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Effectiveness of a self-managed digital exercise programme to prevent falls in older community-dwelling adults: study protocol for the Safe Step randomised controlled trial.

ABSTRACT: INTRODUCTION:Exercise interventions have a strong evidence base for falls prevention. However, exercise can be challenging to implement and often has limited reach and poor adherence. Digital technology provides opportunities for both increased access to the intervention and support over time. Further knowledge needs to be gained regarding the effectiveness of completely self-managed digital exercise interventions. The main objective of this study is to compare the effectiveness of a self-managed digital exercise programme, Safe Step, in combination with monthly educational videos with educational videos alone, on falls over 1?year in older community-dwelling adults. METHODS AND ANALYSIS:A two-arm parallel randomised controlled trial will be conducted with at least 1400 community-living older adults (70+ years) who experience impaired balance. Participants will be recruited throughout Sweden with enrolment through the project website. They will be randomly allocated to either the Safe Step exercise programme with additional monthly educational videos about healthy ageing and fall prevention, or the monthly education videos alone. Participants receiving the exercise intervention will be asked to exercise at home for at least 30?min, 3 times/week with support of the Safe Step application. The primary outcome will be rate of falls (fall per person year). Participants will keep a fall calendar and report falls at the end of each month through a digital questionnaire. Further assessments of secondary outcomes will be made through self-reported questionnaires and a self-test of 30?s chair stand test at baseline and 3, 6, 9 and 12 months after study start. Data will be analysed according to the intention-to-treat principle. ETHICS AND DISSEMINATION:Ethical approval was obtained by The Regional Ethical Review Board in Umeå (Dnr 2018/433-31). Findings will be disseminated through the project web-site, peer-reviewed journals, national and international conferences and through senior citizen organisations' newsletters. TRIAL REGISTRATION NUMBER:NCT03963570.

SUBMITTER: Pettersson B

PROVIDER: S-EPMC7239551 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Effectiveness of a self-managed digital exercise programme to prevent falls in older community-dwelling adults: study protocol for the Safe Step randomised controlled trial.

Pettersson Beatrice B Lundin-Olsson Lillemor L Skelton Dawn A DA Liv Per P Zingmark Magnus M Rosendahl Erik E Sandlund Marlene M

BMJ open 20200517 5

<h4>Introduction</h4>Exercise interventions have a strong evidence base for falls prevention. However, exercise can be challenging to implement and often has limited reach and poor adherence. Digital technology provides opportunities for both increased access to the intervention and support over time. Further knowledge needs to be gained regarding the effectiveness of completely self-managed digital exercise interventions. The main objective of this study is to compare the effectiveness of a sel ...[more]

PMID: 32423936

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Project description:BackgroundStandingTall uses eHealth to deliver evidence-based balance and functional strength exercises. Clinical trials have demonstrated improved balance, reduced falls and fall-related injuries and high adherence. This study aimed to evaluate the implementation of StandingTall into health services in Australia and the UK.MethodsTwo hundred and forty-six participants (Australia, n = 184; UK, n = 62) were recruited and encouraged to use StandingTall for 2 h/week for 6-months. A mixed-methods process evaluation assessed uptake and acceptability of StandingTall. Adherence, measured as % of prescribed dose completed, was the primary outcome.ResultsThe study, conducted October 2019 to September 2021 in Australia and November 2020 to April 2022 in the UK, was affected by COVID-19. Participants' mean age was 73 ± 7 years, and 196 (81%) were female. Of 129 implementation partners (e.g. private practice clinicians, community exercise providers, community service agencies) approached, 34% (n = 44) agreed to be implementation partners. Of 41 implementation partners who referred participants, 15 (37%) referred ≥5. Participant uptake was 42% (198/469) with mean adherence over 6 months being 41 ± 39% of the prescribed dose (i.e. 39 ± 41 min/week) of exercise. At 6 months, 120 (76%) participants indicated they liked using StandingTall, 89 (56%) reported their balance improved (moderately to a great deal better) and 125 (80%) rated StandingTall as good to excellent. For ongoing sustainability, health service managers highlighted the need for additional resources.ConclusionsStandingTall faced challenges in uptake, adoption and sustainability due to COVID-19 and a lack of ongoing funding. Adherence levels were lower than the effectiveness trial, but were higher than other exercise studies. Acceptance was high, indicating promise for future implementation, provided sufficient resources and support are made available.Trial registrationAustralian and New Zealand Clinical Trials Registry ACTRN12619001329156.

Project description:BackgroundThe United States Preventive Services Task Force recommends exercise to prevent falls in community-dwelling adults aged ≥ 65 years at increased fall risk. However, little is known about how best to implement exercise programs in routine care when a patient's need for exercise is identified within the healthcare system.MethodsUsing a qualitative approach, we reviewed the literature to determine how exercise programs to prevent falls are implemented from the vantage point of a health care setting. We synthesized descriptive information about each program with data on program features and implementation difficulties and facilitators.ResultsWe found that programs sponsored by primary care providers (PCPs) or specialists may help with recruitment into exercise programs. PCPs have the opportunity to identify people at risk and promote participation since most older adults regularly visit, and inquire about exercise from, their physicians. In terms of referral options, both home-based and group-based exercise programs have been shown effective in preventing falls; however, each approach carries strengths and limitations. Home-based programs can include participants who are reluctant or unable to attend group classes and can be individually tailored, but provide less opportunity for supervision and socialization than classes. Adherence to programs can be encouraged, and attrition minimized, through positive reinforcement. Successful programs ranged in expense for exercise sessions: a weekly class combined with exercises at home cost < $2 per participant per week, while frequent individual sessions cost > $100 per participant per week.ConclusionsWith increasing attention to population-based health management in the United States, clinicians and health system leaders need a deeper understanding of how to link patients in their healthcare systems with appropriate community programs. This review identifies key characteristics of successful fall prevention exercise programs that can be used to determine which local options conform to clinical evidence. In addition, we highlight tradeoffs between program options, such as home versus group exercise programs, to allow referrals to be tailored to local conditions and patient preferences. Finally, our work highlights the key role of the PCP in recruiting patients to participate in exercise programs, and identifies options, such as registries, to support referrals to the community.

Project description:ObjectiveTo determine the effectiveness of a multifaceted podiatry intervention in preventing falls in community dwelling older people with disabling foot pain.DesignParallel group randomised controlled trial.SettingUniversity health sciences clinic in Melbourne, Australia.Participants305 community dwelling men and women (mean age 74 (SD 6) years) with disabling foot pain and an increased risk of falling. 153 were allocated to a multifaceted podiatry intervention and 152 to routine podiatry care, with 12 months' follow-up.InterventionsMultifaceted podiatry intervention consisting of foot orthoses, advice on footwear, subsidy for footwear ($A100 voucher; £65; €74), a home based programme of foot and ankle exercises, a falls prevention education booklet, and routine podiatry care for 12 months. The control group received routine podiatry care for 12 months.Main outcome measuresProportion of fallers and multiple fallers, falling rate, and injuries resulting from falls during follow-up.ResultsOverall, 264 falls occurred during the study. 296 participants returned all 12 calendars: 147 (96%) in the intervention group and 149 (98%) in the control group. Adherence was good, with 52% of the participants completing 75% or more of the requested three exercise sessions weekly, and 55% of those issued orthoses reporting wearing them most of the time. Participants in the intervention group (n=153) experienced 36% fewer falls than participants in the control group (incidence rate ratio 0.64, 95% confidence interval 0.45 to 0.91, P=0.01). The proportion of fallers and multiple fallers did not differ significantly between the groups (relative risk 0.85, 0.66 to 1.08, P=0.19 and 0.63, 0.38 to 1.04, P=0.07). One fracture occurred in the intervention group and seven in the control group (0.14, 0.02 to 1.15, P=0.07). Significant improvements in the intervention group compared with the control group were found for the domains of strength (ankle eversion), range of motion (ankle dorsiflexion and inversion/eversion), and balance (postural sway on the floor when barefoot and maximum balance range wearing shoes).ConclusionsA multifaceted podiatry intervention reduced the rate of falls in community dwelling older people with disabling foot pain. The components of the intervention are inexpensive and relatively simple to implement, suggesting that the programme could be incorporated into routine podiatry practice or multidisciplinary falls prevention clinics.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12608000065392.

Project description:IntroductionFalls have major implications for quality of life, independence, and cost of health services. Strength and balance training has been found to be effective in reducing the rate/risk of falls, as long as there is adequate fidelity to the evidence-based programme. The aims of this study were to (1) assess the feasibility of using the "Motivate Me" and "My Activity Programme" interventions to support falls rehabilitation when delivered in practice and (2) assess study design and trial procedures for the evaluation of the intervention.MethodsA two-arm pragmatic feasibility randomized controlled trial was conducted with five health service providers in the UK. Patients aged 50+ years eligible for a falls rehabilitation exercise programme from community services were recruited and received either (1) standard service with a smartphone for outcome measurement only or (2) standard service plus the "Motivate Me" and "My Activity Programme" apps. The primary outcome was feasibility of the intervention, study design, and procedures (including recruitment rate, adherence, and dropout). Outcome measures include balance, function, falls, strength, fear of falling, health-related quality of life, resource use, and adherence, measured at baseline, three-month, and six-month post-randomization. Blinded assessors collected the outcome measures.ResultsTwenty four patients were randomized to control group and 26 to intervention group, with a mean age of 77.6 (range 62-92) years. We recruited 37.5% of eligible participants across the five clinical sites. 77% in the intervention group completed their full exercise programme (including the use of the app). Response rates for outcome measures at 6 months were 77-80% across outcome measures, but this was affected by the COVID-19 pandemic. There was a mean 2.6 ± 1.9 point difference between groups in change in Berg balance score from baseline to 3 months and mean 4.4 ± 2.7 point difference from baseline to 6 months in favour of the intervention group. Less falls (1.8 ± 2.8 vs. 9.1 ± 32.6) and less injurious falls (0.1 ± 0.5 vs. 0.4 ± 0.6) in the intervention group and higher adherence scores at three (17.7 ± 6.8 vs. 13.1 ± 6.5) and 6 months (15.2 ± 7.8 vs. 14.9 ± 6.1). There were no related adverse events. Health professionals and patients had few technical issues with the apps.ConclusionsThe motivational apps and trial procedures were feasible for health professionals and patients. There are positive indications from outcome measures in the feasibility trial, and key criteria for progression to full trial were met.

Project description:BackgroundPhysical and cognitive impairments are important risk factors for falls in older people. However, no studies have been adequately powered to examine whether cognitive or cognitive-motor training can prevent falls in older people. This is despite good evidence of improvements in fall-related cognitive and physical functions following both intervention types. This manuscript describes the study protocol for a three-arm randomised controlled trial to evaluate the effectiveness of home-based cognitive and cognitive-motor training interventions, compared to a minimal-intervention control group, in preventing falls in older people. This trial was prospectively registered with the Australia New Zealand Clinical Trial Registry, number ACTRN12616001325493.Methods and analysisCommunity-dwelling adults aged 65 years and over, residing in Sydney Australia, will be recruited. Participants (n=750) will be randomly allocated to (1) cognitive-only training, (2) cognitive-motor training or (3) control groups. Both training interventions involve the use of the smart±step home-based computerised game playing system for a recommended 120 min/week for 12 months. Cognitive training group participants will use a desktop electronic touch pad to play games with the smart±step system while seated and using both hands. The cognitive-motor training group participants will use a wireless electronic floor step mat that requires accurate stepping using both legs for playing the same smart±step games, hence incorporating balance exercises. All groups will receive an education booklet on fall prevention. The primary outcome will be rate of falls, reported by monthly diaries during the 12-month duration of the study and analysis will be by intention-to-treat. Secondary outcomes include the proportion of fallers, physical and cognitive performance in 300 participants, and brain structure and function in 105 participants who will undertake MRI scans at baseline and 6 months. Cost-effectiveness will be determined using intervention and health service costs.Ethics and disseminationEthical approval was obtained from UNSW Ethics Committee in September 2015 (ref number HC15203). Outcomes will be disseminated through publication in peer-reviewed journals and presentations at international conferences.Trial registration numberACTRN12616001325493.

Project description:IntroductionFalls have major implications for quality of life, independence and cost to the health service. Strength and balance training has been found to be effective in reducing the rate/risk of falls, as long as there is adequate fidelity to the evidence-based programme. Health services are often unable to deliver the evidence-based dose of exercise and older adults do not always sufficiently adhere to their programme to gain full outcomes. Smartphone technology based on behaviour-change theory has been used to support healthy lifestyles, but not falls prevention exercise. This feasibility trial will explore whether smartphone technology can support patients to better adhere to an evidence-based rehabilitation programme and test study procedures/outcome measures.Methods and analysisA two-arm, pragmatic feasibility randomised controlled trial will be conducted with health services in Manchester, UK. Seventy-two patients aged 50+years eligible for a falls rehabilitation exercise programme from two community services will receive: (1) standard service with a smartphone for outcome measurement only or (2) standard service plus a smartphone including the motivational smartphone app. The primary outcome is feasibility of the intervention, study design and procedures. The secondary outcome is to compare standard outcome measures for falls, function and adherence to instrumented versions collected using smartphone. Outcome measures collected include balance, function, falls, strength, fear of falling, health-related quality of life, resource use and adherence. Outcomes are measured at baseline, 3 and 6-month post-randomisation. Interviews/focus groups with health professionals and participants further explore feasibility of the technology and trial procedures. Primarily analyses will be descriptive.Ethics and disseminationThe study protocol is approved by North West Greater Manchester East Research Ethics Committee (Rec ref:18/NW/0457, 9/07/2018). User groups and patient representatives were consulted to inform trial design, and are involved in study recruitment. Results will be reported at conferences and in peer-reviewed publications. A dissemination event will be held in Manchester to present the results of the trial. The protocol adheres to the recommended Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist.Trial registration numberISRCTN12830220; Pre-results.

Dataset Information

Effectiveness of a self-managed digital exercise programme to prevent falls in older community-dwelling adults: study protocol for the Safe Step randomised controlled trial.

Publications

Effectiveness of a self-managed digital exercise programme to prevent falls in older community-dwelling adults: study protocol for the Safe Step randomised controlled trial.

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