Abstract
BackgroundThe Lifestyle-Integrated Functional Exercise (LiFE) program is effective in improving strength, balance, and physical activity (PA) while simultaneously reducing falls in older people by incorporating exercise activities in recurring daily tasks. However, implementing the original LiFE program includes substantial resource requirements. Therefore, as part of the LiFE-is-LiFE project, a group format (gLiFE) of the LiFE program has been developed, which will be tested regarding its noninferiority to the individually delivered LiFE in terms of PA-adjusted fall incidence and overall cost-effectiveness.MethodsIn a multi-centre, single-blinded noninferiority trial, an envisaged sample of N = 300 participants (> 70 years; faller and/or confirmed falls risk; community-dwelling) will be randomized in either LiFE or gLiFE. Both groups will undergo the same strength and balance activities as well as PA promotion activities and habitualization strategies as described in the LiFE programme, however, based on different approaches of delivery: During the 6-month intervention phase, LiFE participants will receive seven home visits and two telephone calls; in gLiFE, the program will be delivered in seven group sessions and also two telephone calls. Main outcomes are a) fall incidence per PA and b) incremental cost-effectiveness ratio comparing costs and quality-adjusted life years between the two interventions. Secondary outcomes include PA behaviour, motor performance, health status, psychosocial status, program evaluation, and adherence. Measurements will be conducted at baseline, 6-month and 12-month follow-up; evaluation of intervention sessions and assessment of psychosocial variables related to execution and habitualization of LiFE activities will be made during the intervention period as well.DiscussionCompared to LiFE, we expect gLiFE to (a) reduce falls per PA by a similar rate; (b) be more cost-effective; (c) comparably enhance physical performance in terms of strength and balance as well as PA. By investigating the economic and societal benefit, this study will be of high practical relevance as noninferiority of gLiFE would facilitate large-scale implementation due to lower resource usage. This would result in better reach and increased accessibility, which is important for subjects with a history of falls and/or being at risk of falls.Trial registrationClinicalTrials.gov NCT03462654. Registered on March 12, 2018.
Highlights
The Lifestyle-Integrated Functional Exercise (LiFE) program is effective in improving strength, balance, and physical activity (PA) while simultaneously reducing falls in older people by incorporating exercise activities in recurring daily tasks
The adapted approach delivered in the trial at hand was tested in a small pilot study. In this current LiFEis-LiFE project, Group LiFE (gLiFE) is going to be tested for its noninferiority compared to LiFE in terms of fall incidence and cost-effectiveness. We hypothesize in this multi-centre, two armed, singleblinded, randomised noninferiority trial that: (1) gLiFE won’t be less efficacious than LiFE in terms of reducing fall incidence expressed as number of falls per PA, i.e., energy expenditure; gLiFE won’t result in a lower intervention retention rate as compared to LiFE; (2) delivering gLiFE will be cost-effective and less costly compared with LiFE; (3) in both groups, physical performance in terms of strength and balance as well as physical activity will be enhanced at comparable levels
To assess adherence to i/gLiFE, participants fill out the Exercise Adherence Rating Activities-specific balance confidence scale (Scale) (EARS; [63]) on a monthly basis
Summary
In a multi-centre, single-blinded noninferiority trial, an envisaged sample of N = 300 participants (> 70 years; faller and/or confirmed falls risk; community-dwelling) will be randomized in either LiFE or gLiFE. Both groups will undergo the same strength and balance activities as well as PA promotion activities and habitualization strategies as described in the LiFE programme, based on different approaches of delivery: During the 6-month intervention phase, LiFE participants will receive seven home visits and two telephone calls; in gLiFE, the program will be delivered in seven group sessions and two telephone calls. Measurements will be conducted at baseline, 6-month and 12-month followup; evaluation of intervention sessions and assessment of psychosocial variables related to execution and habitualization of LiFE activities will be made during the intervention period as well
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