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

Carl-Philipp Jansen, Corinna Nerz, Franziska Kramer, Sarah Labudek, Jochen Klenk, Judith Dams, Hans-Helmut König, Lindy Clemson, Clemens Becker, Michael Schwenk, Carl-Philipp Jansen, Corinna Nerz, Franziska Kramer, Sarah Labudek, Jochen Klenk, Judith Dams, Hans-Helmut König, Lindy Clemson, Clemens Becker, Michael Schwenk

Abstract

Background: 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. 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.

Methods: 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, 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.

Discussion: Compared 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 registration: ClinicalTrials.gov NCT03462654 . Registered on March 12, 2018.

Keywords: Balance; Fall prevention; Functional exercise; Health behaviour intervention; Physical activity; Randomized noninferiority trial; Strength.

Conflict of interest statement

Ethics approval and consent to participate

Ethical approval for the project was obtained from the Ethic Review Board of the Faculty of Behavioral and Cultural Studies at Heidelberg University (for the study site Heidelberg; document number Schwe2017 2/1–1), and from the Ethic Review Board of the University Hospital and Faculty of Medicine in Tübingen (for the study site Stuttgart; document number 723/2017BO2). Amendments to protocol are to be approved by the Ethic Review Boards before coming into effect. The study is conforming to the respective policy and mandates of the Declaration of Helsinki. Participants’ written informed consent is obtained from assessors at their first screening visit at the study site.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
SPIRIT participant flow chart; †in Stuttgart, a health insurance company additionally contacted their members who matched the inclusion criteria

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