Dataset Information

Testing the feasibility of a primary-care exercise intervention to prevent and reverse early frailty and build resilience in community-dwelling older adults.

ABSTRACT:

Background

Resistance exercises have been shown to prevent and reverse frailty but their application in clinical practice is low. We wished to test the feasibility of an optimised exercise intervention for mild or pre-frailty in a primary-care setting and inform the design of a definitive randomised control trial.

Methods

The intervention was co-designed with eighteen older adults in two group workshops, informed by systematic review and meta-analysis. Eligible patients aged 65+, mildly frail or less, presenting to an Irish primary-care centre over 6 months from January 2020 were invited to participate. They were offered an exercise guide and educational discussion. Demographics, health indicators and frailty scores were recorded. Feasibility was assessed using the Bowen model for acceptability; participation; demand; implementation; practicality; adaptation; integration; expansion; and limited-efficacy. Half of the randomly selected participants were telephoned after one month, and all the participants were called after two to measure effects on adherence.

Findings

94 of 107 eligible people (88%) participated (average age 77, 59 women (63%)). Only 15% had previously considered resistance exercises. The intervention satisfied all Bowen feasibility criteria. At one month, 65% of participants were exercising. At two months, adherence amongst those previously called was higher: 78%. 87% described exercises as 'very easy' or 'somewhat easy'. 66% felt 'much better' or 'slightly better'.

Interpretation

Frailty intervention uptake and adherence were high. A single telephone call appeared to help increase adherence. Participants reported meaningful physical and mental health benefits.

Funding

Roman Romero-Ortuno is funded by a grant from Science Foundation Ireland (SFI), grant number 18/FRL/6188.

SUBMITTER: Travers J

PROVIDER: S-EPMC8943408 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature

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Publications

Testing the feasibility of a primary-care exercise intervention to prevent and reverse early frailty and build resilience in community-dwelling older adults.

Travers John J Romero-Ortuno Roman R Cooney Marie-Therese MT

EClinicalMedicine 20220322

<h4>Background</h4>Resistance exercises have been shown to prevent and reverse frailty but their application in clinical practice is low. We wished to test the feasibility of an optimised exercise intervention for mild or pre-frailty in a primary-care setting and inform the design of a definitive randomised control trial.<h4>Methods</h4>The intervention was co-designed with eighteen older adults in two group workshops, informed by systematic review and meta-analysis. Eligible patients aged 65+, ...[more]

PMID: 35340628

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Project description:BackgroundThe Coronavirus (COVID-19) pandemic has exacerbated the risk for poor physical and mental health outcomes among vulnerable older adults. Multicomponent interventions could potentially prevent or reduce the risk of becoming frail; however, there is limited evidence about utilizing alternative modes of delivery where access to in-person care may be challenging. This randomized feasibility trial aimed to understand how a multicomponent rehabilitation program can be delivered remotely to vulnerable older adults with frailty during the pandemic.MethodsParticipants were randomized to either a multimodal or socialization arm. Over a 12-week intervention period, the multimodal group received virtual care at home, which included twice-weekly exercise in small group physiotherapy-led live-streamed sessions, nutrition counselling and protein supplementation, medication consultation via a videoconference app, and once-weekly phone calls from student volunteers, while the socialization group received only once-weekly phone calls from the volunteers. The RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) framework was used to evaluate the feasibility of the program. The main clinical outcomes were change in the 5-times sit-to-stand test (5 × STS) and Depression, Anxiety and Stress Scale (DASS-21) scores. The feasibility outcomes were analyzed using descriptive statistics and expressed as frequencies and mean percent with corresponding confidence intervals (CI). Analysis of covariance (ANCOVA) was used for the effectiveness component.ResultsThe program enrolled 33% (n = 72) of referrals to the study (n = 220), of whom 70 were randomized. Adoption rates from different referral sources were community self-referrals (60%), community organizations (33%), and healthcare providers (25%). At the provider level, implementation rates varied from 75 to 100% for different aspects of program delivery. Participant's adherence levels included virtual exercise sessions 81% (95% CI: 75-88%), home-based exercise 50% (95% CI: 38-62%), protein supplements consumption 68% (95% CI: 55-80%), and medication optimization 38% (95% CI: 21-59%). Most participants (85%) were satisfied with the program. There were no significant changes in clinical outcomes between the two arms.ConclusionThe GERAS virtual frailty rehabilitation study for community-dwelling older adults living with frailty was feasible in terms of reach of participants, adoption across referral settings, adherence to implementation, and participant's intention to maintain the program. This program could be feasibly delivered to improve access to socially isolated older adults where barriers to in-person participation exist. However, trials with larger samples and longer follow-up are required to demonstrate effectiveness and sustained behavior change.Trial registrationClinicalTrials.gov NCT04500366. Registered August 5, 2020, https://clinicaltrials.gov/ct2/show/NCT04500366.

Project description:Introduction: Resistance exercises and dietary protein have been shown to reverse frailty, yet they are not commonly offered in clinical practice. We aim to measure changes in health outcomes, including physical frailty status (SHARE-FI), clinical frailty status (CFS) and muscle mass, as a result of an optimised exercise and dietary intervention versus usual care in a primary care (PC) setting. The intervention has been derived from our systematic review and meta-analysis findings and optimised through patient and public involvement and multidisciplinary team input. Methods: This study is a multicentre randomised controlled parallel arm trial with a three month follow up. 210 eligible people aged 65 and over, no more than mildly frail, will be recruited in seven PC practices in Ireland and randomly assigned to 'intervention' or 'usual care'. Intervention participants will be provided a leaflet with strength exercises, protein dietary guidance and educational discussion. Baseline measurements will include demographics, health indicators, comorbidities, malnutrition universal screening tool (MUST), frailty status (SHARE-FI, CFS) and muscle mass (bioelectrical impedance). Primary outcome will be frailty status measured by SHARE-FI at three months. Secondary outcomes include CFS, muscle mass, in-patient hospitalisation, long term care admission, and subjective ease of intervention and difference to general health. Statistical analysis will be undertaken by an independent statistician. Discussion: The diversity of tested frailty interventions and lack of clear guidance may contribute to low implementation rates. The REFEREE trial focusses on an optimised intervention for a syndrome that poses growing individual and societal challenges. It is hoped results can encourage mainstream adoption of interventions to reverse clinical frailty and build resilience in primary care. Trial registration: ClinicalTrials.gov ID NCT04628754; registered on 13 November 2020.

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:BackgroundExercise is effective in preventing frailty status in older adults, but the effect of an exercise program based on Wellness Motivation Theory (WMT) on the frailty status, self-efficacy for exercise, and quality of life for older adults with pre-frailty remains unclear. Our objective was to examine the efficacy of a multicomponent exercise program based on WMT on frailty status, self-efficacy, and quality of life among pre-frail older adults.MethodsThis was a randomized controlled trial of pre-frail older adults aged from 60 years to 85 years. Participants in the intervention group performed exercise three times a week for 24 weeks, once at a community health service station instructed by two researchers and two times at home. Participants in the control group were given one-time advice on physical activity. The assessor was the only one blinded. The primary outcome was the reversal rate of pre-frailty. The secondary outcomes included self-efficacy and quality of life.ResultsOne hundred and forty-four participants were randomized into two groups (n = 72 in the intervention group and n = 72 in the control group) and analyzed. After 24 weeks, the proportion of pre-frailty was significantly lower in the intervention group than in control (31.8% versus 74.6%, P < 0.001). The absolute risk reduction was 42.8% [95% CI, 25.1-57.1]. In the 8th week and the 24th week, the frailty score of the intervention group was significantly lower than that of the control group. There were significant improvements in self-efficacy at week 2, week 8, and week 24. In weeks 8 and 24, participants in the intervention group reported a higher quality of life than the control group. There were no exercise-related injuries or falls among the participants.ConclusionsThe exercise intervention based on WMT for pre-frail older adults could reverse pre-frailty, increase self-efficacy for exercise, and improve the quality of life in older Chinese.Study registration detailsThis study was registered in www.Clinicaltrialsgov on the 25th of July, 2024, with the identifier NCT06519695.Reporting methodThe Consolidated Standards of Reporting Trials (CONSORT) checklist was used in this study for properly reporting how the randomized trial was conducted.

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.

Project description:IntroductionFrailty refers to a multifaceted age-related loss of physiological reserve. Aside from the immediate challenges it presents, it is also associated with various adverse health outcomes. Given our ageing population, the healthcare and societal costs resulting from frailty present a significant and growing public health challenge. Rapidly accumulating evidence suggests that resistance exercise combined with protein supplementation can reverse frailty in older adults. However, translation of these findings into practice has proven difficult, due to either a lack of clarity regarding the interventions used or the use of interventions not suitable for widespread implementation. There remains an absence of evidence-based programmes suitable for delivery to frail older adults in the community.Methods and analysisThis paper outlines the protocol for a study to examine the effect of a novel programme of exercise and protein supplementation. This intervention has been developed by an expert consensus group, specifically for delivery to frail older adults in a group setting in the community. The study will take the form of a within-subjects non-randomised trial. Participants will be assessed at baseline, then following an 8-week period of regular activity, then following the 8-week intervention. Frailty (according to the Fried Frailty criteria) will be the primary outcome measure, along with a range of secondary outcome measures (including physical performance measures, body mass composition, psychosocial assessments and frailty-related biomarkers). If shown to be feasible to implement and effective at reversing frailty, the Diet and Exercise for FRAILty (DEFRAIL) intervention may facilitate more widespread participation in resistance exercise for frail older adults.Ethics and disseminationThis study received ethical approval from the Research Ethics committees of both the Health Service Executive South-Eastern Area and Waterford Institute of Technology. Its findings will be disseminated through journal publications, conference presentations and other forms of public engagement.Trial registration numberISRCTN46458028; Pre-results.

Dataset Information

Testing the feasibility of a primary-care exercise intervention to prevent and reverse early frailty and build resilience in community-dwelling older adults.

Background

Methods

Findings

Interpretation

Funding

Publications

Testing the feasibility of a primary-care exercise intervention to prevent and reverse early frailty and build resilience in community-dwelling older adults.

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