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

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

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JANSEN, Carl-Philipp, Corinna NERZ, Franziska KRAMER, Sarah LABUDEK, Jochen KLENK, Hans-Helmut KÖNIG, Lindy CLEMSON, Judith DAMS, Clemens BECKER, Michael SCHWENK, 2018. Comparison of a group-delivered and individually delivered lifestyle-integrated functional exercise (LiFE) program in older persons : a randomized noninferiority trial. In: BMC geriatrics. BioMed Central. 18(1), 267. eISSN 1471-2318. Available under: doi: 10.1186/s12877-018-0953-6

@article{Jansen2018Compa-55326, title={Comparison of a group-delivered and individually delivered lifestyle-integrated functional exercise (LiFE) program in older persons : a randomized noninferiority trial}, year={2018}, doi={10.1186/s12877-018-0953-6}, number={1}, volume={18}, journal={BMC geriatrics}, author={Jansen, Carl-Philipp and Nerz, Corinna and Kramer, Franziska and Labudek, Sarah and Klenk, Jochen and König, Hans-Helmut and Clemson, Lindy and Dams, Judith and Becker, Clemens and Schwenk, Michael}, note={Article Number: 267} }

Jansen, Carl-Philipp Becker, Clemens Dams, Judith Comparison of a group-delivered and individually delivered lifestyle-integrated functional exercise (LiFE) program in older persons : a randomized noninferiority trial Clemson, Lindy Schwenk, Michael Dams, Judith Schwenk, Michael Background:<br />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.<br /><br />Methods:<br />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.<br /><br />Discussion:<br />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.<br /><br />Trial registration:<br />ClinicalTrials.gov NCT03462654. Registered on March 12, 2018. 2021-10-25T07:49:56Z König, Hans-Helmut 2018 Klenk, Jochen 2021-10-25T07:49:56Z Clemson, Lindy Becker, Clemens Jansen, Carl-Philipp Kramer, Franziska eng Nerz, Corinna Labudek, Sarah König, Hans-Helmut Nerz, Corinna Klenk, Jochen Kramer, Franziska Attribution 4.0 International Labudek, Sarah

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