Effect of 12-month supervised, home-based physical exercise on functioning among persons with signs of frailty : Randomized Controlled Trial

This is a self-archived version of an original article. This version may differ from the original in pagination and typographic details. Author(s): Title: Year: Version: Copyright: Rights: Rights url: Please cite the original version: CC BY-NC-ND 4.0 https://creativecommons.org/licenses/by-nc-nd/4.0/ Effect of 12-month supervised, home-based physical exercise on functioning among persons with signs of frailty : Randomized Controlled Trial © 2021 The American Congress of Rehabilitation Medicine Accepted version (Final draft) Suikkanen, Sara; Soukkio, Paula; Aartolahti, Eeva; Kääriä, Sanna; Kautiainen, Hannu; Hupli, Markku T.; Pitkälä, Kaisu; Sipilä, Sarianna; Kukkonen-Harjula, Katriina Suikkanen, S., Soukkio, P., Aartolahti, E., Kääriä, S., Kautiainen, H., Hupli, M. T., Pitkälä, K., Sipilä, S., & Kukkonen-Harjula, K. (2021). Effect of 12-month supervised, home-based physical exercise on functioning among persons with signs of frailty : Randomized Controlled Trial. Archives of Physical Medicine and Rehabilitation, 102(12), 2283-2290. https://doi.org/10.1016/j.apmr.2021.06.017 2021 Running head: Physical exercise, functioning & frailty 1 Title: Effect of 12-month supervised, home-based physical exercise on functioning among persons 2 with signs of frailty – Randomized Controlled Trial 3 Authors: 4 Sara Suikkanena,b MSc, [email protected] 5 Paula Soukkioa,b MSc, [email protected] 6 Eeva Aartolahtib PhD, [email protected] 7 Sanna Kääriäc PhD, [email protected] 8 Hannu Kautiainend BA, [email protected] 9 Markku T. Huplia MD, PhD, [email protected] 10 Kaisu Pitkäläd MD, PhD, [email protected] 11 Sarianna Sipiläb,e PhD, [email protected] 12 Katriina Kukkonen-Harjulaa MD, PhD, [email protected] 13 Affiliations: 14 a South Karelia Social and Health Care District, Rehabilitation, Valto Käkelän katu 3, FI-53130 15 Lappeenranta, FINLAND 16 b University of Jyväskylä, Faculty of Sport and Health Sciences, PO Box 35, FI-40014 University of 17 Jyväskylä, FINLAND 18 c Raatimiehet Oy, Raatimiehenkatu 18, FI-53100, Lappeenranta, FINLAND 19 d University of Helsinki, Department of General Practice, and Helsinki University Hospital, Unit of 20 Primary Health Care, Tukholmankatu 8 B, FI-00290 Helsinki, FINLAND 21 e University of Jyväskylä, Gerontology Research Center, Faculty of Sport and Health Sciences, 22 Rautpohjankatu 8, FI-40700 Jyväskylä, FINLAND 23 2 Acknowledgments 24 Meeting presentation: Presented as a poster at the International Association of Geriatrics and 25 Gerontology-European Region Congress in Gothenburg, Sweden on May 25, 2019, and in the 26 European Geriatric Medicine Society in Krakow, Poland on September 27, 2019. 27 Funding: This work was supported by the South Karelia Social and Health Care District (Eksote; 28 register number 1236/00.01.05.01/2013); The Social Insurance Institution of Finland (SII; register 29 number 94/331/2013); and the Finland State Research Funding for Academic Health Research 30 (Ministry of Social Affairs and Health). The funders played no role in the design, collection, 31 analysis, or interpretation of the data, nor in writing the manuscript. 32 33 Conflicts of interest disclosure: Authors declare no conflicts of interest 34 35 Corresponding author: 36 Sara A. Suikkanen, MSc. 37 address: PO Box 35, FI-40014 University of Jyväskylä, FINLAND 38 phone: +358 504301870 39 e-mail: sara.a.[email protected] 40 41 No preprints available 42 43 Trial Registration: ClinicalTrials.gov, NCT02305433 44 45 3 Author contributions: Concept and design: Hupli, Kääriä, Kukkonen-Harjula, Soukkio, Suikkanen, 46 Pitkälä, Sipilä. Acquisition, analysis or interpretation of data: All authors. Drafting of the manuscript: 47 Suikkanen. Critical revision of the manuscript for important intellectual content: All authors. 48 Statistical analyses: Kautiainen, Suikkanen. Obtained funding: Hupli, Kääriä, Kukkonen-Harjula, 49 Soukkio and Suikkanen. Final approval of the version to be published: All authors. 50 Additional contributions: We would like to thank Ms. Kaija Paajanen, and Ms. Virpi Äärimaa for 51 their valuable contribution to study recruitment and data collection. We would also like to thank 52 the South Karelia Social and Health Care District´s (Eksote) personnel for their contribution in 53 recruiting participants. 54 55 ABSTRACT 56 Objectives: To investigate the effects of a 12-month home-based exercise program on functioning 57 and falls among persons with signs of frailty. 58 59 Design: A randomized controlled trial with a 1:1 allocation 60 61 Setting: Home-based 62 63 Participants: Home-dwelling persons aged >65 years meeting at least one frailty phenotype 64 criteria (n=300). 65 66 Intervention: 12-month, individually tailored, progressive and physiotherapist-supervised, physical 67 exercise twice a week (n=150) vs. usual care (n=149). 68 4 69 Main outcome Measures: Functional Independence Measure (FIM), Short Physical Performance 70 Battery (SPPB), handgrip strength, instrumental activities of daily living (IADL), and self-reported 71 falls and physical activity (other than intervention). Assessed four times at home over 12 months. 72 73 Results: The mean age of the participants was 82.2 (SD 6.3), 75% were women, 61% met 1–2 74 frailty criteria and 39% ≥3 criteria. FIM deteriorated in both groups over 12 months, -4.1 points 75 (95% CI: -5.6 to -2.5) in the exercise group and -6.9 (-8.4 to -2.3) in the usual care group (group 76 p=0.014, time p<0.001, interaction p=0.56). The mean improvement in SPPB was significantly 77 greater in the exercise group [1.6 (1.3 to 2.0)] than in the usual care group [0.01 (-0.3 to 0.3)] 78 (group p<0.001, time p=0.11, interaction p=0.027). The exercise group reported significantly fewer 79 falls per person-year compared to the usual care group (incidence rate ratio, IRR 0.47 [95% CI 0.40 80 to 0.55]; p<0.001). There was no significant difference between the groups over 12 months in 81 terms of handgrip strength, IADL function or self-reported physical activity. 82 83 Conclusions: One year of physical exercise improved physical performance and decreased the 84 number of falls among people with signs of frailty. FIM differed between the groups at 12 months, 85 but exercise did not prevent deterioration of FIM, IADL or handgrip strength. 86 87 Keywords: physical therapy, physical functional performance, functional status, falls, aging 88 89 List of abbreviations: CI Confidence Interval, FDR False Discovery Rate, FIM Functional 90 Independence Measure, FRAIL Fatigue, Resistance, Ambulation, Illnesses, Loss of weight, IADL 91 5 Instrumental Activities of Daily Living, IQR Inter-Quartile Range, IRR Incidence Rate Ratio, MMSE 92 Mini-mental State Examination, NYHA New York Heart Association, RCT Randomized Controlled 93 Trial, SPPB Short Physical Performance Battery 94 95 96 6 Frailty is a syndrome which occurs especially in older adults1 and is often associated with 97 sarcopenia2. People with frailty often suffer from impaired functioning, and diminished muscle 98 strength and endurance3,4 and frailty increase the risk of disability and falls.5 Physical frailty can be 99 defined via five phenotypic criteria: weight loss, weakness, slowness, low physical activity, and 100 exhaustion.6 101 102 Physical exercise is a promising treatment option for frailty.3,7,8 Group-based exercise training for 103 frail older adults has shown positive effects on physical performance9,10 and physical activity can 104 postpone harmful consequences8 such as disabilities, falls and mortality.3,4,6 The strongest 105 evidence comes from multicomponent training programs with resistance training as the central 106 component, accompanied by aerobic, balance and flexibility exercises.8,11 107 108 Even though physical exercise is a treatment option for frailty, persons with signs of frailty may 109 think that they lack the capacity to be physically active.12 The barrier to participate in physical 110 activities may be lowered by providing opportunities to instructed exercise near their own 111 homes.12 Supervised home-based training might be a valuable option for frail older adults but 112 evidence on its effectiveness is still scarce. Previous home-based exercise trials targeting frail older 113 adults have consisted of interventions of a maximum of six months with limited supervision from 114 professionals and inconclusive results.13 115 116 The aim of this randomized trial was to investigate the effects of a 12-month physiotherapist- 117 supervised, home-based exercise program on functioning and falls among people with signs of 118 frailty, in comparison with usual care. 119 120 7 121 METHODS 122 123 124 Study design 125 126 127 This article reports secondary outcomes of our trial which was registered to ClinicalTrials.gov 128 (NCT02305433) prior to recruitment. The study protocol has been published,14 and the primary 129 outcome, days lived at home, has been reported earlier.15 In short, we performed a parallel, 130 randomized clinical trial, with a 1:1 allocation ratio. After the baseline assessments, the research 131 personnel randomized participants into two groups, using a computer-generated random 132 sequence allocation program with randomly varying block sizes from 2 to 10, without 133 stratification. A statistician, who had no role in the trial, created the randomization program. One 134 person in the research group used the randomization program and informed the participants of 135 their allocation by phone. The allocation groups were a physiotherapist-supervised physical 136 exercise group (n=150) and a usual care group (n=150). 137 138 139 Participants 140 141 142 Home-dwelling individuals aged >65 years were recruited between December 2014 and August 143 2016, via advertisements in newspapers and with the help of the home healthcare personnel of 144 8 the social and health care district. To be eligible, the individuals needed to pass through a two- 145 phase recruitment process and had to fulfill at least one phenotype criterium of frailty. First, they 146 were evaluated using the FRAIL questionnaire.16,17 FRAIL has five domains with one point each: 147 Fatigue (feeling tired all the time or most of the time), Resistance (unable to climb 1 flight of 148 stairs), Ambulation (unable to walk 1 block), Illnesses (more than 5), Loss of weight (>5% during 149 the previous years). If a person scored at least one point in FRAIL they advanced to the second 150 phase, where the research nurse checked their eligibility criteria and verified their frailty status 151 using Fried et al.´s phenotype criteria6 with slight modifications. The criteria used were: weight 152 loss ≥5% during the preceding year6, physical activity under 30 minutes/week18, a feeling of “not 153 getting going” or “everything is an effort” for most or all of the time6, handgrip strength under cut- 154 off values based on BMI and gender6, and walking speed under 0.46 m/s (walking length either 4 155 or 2.44 m)19. 156 157 Other eligibility criteria were residing at home, ability to walk indoors with or without mobility 158 aids, scoring ≥17 in Mini-Mental State Examination (MMSE) test,20 and the ability to communicate 159 in Finnish. Individuals were excluded if they were living in an institutional care facility or nursing 160 home, or had alcohol or drug abuse problems, severe problems with hearing or eyesight, terminal 161 illnesses (e.g., cancers), or other severe illnesses (e.g., a cardiovascular disease with New York 162 Heart Association Functional Classification class III or IV, severe pulmonary disease or a stroke) 163 that was contraindication to physical exercise. The study received ethics approval on November 164 12, 2014 from the Coordinating Ethics Committee and was conducted in accordance with the 165 standards of the Helsinki declaration. All the participants were volunteers and signed a written 166 informed consent document prior to the baseline assessments. 167 168 15 Over 12 months, all motor and cognitive components of FIM deteriorated in both of our groups. 310 The FIM evaluates a person’s need for care in everyday tasks and has mainly been used in 311 inpatient rehabilitation.21 We assessed FIM by an interview at the person´s home. Only a few 312 other studies have used FIM in outpatient settings among older adults. In two Finnish studies, FIM 313 was used to measure the change over 12 months among older people at risk of 314 institutionalization, (AGE study),28 and people with Alzheimer´s disease, (FINALEX study).29 In both 315 studies, FIM deteriorated in the intervention and usual care groups, like in our study, and among 316 the people in the intervention groups, deterioration was slower. The AGE28 and FINALEX29 317 participants were on average a few years younger than those in our sample, and the FINALEX 318 study used a home-based intervention29 similar to ours. Some of our participants might have been 319 unable to improve their FIM scores because of the aids they used at home (e.g., dentures, walking 320 aids, shower handles, raised beds, use of a banister) and which they were unwilling or unable to 321 discard. 322 323 Because SPPB predicts nursing home admissions19 and all-cause mortality,30 and is a fast and easy 324 way to measure physical performance, it is widely used in clinical practices. In our trial, SPPB 325 improved in the exercise group by 1.6 points over 12 months, which can be considered clinically 326 important. In previous studies a substantially clinical meaningful change in SPPB has been 327 estimated to range from 0.4 to 1.5 points,31 and from 0.5 to 1.3 points.32 In community-living older 328 adults with frailty, group-based supervised exercise training of 24 weeks improved their SPPB 329 score by 0.9 points, whereas that of the usual care group deteriorated by 1.5 points.10 In all these 330 studies10,31-33 the participants had better baseline SPPB scores than ours. Among frail nursing 331 home residents34 with a similar SPPB baseline level to ours, a six-month progressive 332 16 multicomponent group-based exercise intervention improved the mean SPPB score by 1.8 points, 333 whereas the mean score in the control group declined by 0.9 points. 334 335 Another important gain was the smaller number of falls in our exercise group than in the usual 336 care group. We based our intervention on the exercises from the OTAGO exercise program, which 337 effectively reduced the number of falls among community-dwelling older adults.35 An Italian cross- 338 sectional study on older outpatients in a geriatric clinic36 found an association between lower SPPB 339 scores and history of falls. In our trial, no severe complications occurred; only one injurious fall 340 during exercise session needed medical care. 341 342 Our physical exercise intervention included brief counselling on physical activity as 343 physiotherapists encouraged the participants to be active outside the supervised sessions. Even 344 though the usual care group received no counseling, both groups increased their number of 345 physical activity sessions per week in the first half of the trial. However, both groups decreased 346 back to baseline level in the later half. 347 348 Training with the physiotherapists at home enabled people also in rural areas to participate in our 349 study. Adherence to home-based programs has been better than in center-based programs,37 as 350 older adults prefer activities close to home.12 Furthermore, the effects of supervised home-based 351 training on strength and functional ability have been greater,38,39 and the intensity of the sessions 352 can be higher40 than in training without supervision. In our trial, supervision meant higher 353 intervention expenses, but in the subgroup of frail participants, there was a decrease in total costs 354 of social and health care services over 24 months compared to the frail participants in the usual 355 care.15 356 17 357 As a strength, our study was a rigorously performed RCT with good compliance. Furthermore, our 358 sample was identified as frail or pre-frail at baseline41 based on two validated frailty 359 assessments.6,16 We also used validated measurements to assess functioning and physical 360 performance, and the proportion of missing measurements during the intervention year was very 361 low (13% at 12 months). 362 363 364 Study limitations 365 366 Falls and physical activity were self-reported, which is more unreliable than diaries42 and objective 367 measurements.43 Our validated questions24 included only frequencies of physical activities lasting 368 over 30 minutes but neither intensity nor exact duration. Therefore, our findings regarding falls 369 and physical activity are only indicative and need to be interpreted with caution. In addition, the 370 assessors were not blinded to the allocation status of the participants. 371 372 373 CONCLUSION 374 375 376 In conclusion, among people with signs of frailty, 12-month supervised, home-based exercise 377 improved SPPB and decreased the number of falls. At 12 months, the physical exercise group had 378 a better FIM than the usual care group, but there was no difference in IADL or handgrip strength 379 between the groups. Supervised exercise did not enhance physical activity during leisure time. 380 18 SUPPLIERS 381 aSaehan, model Sh5001, South Korea 382 b Stata 16.1, StataCorp LP, College Station, TX, USA 383 384 385 REFERENCES 386 1. Fried LP, Ferrucci L, Darer J, Williamson JD, Anderson G. Untangling the concepts of disability, frailty, 387 and comorbidity: Implications for improved targeting and care. J Gerontol A Biol Sci Med Sci. 388 2004;59(3):255-263. doi:10.1093/gerona/59.3.m255 389 2. Cruz-Jentoft AJ, Sayer AA. Sarcopenia. 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A comparison of direct versus self-report measures for assessing 503 physical activity in adults: a systematic review. Int J Behav Nutr Phys Act. 2008;5:56. 504 doi.org/10.1186/1479-5868-5-56 505 44. Gardner MM, Bucher DM, Robertson MC, Cambell AJ. Practical implementation of an exercise-based 506 falls prevention programme. Age Ageing. 2001;30:70-83. 507 508 509 21 Figures and tables 510 511 512 Figure 1. Flowchart of participants in randomized clinical trial. Numbers of participants. 513 514 Figure 2. Mean changes in Functional Independence Measure (FIM) (A), and in Short Physical 515 Performance Battery (SPPB) (B), and mean weekly frequency of physical activity sessions (C) in 516 physical exercise and usual care groups over 12 months. Whiskers denote 95% confidence 517 intervals. 518 519 Figure 3. Mean changes in FIM items in the physical exercise and usual care groups from 0 to 12 520 months. Whiskers denote 95% confidence intervals. Benjamin-Hochberg step-up false discovery 521 rate was applied to correct levels of significance for multiple testing in single FIM items. 522 523 Table 1. Contents of one 60-minute physical exercise session, supervised by physiotherapist. 524 525 Table 2. Baseline characteristics of participants in physical exercise and usual care groups. Means 526 (SD) and frequencies (%). 527 Table 1. Contents of one 60-minute physical exercise session, supervised by a physiotherapist. 528 Warm-up exercises Resistance training Balance training Flexibility training Functional exercises Counseling Duration 5–10 minutes 30–40 minutes 5–10 minutes 5–10 minutes 5–10 minutes Individual Main exercises Walking, chair exercises, stationary cycling Focus on lower limbs, main exercises based on Otago program.44 Exercises included e.g., knee extension, knee flexion, hip abduction, calf raises, toe raises. Upper limbs: no specific movements assigned. Static, dynamic, and dual task exercises based on Otago program44, e.g., tandem stand, squats, walking in various directions. Stretching, reaching Tasks of IADL* such as climbing stairs, washing dishes, handling laundry, piling firewood, walking outside, grocery shopping Nutrition: energy intake, protein intake, meal pattern, fluid intake Physical activity counseling and encouragement Intensity Low to moderate Moderate to vigorous Moderate Low Moderate to vigorous Individual RPE † 26 10–12 12–17 12–14 10–11 12–17 Progression Longer distance or more challenging terrain, or e.g., higher resistance in the stationary cycle Increasing the number of sets, repetitions, and resistance with ankle weights to match the targeted RPE and the phase of the training cycle: 1st mo.‡ getting used to exercises; 2nd to 3rd mo. strength (sets 2– 5, reps§. 8–12, 60-80% of maximum muscle strength according to multiple RM- test45); 4th to 6th mo. power (sets 3–5, reps 4–10, 20-60%); 7th to 9th mo. endurance (sets 2-3, reps. 12-30, 20-60%); 10th to 12th mo. strength/power. More challenging surfaces and tasks to challenge the participant’s balance. Starting from static exercises, progressing to dynamic and dualtask exercises Larger range of motion Advancing to more challenging tasks and combined with strength and balance training From broad and general to the more specific Accessories Walking aid (if needed), fitness equipment e.g., stationary bike Resistance with ankle weights from 0.5 kg to 10 kg, dumbbells, kettlebells, rubber bands Balance pads, different types of floor surfaces, outdoor environment Stick Natural home environment Pamphlets and booklets Goal To warm-up and prepare the body before other exercises To increase the strength of lower limbs and to enhance physical performance To challenge individual balance abilities, to prevent falls To enlarge the range of motion in large joints to maintain ADL|| To support individual abilities to live independently at home To provide knowledge and motivate to follow nutrition and exercise guidelines *IADL, Activities of Daily Living; † RPE, Ratings of Perceived Exertion26; ‡ mo., month(s); § reps., repetitions; || ADL, Activities of Daily Living 529 Table 2. Baseline characteristics of participants in physical exercise and usual care groups. Means 530 (SD) and frequencies (%). 531 Characteristic Physical exercise (n=150) Usual care (n=149) Age (years), mean (SD) 82.2 (6.3) 82.7 (6.3) Women, n (%) 114 (76) 110 (74) Number of frailty criteria a, n (%) 1 44 (29) 48 (32) 2 48 (32) 44 (30) 3 40 (27) 42 (28) 4 13 (9) 13 (9) 5 5 (3) 2 (1) Mini-Mental State Examination (MMSE)b, mean (SD) 24.2 (3.1) 24.6 (3.2) Functional Independence Measure (FIM)c, mean (SD) 109 (10) 109 (11) Instrumental Activities of Daily Living (IADL)d, mean (SD) 23 (5) 23 (6) Short Physical Performance Battery (SPPB)e, mean (SD) 6.1 (2.7) 6.3 (2.5) Handgrip strengthf (kg), mean (SD) 18.9 (7.8) 19.7 (7.8) Living alone, n (%) 88 (59) 86 (58) Walking aids, n (%) 122 (81) 117 (79) Number of regular medications, mean (SD) 6.7 (3.2) 7.0 (3.1) Note. a According to modified Fried et al.’s4 phenotype criteria; b Points range from 0 to 30, a higher value indicating 532 better cognition; c Points range from 18 to 126, a higher score indicating better functional independence; d Reported 533 as an item sum, (points range from 8 to 31); a higher score indicates better functioning; e Scores range from 0 to 12, a 534 higher score indicates better performance; f Mean of best values of both hands. 535 536 537 24 Figure 1. Flowchart of participants in randomized clinical trial. Numbers of participants. 538 539