Comparison of a group-delivered and individually delivered lifestyle-integrated functional exercise (LiFE) program in older persons: a randomized noninferiority trial

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.

Development of a conceptual framework for a group-based format of the Lifestyle-integrated Functional Exercise (gLiFE) programme and its initial feasibility testing

“…01GL1705A-D) comparing gLiFE to LiFE is currently being carried out and not described in this paper. The study protocol is described elsewhere [17].…”

“…LiFE resulted in a greater increase in motor performance, physical activity and a greater decrease in fall rate compared to the comparator groups. Despite its high potential, LiFE's large-scale implementability is hampered by its resource-intensive one-to-one delivery format within seven home visits [17][18][19]. A promising solution could be delivering LiFE in a group format (gLiFE).…”

Group or Individual Lifestyle-Integrated Functional Exercise (LiFE)? A Qualitative Analysis of Acceptability

“…Hence, gLiFE and LiFE could be appropriate for implementation within public health initiatives. Whether gLiFE has non-inferior or superior effectiveness as compared to LiFE is currently examined (19). Figure 1 Recruitment process…”

“…This qualitative study was conducted as part of the LiFE-is-LiFE trial (19), a 12-month multi-center, singleblinded, randomized non-inferiority trial comparing gLiFE with LiFE regarding fall reduction and costeffectiveness (ClinicalTrials.gov, NCT03462654) (period: 06/2018 to 08/2020). Participants with a veri ed fall risk took part in either seven gLiFE or LiFE sessions within eleven weeks, followed by two phone calls.…”

“…Table 1 provides an overview of similarities and differences of both formats. Table 1 Similarities and differences between LiFE and gLiFE conducted in the LiFE-is-LiFE trial (19) Trainers teach the participants how to perform the activities (e.g., squat), where (e.g., in the bedroom), and when to implement these into daily routines (e.g., each time when reaching for the oor drawer). New movement habits are created by linking the LiFE activities to speci c daily situations based on behavior change concepts (9,21).…”