in the mean number of falls, fear of falls, body mass index and body fat percentage in frail and pre-frail participants. These results suggest that a home proprioception program may be a viable alternative to complex multicomponent exercise programs in settings where these are not feasible, since home proprioception can reach a larger population at a lower cost, and it affords clear benefits. © 2020 Elsevier Inc. All rights reserved. Keywords: Frail Falls Older people Community dwelling Proprioception exercises INTRODUCTION Falls constitute an important public health problem in adults aged over 65 years due to their medical, psychological and economic consequences. 1 More than 30% of all older adults fall at least once a year, and this is the second leading cause of death due to accidental or unintentional injury worldwide. 2 Frailty and pre-frailty are closely associated with falls, fractures and other osteoarticular problems 3 as well as disability, hospitalization and death. 4 Although the precise characteristics of this clinical syndrome have been described in different ways (mainly relating to weakness, altered balance, and gait problems—all of which can predispose older people to falls), 5 Fried’s 6 definition is the most commonly cited. This author considers frailty to be characterized by at least three of the following five factors: weakness (reduced grip strength), slowness (gait speed), weight loss, low physical activity, and exhaustion. People with one or two of these characteristics are classified as pre-frail, while robust people have none. The prevalence of frailty among community-dwelling individuals aged 65 years or over ranges from 4% to 59.1%. 7 The American College of Sports Medicine holds that participation in regular physical activity elicits a number of favorable responses that contribute to healthy aging. 8 Exercise is recommended in both robust and frail older people, as well as in those with chronic diseases and disabilities. 9,10 Demonstrated benefits include increased mobility and bone mineral density, improved performance of activities of daily living and walking, fewer falls, and a greater overall sense of wellbeing. 1113 Evidence shows that multicomponent programs can reduce frailty by increasing strength and balance. 14 In pre-frail older people, the use of new technologies such as Kinect have also yielded positive results. 15 However, there is no clear consensus as to which strategy is the most suitable for each type of frailty phenotype. 16 In relation to fall prevention, there is likewise a lack of agreement about the most appropriate type of exercise for older people, as factors such as comorbidity; function; and the community, hospital or socialhealth environment can all modify the effects. 17 In community-dwelling older people, interventions have included nutritional programs, strength and balance exercises, tai chi, proprioception, and multicomponent physical activity regimens. 18 In frail populations, fall prevention strategies aim to improve strength, increase muscle mass, 19,20 and promote participation in multicomponent programs, since these also improve socialization and cognition. 21 However, implementing large-scale programs that combine different types of exercise remains challenging. Training is complicated, *Corresponding author: Pilar P erez-Ros, Espartero 7, 46010 Valencia (Spain). E-mail address: [email protected] (P. P erez-Ros). 1 These authors contributed equally to the present study. https://doi.org/10.1016/j.gerinurse.2020.01.017 0197-4572/$ see front matter © 2020 Elsevier Inc. All rights reserved. Geriatric Nursing 41 (2020) 436444 Contents lists available at ScienceDirect Geriatric Nursing journal homepage: www.gnjournal.com as the professionals managing complex exercise programs must invest substantial time in instructing participants, ensuring their comprehension, and monitoring and correcting their performance. Some studies point to a shortage in trained nurses, physiotherapists, and professional instructors who can work full-time on face-to-face physical activity programs. Home-based exercise programs may help to ameliorate this gap in capacity, optimizing the use of resources for professional training and following up older people while averting the need for professionals to directly monitor daily performance. 22,23 Proprioception—the awareness of body posture with respect to the surrounding environment—represents one intervention area that could reduce the risk offalls in older people. Exercises for improving proprioception seek to improve the body's ability to detect movement and the position of its joints, both at rest and in motion. Proprioception influences balance and the perception of one’s posture, and it is also related to the coordination and responsiveness of the nervous system. 24 In this respect, its target differs from strength and multicomponent exercise interventions, which have not been found to improve postural control. 25 If properly carried out, proprioception exercises could be beneficial for improving outcomes in older community members with regard to frailty, function, and the incidence of falls. This study aimed to assess the effects of a one-year home-based proprioception exercise program on the incidence of falls in robust, pre-frail and frail community-dwelling older people. METHODS Study design and participants This before-after non-randomized intervention study included participants in three groups according to their frailty phenotype: robust, pre-frail, and frail. Inclusion criteria were: aged 70 years or older; independent for walking (with possible technical aids, but not assisted by another person); and living within the catchment area of La Ribera Health Department (Valencia, Spain). Exclusion criteria were refusal to participate in the study, the existence of associated diseases resulting in a life expectancy of under 6 months, blindness and deafness, serious psychiatric problems (severe depression subjected to treatment, or acute psychosis), and moderate to severe cognitive impairment (diagnosed previously by a physician or a score of less than 25 on the Mini-Mental State Examination (MMSE 26 with Cronbach’s alpha 0.90 27 ). Participants were recruited from December 2014 to May 2015, and the intervention was carried out in primary care and in social centers for older adults (the latter are regulated by the town hall and offer recreational and cultural activities for users). To encourage participation, posters were hung and flyers distributed; open information sessions were also held for older individuals interested in participating in the study. La Ribera Health Department uses electronic medical records, with patient data from primary, secondary and tertiary care levels. We used these histories to collect data on age, gender, comorbidities (arterial hypertension, diabetes mellitus, and hyperlipidemia), and the number of falls in the 12 months prior to study inclusion, as reported orally by patients or recorded by health professionals following visits to the emergency department after a fall. A single fall over the 12-month period was considered an isolated fall, while two or more falls were defined as recurrent falls. Primary care nurses performed a comprehensive geriatric assessment to categorize patients according to the Fried Frailty Phenotypes 6 (3/5 characteristics = frail; 12 characteristics = pre-frail; 0 characteristics = robust). Weakness was assessed following standardized procedures, using a 100 kg dynamometer (Smedley S, TTM, Tokyo, Japan). Grip strength cutoffs denoting weakness were stratified for gender and body mass index (BMI) and were, for men: BMI 24 kg/m 2 :GS29 kg; BMI 24.128 kg/m 2 :GS30 kg; BMI >28 kg/m 2 :GS32 kg; and for women: BMI 23 kg/m 2 : GS 17 kg; BMI 23.129 kg/m 2 :GS18 kg; BMI >29 kg/m 2 : GS 21 kg. Slowness was dichotomized based on the time taken to walk 4.5 m, with a cutoff value of <0.8 m/s. Unintentional weight loss was defined as a loss of 4.5 kg or 5% of body weight in the last year (determined by direct measurement of weight). Participants were considered to have low physical activity according to the weighted score of kilocalories expended per week (men, 383 kcal/week and women, 270 kcal/week). Lastly, poor endurance and energy were defined by self-reported exhaustion: (a) “I felt that everything I did was an effort”; (b) “I could not get going”. Functional and anthropometric variables were also recorded. Functional parameters were assessed based on the Barthel index with Cronbach's alpha 0.70, 28 the Lawton index with Cronbach's alpha 0.94, 29 and the Tinetti index with Cronbach's alpha 0.95. 30 Anthropometric data comprised BMI; hand grip strength, determined using a KernMap-40 kg dynamometer; body fat percentage, determined by bioelectrical impedance analysis (Tanita BC-601); and the Mini-Nutritional Assessment Short Form (MNA-SF) with Cronbach's alpha 0.670. 31 In addition, we collected data on fear of falls (modified Falls Efficacy Scale International, FES-I, a=0.96) 32 and the weekly hours of exercise in the previous 12 months according to participant self-report. The Clinical Research Ethics Committee of Hospital Universitario de la Ribera (Valencia, Spain) approved the study, and each participant signed informed consent before inclusion in the study and statistical processing of the data. Intervention The intervention consisted of a one-year daily proprioceptive home exercise program and was carried out by eight community nurses in primary care centers, who had four years’experience in physical activityrelated fall prevention programs. Participants were advised to perform the exercises, in the morning whenever possible, on 5 days a week. Each exercise session lasted approximately 40 min to 50 min and consisted of a 10-min warm-up period with slow walking, stretching and mobility exercises; 20 min to 30 min of proprioceptive exercises; and a 10-min cool-down with stretching and relaxation exercises. Exercises included dynamic and static positions, and their intensity and phases were tailored to participants’abilities. Exercises 1 to 5 were performed in two series of 10 to 15 repetitions, while exercises 6 to 12 were performed in two series of 15 s to 30 s; participants rested for one minute between exercises (Supplementary file 1). 33,34 Outcomes were measured at 12 months’follow-up. Treatment fidelity The indications of the NIH Behavior Change Consortium were followed to enhance treatment fidelity, 35 that is, to ensure participants received the same treatment dose within study conditions and an equivalent dose across conditions. Three senior researchers (two nurses and one physiotherapist) worked with the eight primary care nurses to monitor implementation and apply corrective measures when necessary. During the initial 60 min to 80 min visit with the patient, the nurses met with participants to provide information on the benefits of an environment free of fall risks and to explain the proprioception exercises that the patients should perform at home. Participants were also given a document specifying the exercises to be performed (Supplementary file 1), the number of repetitions, and the length of time, as well as an exercise record sheet to record their activities and duration (Supplementary file 2). The nurses who were personally supervising the patients phoned them each month to follow up. They recorded the number of falls, defined as an event in which a person inadvertently comes to rest on P. P erez-Ros et al. / Geriatric Nursing 41 (2020) 436444 437 the ground, floor, or some other lower level, 2 occurring over the last 30 days. The nurses specifically asked the following: “Have you fallen in the last month, inadvertently coming to rest on the ground or floor or some other lower level?”The nurses subsequently asked about how participants were getting on with the exercises and whether they had any doubts, and they reminded the patients to document the activities performed on the exercise record sheet. If participants had doubts that could not be resolved by telephone, an appointment was arranged for improving and correcting performance. In addition to these monthly check-ins, every three months the nurses visited all participants to make any necessary modifications to the exercise regimen, according to participants’progress or changes in their functional or comorbidity status. The quarterly visits lasted 40 min to 60 min, and the follow-up visits to resolve participants’doubts, 20 min to 30 min. Strategies for monitoring and improving provider training included a standardized training protocol and exercise program sheet. Four nurses from the research team were assigned to each primary care center, while the quarterly visits were conducted by two different, randomly selected nurses to minimize provider differences. In order to ensure provider skill acquisition, the nurses evaluated the entire exercise session to correct any potential errors in technique by the participants. The research team met monthly to minimize “drift” in provider skills and resolve doubts on how to adapt the exercises according to participants’specific pathologies or capacities. Different aspects were monitored to safeguard the fidelity of the interventions. Participants could submit complaints or suggestions, which helped to detect differences in the delivery of treatment, and adherence to treatment protocols were evaluated according to the exercise sheet and training record. Participants’comprehension of the exercise regimen was ensured, initially through the study exclusion criteria (i.e. individuals with cognitive impairment were ineligible) and then through follow-up visits to monitor performance technique by means of a checklist and analysis of difficulties encountered in adherence (time spent on the exercise, number of visits needed to resolve doubts). Statistical analysis The sample size was calculated based on the 2013 population census. The region of La Ribera (Valencia, Spain) has a population of about 253,330 inhabitants (15.8% over 70 years of age). Based on an assumed incidence of falls of 35% and an estimated reduction of 8% (with alpha error of 5% and statistical power of 95%), a sample of 437 participants was required. This figure was increased to 525 to control for an estimated proportion of dropouts of 20%. The variables are reported as proportions and/or means and standard deviations (SD). The Kolmogorov-Smirnov test was used to assess normality, and the Levene test was applied to explore homogeneity of variances for continuous variables (age, Barthel Index,LawtonIndex,TinettiIndex,MNA-SFscale,BMI,bodyfat percentage, handgrip and number of falls). There were no significant outliers. The data met the main assumptions of the t-test for independent samples, so parametric testing (analysis of variance [ANOVA]) was used to compare quantitative variables (age), while nonparametric tests (chi-squared test) were used to compare categorical variables (gender, comorbidity, percentage of fallers, recurrent fallers, and physical activity). Outcomes were assessed by analyzing the number of falls, FES-I scale, Barthel Index, Lawton Index,TinettiIndex,MNA-SFscale,BMI,bodyfatpercentage,and handgrip data, based on two-tailed mixed-effect (between-within) ANOVA including three groups (frail, pre-frail, and robust) at baseline and post-intervention, with repeated measurement of the last factor using 95% confidence intervals (95% CI). The data met the main assumptions of ANOVA: independence of cases, normality, and equality. Effect sizes (eta-squared) for ANOVA were also calculated, with values of more than 0.01 considered small; more than 0.058, moderate; and more than 0.138, large. Study data were entered into MS Excel spreadsheets, where each qualitative variable with assigned values (e.g. man/woman) or quantitative variable with a range of values (e.g. Barthel from 0 to 100) was processed with drop-down lists to avoid entering erroneous data. Statistical analysis was undertaken using the SPSS version 23.0 statistical package (IBM SPSS Statistics). RESULTS Of the 732 people initially evaluated to participate, 168 were excluded (22.9%), with reasons: 6 (3.5%) did not meet the selection criteria, 126 (75.0%) declined to participate, and 36 (21.5%) failed to answer the telephone when called to attend the information session. The final study sample thus comprised 564 participants. According to the Fried Frailty Phenotype criteria, 10.99% of the participants (n= 62) were categorized as frail, 72.87% (n= 411) as pre-frail, and 16.13% (n= 91) as robust (Fig. 1). Table 1 shows participants’baseline characteristics by frailty phenotype. Frailty was positively correlated with age: robust participants were younger than pre-frail and frail individuals. There were more women in both the pre-frail group (67.1%, n= 276) and the frail group (79.01%; n= 49). No differences were observed in cognitive function (Table 1). Just 9.6% (n= 55) of the participants were able to complete the program without any follow-up visits to resolve their doubts. Over the one-year intervention, frail participants requested a mean 4.3 revisits for this purpose, compared to 5.35 re-visits in pre-frail participants and 5.15 re-visits in robust participants; these differences were not significant. Most of these re-visits (78.99%, n= 2264) were in the first semester of follow-up. Frail and pre-frail older adults were significantly more adherent to the exercise regimen than robust participants (p<0.001; Table 2), with significant increases in weekly hours of physical activity in the frail and pre-frail groups (Table 3). The prevalence of falls in the 12 months prior to the start of the study was 70.03% (n= 395), with a higher percentage of fallers in the frail group (p<0.01). There were no differences in recurrent fallers between groups. During the intervention year, the overall incidence of falls decreased to 38.74% (n= 210) due to reductions in the frail and pre-frail groups (Table 3 and Fig. 2). Likewise, in the pre-study year frail older participants showed a higher number of mean falls (1.46) compared to the pre-frail (0.66 falls) and robust groups (0.23 falls), and they had a higher fear of falling (FES-I score 28.16 versus 18.85 versus 10.95, respectively). By study end, mean falls had moderately decreased in both the frail and pre-frail groups (h 2 = 0.058), and the differences between groups had disappeared. Similarly, the differences in FES-I score disappeared, with a lower fear of falls in the frail and pre-frail groups (Table 4 and Fig. 2; mean differences between groups are reported in Supplementary file 3). Functional assessment revealed high functionality, with no differences between groups (p= 0.07), though the frail participants scored slightly lower on the Barthel Index, Lawton Index, and Tinetti Index (Table 4 and Fig. 2). Statistically significant variations were observed in BMI, with the pre-frail participants obtaining the greatest benefitfollowing the study intervention (mean difference 0.23 kg/m 2 ;p<0.01; Supplementary file 3). Although there were no differences between groups in the body fat percentage after the intervention, intra-group (pre-post) differences were observed in the pre-frail group (mean difference 1.05%; p<0.01), while non-significantreductionswereseeninthefrail (mean difference 0.36%) and robust individuals (mean difference 0.33%). At the end of the study, all groups showed a stronger handgrip, with the largest improvements in the frail individuals (Table 4;Fig. 2). The frailty phenotype was re-assessed at the end of the study, revealing a decrease in the proportion of frail (5.8% of the total sample; n= 32) and pre-frail individuals (71.5%, n= 391), and an increase in robust individuals (22.81%; n= 125). 438 P. P erez-Ros et al. / Geriatric Nursing 41 (2020) 436444 Evaluated for selecon (n=732) Final sample (n=564) Frail (n=62) Month 1: follow-up visits for doubts n=52 Month 2: follow-up visits for doubts n=44 Month 3: follow-up visits for doubts n=40 Lost to follow-up at 3 months (n=2) Month 4: follow-up visits for doubts n=38 Month 5: follow-up visits for doubts n=31 Month 6: follow-up visits for doubts n=22 Lost to follow-up at 6 months (n=2) Month 7: follow-up visits for doubts n=17 Month 8: follow-up visits for doubts n=13 Month 9: follow-up visits for doubts n=7 Lost to follow-up at 9 months (n=2) Month 10: follow-up visits for doubts n=2 Month 11: follow-up visits for doubts n=1 Month 12: follow-up visits for doubts n=0 Lost to follow-up at 12 months (n=2) Analysed (n=60) - Excluded from anaysis (n=2) Pre-frail (n=411) Month 1: follow-up visits for doubts n=368 Month 2: follow-up visits for doubts n=329 Month 3: follow-up visits for doubts n=292 Lost to follow-up at 3 months (n=6) Month 4: follow-up visits for doubts n=261 Month 5: follow-up visits for doubts n=222 Month 6: follow-up visits for doubts n=195 Lost to follow-up at 6 months (n=9) Month 7: follow-up visits for doubts n=159 Month 8: follow-up visits for doubts n=123 Month 9: follow-up visits for doubts n=89 Lost to follow-up at 9 months (n=11) Month 10: follow-up visits for doubts n=61 Month 11: follow-up visits for doubts n=27 Month 12: follow-up visits for doubts n=4 Lost to follow-up at 12 months (n=12) Analysed (n=399) - Excluded from anaysis (n=12) Robust (n=91) Month 1: follow-up visits for doubts n=80 Month 2: follow-up visits for doubts n=74 Month 3: follow-up visits for doubts n=67 Lost to follow-up at 3 months (n=0) Month 4: follow-up visits for doubts n=59 Month 5: follow-up visits for doubts n=51 Month 6: follow-up visits for doubts n=39 Lost to follow-up at 6 months (n=1) Month 7: follow-up visits for doubts n=33 Month 8: follow-up visits for doubts n=26 Month 9: follow-up visits for doubts n=17 Lost to follow-up at 9 months (n=1) Month 10: follow-up visits for doubts n=13 Month 11: follow-up visits for doubts n=5 Month 12: follow-up visits for doubts n=5 Lost to follow-up at 12 months (n=1) Analysed (n=90) - Excluded from anaysis (n=1) Excluded (n=168) - Do not meet selecon criteria (n=6) - Declines to parcipate (n=126) - Did not answer telephone (n=36) Sample at study end (n=549) Fig. 1. Study flowchart. P. P erez-Ros et al. / Geriatric Nursing 41 (2020) 436444 439 DISCUSSION In this one-year home-based proprioception exercise program, frail and pre-frail older adults living in their community achieved a moderate decrease in the incidence of falls and increased the weekly hours dedicated to physical activity. We also observed a lessened fear of falls and improved anthropometric parameters, along with a decrease in the number of older adults categorized as frail and prefrail; indeed, participants with these phenotypes at baseline experienced the greatest benefits. Table 1 Baseline participant characteristics, according to frailty phenotype. Frail (n= 62) Pre-frail (n= 411) Robust (n= 91) Total (n= 564) p-value a n(%) n(%) n(%) n(%) Women 49 (79.01) 276 (67.1) 31 (34.1) 356 (63.1) <0.01 Arterial hypertension 48 (77.42) 262 (63.74) 60 (65.93) 370 (65.6) 0.11 Diabetes mellitus 31 (50) 111 (27) 20 (21.98) 162 (28.72) <0.01 Hyperlipidemia 30 (57.69) 177 (43.06) 36 (39.56) 243 (43.08) 0.56 Mean (SD) Mean (SD) Mean (SD) Mean (SD) p-value b Post hoc Age, years 77.97 (3.97) 76.13 (3.98) 74.37 (3.25) 76.05 (3.97) <0.01 c, ** d, ** e, * Mini Mental State Examination (MMSE) 28.02 (1.74) 27.84 (1.68) 27.45 (1.5) 27.85 (1.68) 0.41 a Chi-squared test. b ANOVA Games Howell post hoc test. c frail vs. pre-frail. d frail vs. robust. e pre-frail vs. robust.P-value. *p<0.05. ** p<0.01. Table 2 Percentage of exercise days and mean number of re-visits for resolving participant doubts about exercises. Frail (n= 60) Pre-frail (n= 399) Robust (n= 90) Total (n= 549) p-value a Percentage of exercise days n(%) n(%) n(%) n(%) 25% 0 (0) 0 (0) 19 (21.1) 19 (3.5) <0.01 26% to 50% 7 (10.7) 101 (25.3) 35 (38.9) 143 (26.0) 51% to 75% 38 (64.3) 187 (46.9) 12 (13.3) 237 (43.2) 76% to 100% 15 (25) 111 (27.8) 24 (26.7) 150 (27.3) Mean (SD) Mean (SD) Mean (SD) Mean (SD) p-value b Re-visits 4.3 (3.17) 5.35 (3.4) 5.15 (3.47) 5.22 (3.51) 0.105 The percentages were calculated on the basis of a total of 250 days (100%) per year. After deducting weekends, public holidays and a holiday month. a Chi-squared test. b ANOVA.P-value: *p<0.05; **p<0.01. Table 3 Before-after distribution of frailty phenotype in fallers and by weekly hours of physical activity. Group n Pre-test (%) p-value a nPost-test (%) p-value a Fallers Frail 34 54.84 <0.01 5 15.62 0.03 Pre-frail 152 36.98 104 26.59 Robust 13 14.29 31 24.8 Recurrent fallers Frail 20 58.82 0.25 3 60 <0.01 Pre-frail 67 44.07 29 27.8 Robust 5 38.46 15 48.38 Physical activity <3 h/w Frail 62 100 <0.01 25 78.12 <0.01 Pre-frail 180 43.79 137 35.03 Robust 2 0.2 5 0.04 Physical activity 36 h/w Frail 0 0.0 7 21.87 Pre-frail 127 30.9 149 38.11 Robust 39 44.85 64 51.2 Physical activity >6 h/w Frail 0 0.0 0 0 Pre-frail 104 25.3 105 26.86 Robust 50 54.95 26 44.8 Fallers: 1 fall over follow-up. Recurrent faller: 2 falls over follow-up. a Chi-square test. 440 P. P erez-Ros et al. / Geriatric Nursing 41 (2020) 436444 The published literature is unclear as to which type of exercise is most appropriate for these populations, 16,36 with different studies assessing proprioception, tai chi, 37 and multicomponent 3841 and resistance exercise. 42 Variables such as patients’functional status and comorbidity, polypharmacy, and individual versus group settings can influence the choice of activity. 8 In older adults who are frail and pre-frail, starting with a proprioception program may be the most appropriate approach, as the low intensity of these exercises is suitable for people with functional limitations, increasing the likelihood of adherence. While group exercise is the most effective modality, group studies are difficult to perform due to a lack of space in which to carry out the activities and limited economic resources for paying instructors. 22,23 Home exercises like the ones in our study have proven effective in reducing falls, 18 but ensuring patients’adherence is more difficult, as observed in our robust participants, who actually saw a slight increase 0 20 40 60 80 100 120 Pre-test Post-test points Barthel Index Frail * 0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 5 Pre-test Post-test events Falls Frail Prefrail Robust ** ** ** 0 5 10 15 20 25 30 35 Pre-test Post-test points FESI Frail Prefrail Robust 0 2 4 6 8 10 Pre-test Post-test points Lawton Index Frail Prefrail Robust 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 Pre-test Post-test points Tine Index Frail PreFrail Robust 0 2 4 6 8 10 12 14 16 Pre-test Post-test points sMNA Frail Prefrail Robust 0 5 10 15 20 25 30 35 40 45 Pre-test Post-test kg/m2 BMI Frail Prefrail Robust 0 10 20 30 40 50 Pre-test Post-test % Fat Mass Frail Prefrail Robust ** 0 5 10 15 20 25 30 35 40 45 Pre-test kg Handgrip Frail Prefrail Robust ** ** * ** ** ** ** ** * ** ** Post-test ** Fig. 2. Results of the group x time comparative analysis, showing the effects of the intervention. Falls, FES-I (Falls Efficacy Scale International), Barthel Index, Lawton Index, Tinetti Index, MNAÒ-SF (Mini Nutritional Assessment Short Form), BMI (Body Mass Index), Fat Mass, Handgrip. FES-I (Falls Efficacy Scale International) F: frail participants; PF: Pre-frail participants; R: robust participants. FES-I assesses fear of falling based on a scale of 1664; a maximum score indicates maximum fear. The Barthel Index assesses function referred to activities of daily living based on a scale of 0100; a maximum score indicates independency. The Lawton Index assesses function related to instrumental activities of daily living on a scale of 08; a maximum score indicates independency. The Tinetti Index evaluates gait and balance based on a scale of 028; a maximum score indicates no risk. MNAÒ-SF assesses nutritional status based on a scale of 016; a maximum score is indicative of optimal status. Significant at *p<0.05, **p<0.01. P. P erez-Ros et al. / Geriatric Nursing 41 (2020) 436444 441 in the incidence of falls with respect to the previous year. This group’s perceptions of their good health may have led them to underestimate their vulnerability to falls and to disregard the importance of adhering to an exercise program. 43 At the same time, there was no decrease in recurrent fallers, results that are consistent with the scarce evidence on the effectiveness of home-based programs for reducing the number of recurrent falls in frail older people. 44 Further research is thus required in this specific population. At baseline, the fear of falls was greater in fallers and recurrent fallers; however, by study end, these between-group differences had disappeared, corroborating the results from other studies showing the effectiveness of the intervention. 22,45 The study sample was functionally independent in the performance of basic and instrumental activities of daily living, including mobility, with no differences according to frailty status. In contrast, several studies 4,5 have reported that frailty is related to disability; this difference is probably attributable to our inclusion criteria (independent walkers living in the community). We also observed that frailty is associated with advanced age, obesity, increased anthropometric parameters, and lesser handgrip strength, results that contradict conventionally held beliefs about the association between frailty and thinness. 4648 The increase in physical activity proved beneficial for reducing anthropometric parameters such as BMI and body fat percentage. Such findings complement evidence from the literature showing that regular physical activity is safe for robust and frail older people alike, reducing their risk of major cardiovascular and metabolic diseases, obesity, falls, cognitive impairment, osteoporosis, and muscle weakness. 23 In addition to the decrease in falls and improvement in the clinical parameters, our participants improved their frailty status compared to baseline. Although multicomponent exercise programs are supported by a larger body of evidence regarding the reversal of frailty, 21 our results suggest that home-based programs may also be beneficial. Continuous follow-up over 12 months, with monthly telephone calls and quarterly visits, may encourage adherence by making patients feel supported by health professionals and accountable to following healthier physical activity behaviors. Home-based proprioception programs are a viable alternative where resource limitations preclude group exercises. The exercise instructions are simpler for proprioception than for multicomponent Table 4 Interaction effects of groups and assessment time points in relation to outcomes in frail (N= 60), pre-frail (N= 399), and robust (N= 90) participants. Outcomes by frailty phenotype Pre Mean (SD) Post Mean (SD) Mean difference (95% CI) F a p-value h 2 Falls (n) Frail 1.46 (2.24) 0.53 (1.01) 0.93 (1.32 to 0.54)** 10.86 <0.01 0.058 Pre-frail 0.66 (1.2) 0.36 (0.73) 0.3 (0.045 to 0.15)** Robust 0.23 (0.67) 0.48 (0.93) 0.24 (0.07 to 0.56) FES-I (scale 1664; higher score = more fear of falling) Frail 28.16 (2.07) 20.91 (2.14) 7.25 (14.64 to 0.14)*9.12 <0.01 0.052 Pre-frail 18.85 (0.8) 19.71 (0.83) 0.86 (1.46 to 3.19) Robust 10.95 (1.69) 20.12 (1.74) 9.17 (5.26 to 13.09)** Barthel Index (scale 0100; higher score indicates more independence on ADL) Frail 92.18 (10.47) 92.58 (10.9) 0.50 (0.56 to 1.56) 2.63 0.07 0.01 Pre-frail 93.64 (9.78) 93.7 (9.38) 0.13 (0.62 to 0.37) Robust 94.89 (7.96) 93.61 (8.51) 1.22 (2.19 to 0.25)* Lawton Index (scale 08; higher score indicates more independence on instrumental ADL) Frail 7.15 (0.14) 7.13 (1.11) 0.02 (0.15 to 0.11) 0.13 0.87 0.001 Pre-frail 7.32 (0.06) 7.35 (0.05) 0.03 (0.04 to 0.09) Robust 7.46 (0.95) 7.47 (0.85) 0.01 (0.10 to 0.12) Tinetti Index (scale 028; higher score indicates lower risk related to gait and balance) Frail 25.47 (0.43) 25.45 (0.41) 0.02 (0.54 to 0.51) 0.01 0.99 0.001 Pre-frail 25.85 (0.16) 25.86 (0.16) 0.01 (0.15 to 0.15) Robust 25.93 (0.35) 25.95 (0.33) 0.02 (0.43 to 0.48) MNA-SF (scale 014; higher score indicates better nutritional status) Frail 13.45 (0.07) 13.548 (0.07) 0.03 (0.26 to 0.10) 0.69 0.5 0.003 Pre-frail 13.61 (0.03) 13.62 (0.03) 0.01 (0.05 to 0.07) Robust 13.46 (0.79) 13.49 (0.79) 0.03 (0.11 to 0.18) BMI, kg/m 2 Frail 31.83 (0.58) 31.51 (0.57) 0.12 (0.76 to 0.13) 0.02 0.8 0.001 Pre-frail 30.13 (0.22) 29.9 (0.24) 0.23 ( 0.37 to 0.10)** Robust 29.08 (0.46) 28.9 (0.42) 0.16 (0.48 to 0.16) Body fat, % Frail 41.60 (7.29) 41.24 (7.32) 0.36 (1.04 to 0.32) 1.8 0.17 0.007 Pre-frail 39.2 (6.95) 38.15(7.1) 1.05 (1.46 to 0.64)** Robust 34.64 (6.49) 34.3 (6.09) 0.33 ( 1.04 to 0.38) Handgrip, kg Frail 14.26 (4.93) 16.05 (5.26) 1.79 (1.02 to 2.57)** 1.22 0.29 0.004 Pre-frail 18.93 (7.69) 20.55 (7.7) 1.59 (1.23 to 1.96)** Robust 31.17 (6.85) 32.17 (6.71) 1.00 (0.34 to 1.3)* ADL: activities of daily living; BMI (Body Mass Index). MNA-SF (Mini Nutritional Assessment - Short Form); FES-I (Falls Efficacy Scale International); SD: standard deviation. Significant at. *p<0.05. ** p<0.01.F a : two-way ANOVA (repeated measures). h 2 = eta squared (effect size). Thresholds for h 2 :>0.01, small; >0.059, moderate; >0.138, large. 442 P. P erez-Ros et al. / Geriatric Nursing 41 (2020) 436444 programs, can be applied by nurses and physiotherapists, and can reach a large population. Limitations The nurses conducting the intervention were not exempt from possible interpretational errors or the risk of information bias, despite the simplicity of the items assessed. Furthermore, the number of falls in the previous 12 months may have been under-recorded due to recall bias or reporting bias (e.g. due to shame) on the part of participants. The time, weather conditions and location of the falls were not compiled, and the follow-up period was limited to 12 months. Additionally, measurement bias may have affected the risk factors for falls, and inter-rater reliability was not established among the rating nurses. On the other hand, the sample was rigorously selected, with few dropouts, and the sample size was large and sufficient for the estimations made. A final limitation was that cognitive status was assessed only at baseline, and although older people with moderate to severe cognitive impairment were excluded, some participants may have lost cognitive ability over the course of the study. CONCLUSIONS A 12-month home proprioception exercise program decreased the incidence of falls in frail and pre-frail community-dwelling older adults. The program was more effective in frail and pre-frail groups than in robust participants. Adherence to exercise reduces the incidence of falls and the presence of frailty criteria in community-dwelling older people. Declaration of Competing Interest The authors declare that they have no conflicts of interest in relation to the present study. CRediT authorship contribution statement Pilar P erez-Ros: Conceptualization, Data curation, Formal analysis, Writing - review & editing. Rafael Vila-Candel: Conceptualization, Data curation, Formal analysis, Writing - review & editing. Francisco Miguel Martínez-Arnau: Conceptualization, Data curation, Formal analysis, Writing - review & editing. Acknowledgments The authors wish to thank all the members of the La Ribera Health Department for helping to make this study possible. Funding The translation of the manuscript has been financed by the Universidad Cat olica de Valencia San Vicente M artir. None of the authors received more financial support for this study. No more funding was received for this study. The Government authorities, University of Valencia and Hospital Universitario de la Ribera played no role in the conduction of this study. Supplementary materials Supplementary material associated with this article can be found in the online version at doi:10.1016/j.gerinurse.2020.01.017. REFERENCES 1. Tinetti ME, Speechley M, Ginter SF. Risk factors for falls among elderly persons living in the community. N Engl J Med. 1988;319(26):1701–1707. https://doi.org/ 10.1056/NEJM198812293192604. 2. Caídas. 2018 https://www.who.int/es/news-room/fact-sheets/detail/falls. Accessed 15 July 2019. 3. Kojima G, Iliffe S, Morris RW, et al. Frailty predicts trajectories of quality of life over time among British community-dwelling older people. Qual Life Res. 2016;25:1743–1750. https://doi.org/10.1007/s11136-015-1213-2. 4. Rodríguez-Ma~ nas L, F eart C, Mann G, et al. Searching for an operational definition of frailty: a Delphi method based consensus statement: the frailty operative definitionconsensus conference project. J Gerontol A Biol Sci Med Sci. 2013;68(1):62–67. https://doi.org/10.1093/gerona/gls119. 5. Kojima G. Frailty as a predictor of future falls among community-dwelling older people: a systematic review and Meta-analysis. J Am Med Dir Assoc. 2015;16 (12):1027–1033. https://doi.org/10.1016/j.jamda.2015.06.018. 6. Fried LP, Tangen CM, Walston J, et al. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001;56(3):M146–M156. https://doi.org/ 10.1093/gerona/56.3.m146. 7. Collard RM, Boter H, Schoevers RA, Oude Voshaar RC. Prevalence of frailty in community-dwelling older persons: a systematic review. J Am Geriatr Soc. 2012;60 (8):1487–1492. https://doi.org/10.1111/j.1532-5415.2012.04054.x. 8. de Labra C, Guimaraes-Pinheiro C, Maseda A, Lorenzo T, Mill an-Calenti JC. Effects of physical exercise interventions in frail older adults: a systematic review of randomized controlled trials. BMC Geriatr. 2015;15(154):1–16. https://doi.org/10.1186/s12877015-0155-4. 9. Galloza J, Castillo B, Micheo W. Benefits of exercise in the older population. Phys Med Rehabil Clin N Am. 2017;28(4):659–669. https://doi.org/10.1016/j.pmr.2017.06.001. 10. Marzetti E, Calvani R, Tosato M, et al. Physical activity and exercise as countermeasures to physical frailty and sarcopenia. Aging Clin Exp Res. 2017;29(1):35–42. https://doi.org/10.1007/s40520-016-0705-4. 11. Drey M, Zech A, Freiberger E, et al. Effects of strength training versus power training on physical performance in prefrail community-dwelling older adults. Gerontology. 2012;58(3):197–204. https://doi.org/10.1159/000332207. 12. Gin e-Garriga M, Roqu e-Fíguls M, Coll-Planas L, Sitj a-Rabert M, Salv a A. Physical exercise interventions for improving performance-based measures of physical function in community-dwelling, frail older adults: a systematic review and metaanalysis. Arch Phys Med Rehabil. 2014;95(4):753–769.e3. https://doi.org/10.1016/j. apmr.2013.11.007. 13. P erez-Ros P, Martínez-Arnau FM, Tarazona-Santabalbina FJ. Risk factors and number of falls as determinants of quality of life of community-dwelling older adults. J Geriatr Phys Ther. 2019;42(2):63–72. https://doi.org/10.1519/JPT.0000000000000150. 14. Haider S, Grabovac I, Dorner TE. Effects of physical activity interventions in frail and prefrail community-dwelling people on frailty status, muscle strength, physical performance and muscle mass—a narrative review. Wien Klin Wochenschr. 2019;131(11):244. https://doi.org/10.1007/s00508-019-1484-7. 15. Takano E, Teranishi T, Watanabe T, et al. Differences in the effect of exercise interventions between prefrail older adults and older adults without frailty: a pilot study. Geriatr Gerontol Int. 2017;17(9):1265–1269. https://doi.org/10.1111/ggi.12853. 16. Silva RB, Aldoradin-Cabeza H, Eslick GD, Phu S, Duque G. The effect of physical exercise on frail older persons: a systematic review. J Frailty Aging. 2017;6(2):91– 96. https://doi.org/10.14283/jfa.2017.7. 17. Rimland JM, Abraha I, Dell’Aquila G, et al. Effectiveness of non-pharmacological interventions to prevent falls in older people: a systematic overview. the senator project ontop series. PLoS ONE. 2016;11:(8) e0161579. https://doi.org/10.1371/ journal.pone.0161579. 18. Sherrington C, Fairhall NJ, Wallbank GK, et al. Exercise for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2019;1: CD012424. https://doi.org/10.1002/14651858.CD012424.pub2. 19. Liu L-K, Lee W-J, Chen L-Y, et al. Association between frailty, osteoporosis, falls and hip fractures among community-dwelling people aged 50 years and older in taiwan: results from I-Lan longitudinal aging study. PLoS ONE. 2015;10:(9) e0136968. https://doi.org/10.1371/journal.pone.0136968. 20. Yoo JS, Kim CG, Yim J, Jeon MY. Factors influencing falls in the frail elderly individuals in urban and rural areas. Aging Clin Exp Res. 2016;28(4):687–697. https://doi. org/10.1007/s40520-015-0469-2. 21. Tarazona-Santabalbina FJ, G omez-Cabrera MC, P erez-Ros P, et al. A multicomponent exercise intervention that reverses frailty and improves cognition, emotion, and social networking in the community-dwelling frail elderly: a randomized clinical trial. J Am Med Dir Assoc. 2016;17(5):426–433. https://doi.org/10.1016/j. jamda.2016.01.019. 22. Kapan A, Luger E, Haider S, et al. Fear of falling reduced by a lay led home-based program in frail community-dwelling older adults: a randomised controlled trial. Arch Gerontol Geriatr. 2016;68:25–32. https://doi.org/10.1016/j.archger.2016.08.009. 23. McPhee JS, French DP, Jackson D, Nazroo J, Pendleton N, Degens H. Physical activity in older age: perspectives for healthy ageing and frailty. Biogerontology. 2016;17:567–580. https://doi.org/10.1007/s10522-016-9641-0. 24. Pollock AS, Durward BR, Rowe PJ, Paul JP. What is balance? Clin Rehabil. 2000;14 (4):402–406. https://doi.org/10.1191/0269215500cr342oa. 25. Low DC, Walsh GS, Arkesteijn M. Effectiveness of exercise interventions to improve postural control in older adults: a systematic review and meta-analyses of centre of pressure measurements. Sports Med. 2017;47(1):101–112. https://doi.org/ 10.1007/s40279-016-0559-0. P. P erez-Ros et al. / Geriatric Nursing 41 (2020) 436444 443 26. Folstein MF, Folstein SE, McHugh PR. “Mini-mental state”. a practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975;12 (3):189–198. 27. Foreman MD. Reliability and validity of mental status questionnaires in elderly hospitalized patients. Nurs Res. 1987;36(4):216. 28. Bernaola-Sagardui I. Validation of the Barthel Index in the Spanish population. Enferm Clin. 2018;28(3):210–211. https://doi.org/10.1016/j.enfcli.2017.12.001. 29. Vergara I, Bilbao A, Orive M, Garcia-Gutierrez S, Navarro G, Quintana JM. Validation of the Spanish version of the Lawton IADL Scale for its application in elderly people. Health Qual Life Outcomes. 2012;10:130. https://doi.org/10.1186/1477-7525-10-130. 30. Guevara CR, Lugo LH. Validez y confiabilidad de la Escala de Tinetti para poblaci on colombiana. Rev Colomb Reumatol. 2012;19(4):218–233. https://doi.org/10.1016/ S0121-8123(12)70017-8. 31. Kaiser MJ, Bauer JM, Ramsch C, et al. Validation of the Mini Nutritional Assessment short-form (MNA-SF): a practical tool for identification of nutritional status. J Nutr Health Aging. 2009;13(9):782–788. 32. Yardley L, Beyer N, Hauer K, Kempen G, Piot-Ziegler C, Todd C. Development and initial validation of the Falls Efficacy Scale-International (FES-I). Age Ageing. 2005;34(6):614–619. https://doi.org/10.1093/ageing/afi196. 33. P erez-Ros P, Martinez-Arnau FM, Malafarina V, Tarazona-Santabalbina FJ. A one-year proprioceptive exercise programme reduces the incidence of falls in community-dwelling elderly people: a before-after non-randomised intervention study. Maturitas. 2016;94:155–160. https://doi.org/10.1016/j.maturitas.2016.09.007. 34. Martínez-Amat A, Hita-Contreras F, Lomas-Vega R, Caballero-Martínez I, Alvarez PJ, Martínez-L opez E. Effects of 12-week proprioception training program on postural stability, gait, and balance in older adults: a controlled clinical trial. J Strength Cond Res. 2013;27(8):2180–2188. https://doi.org/10.1519/JSC.0b013e31827da35f. 35. Bellg AJ, Borrelli B, Resnick B, et al. Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH behavior change consortium. Health Psychol. 2004;23(5):443–451. https://doi.org/10.1037/ 0278-6133.23.5.443. 36. Shubert TE. Evidence-based exercise prescription for balance and falls prevention: a current review of the literature. J Geriatr Phys Ther. 2011;34(3):100–108. https:// doi.org/10.1519/JPT.0b013e31822938ac. 37. Taylor D, Hale L, Schluter P, et al. Effectiveness of tai chi as a community-based falls prevention intervention: a randomized controlled trial. J Am Geriatr Soc. 2012;60 (5):841–848. https://doi.org/10.1111/j.1532-5415.2012.03928.x. 38. Clemson L, Fiatarone Singh MA, Bundy A, et al. Integration of balance and strength training into daily life activity to reduce rate of falls in older people (the LiFE study): randomised parallel trial. BMJ. 2012;345:e4547. https://doi.org/10.1136/ bmj.e4547. 39. Lord SR, Castell S, Corcoran J, et al. The effect of group exercise on physical functioning and falls in frail older people living in retirement villages: a randomized, controlled trial. J Am Geriatr Soc. 2003;51(12):1685–1692. https://doi.org/10.1046/ j.1532-5415.2003.51551.x. 40. Barnett A, Smith B, Lord SR, Williams M, Baumand A. Community-based group exercise improves balance and reduces falls in at-risk older people: a randomised controlled trial. Age Ageing. 2003;32(4):407–414. https://doi.org/10.1093/ageing/ 32.4.407. 41. Hauer K, Rost B, R€ utschle K, et al. Exercise training for rehabilitation and secondary prevention of falls in geriatric patients with a history of injurious falls. J Am Geriatr Soc. 2001;49(1):10–20. https://doi.org/10.1046/j.1532-5415.2001.49004.x. 42. Serra-Rexach JA, Bustamante-Ara N, Hierro Villar an M, et al. Short-term, lightto moderate-intensity exercise training improves leg muscle strength in the oldest old: a randomized controlled trial. J Am Geriatr Soc. 2011;59(4):594–602. https:// doi.org/10.1111/j.1532-5415.2011.03356.x. 43. Lazkani A, Delespierre T, Bauduceau B, et al. Predicting falls in elderly patients with chronic pain and other chronic conditions. Aging Clin Exp Res. 2015;27(5):653–661. https://doi.org/10.1007/s40520-015-0319-2. 44. Nikolaus T, Bach M. Preventing falls in community-dwelling frail older people using a home intervention team (HIT): results from the randomized Falls-HITT trial. J Am Geriatr Soc. 2003;51(3):300–305. 45. Kumar A, Delbaere K, Zijlstra GAR, et al. Exercise for reducing fear of falling in older people living in the community: cochrane systematic review and meta-analysis. Age Ageing. 2016;45(3):345–352. https://doi.org/10.1093/ageing/afw036. 46. Porter Starr KN, McDonald SR, Bales CW. Obesity and physical frailty in older adults: a scoping review of intervention trials. J Am Med Dir Assoc. 2014;15 (4):240–250. https://doi.org/10.1016/j.jamda.2013.11.008. 47. Bowen ME. The relationship between body weight, frailty, and the disablement process. J Gerontol B Psychol Sci Soc Sci. 2012;67(5):618–626. https://doi.org/ 10.1093/geronb/gbs067. 48. Reinders I, Visser M, Schaap L. Body weight and body composition in old age and their relationship with frailty. Curr Opin Clin Nutr Metab Care. 2017;20(1):11–15. https://doi.org/10.1097/MCO.0000000000000332. 444 P. P erez-Ros et al. / Geriatric Nursing 41 (2020) 436444