Effectiveness and cost-effectiveness of a home-based functional exercise programme for community-dwelling frail older adults, ACTIVE-AGE@home, provided by professionals and volunteers: protocol of a pragmatic randomised controlled trial.

Between 2020 and 2050, the world's population aged 80 years and over will triple, drastically increasing the prevalence of frailty and associated healthcare costs. Multimodal exercise programmes have proven to be an ideal countermeasure for frailty, but the current Flemish standard of care does not include them. The purpose of this study is to investigate the effect of the home-based exercise programme for frail community-dwelling older adults (>70 years), ACTIVE-AGE@home, on frailty-associated outcomes, when delivered by professionals or volunteers, as well as its cost-effectiveness. A pragmatic randomised controlled trial will be conducted. Participants will be randomised into three parallel groups using permuted block randomisation. There will be two intervention groups: in one group, the intervention is delivered by professionals with a bachelor or masters' degree in physiotherapy, occupational therapy and/or physical education, and in the other by trained volunteers. Both groups will be compared with a control group receiving usual care. Participants (n=195) are community-dwelling frail older adults (>70 years), as defined by Fried et al. (2001). The intervention is a 24 week programme that consists of three 1 hour visits per week and contains aerobic, strength, balance, flexibility, coordination and dual tasking exercises, accompanied by goal-setting and motivational interviewing. The Timed Chair Stand (TCS) test is the primary outcome. Functional ability, cognition, loneliness, self-management, health-related quality of life, healthcare utilisation and meaningful activities will be measured in all groups at 0, 24 and 48 weeks. Time and expenses invested by professionals or volunteers will be kept in diaries for trial and model-based cost-effectiveness analyses, expressed in incremental cost per QALY (quality-adjusted life year). The model will be designed to associate the frailty at the end of follow-up with further expected healthcare expenses beyond the duration of the trial. Statistical analysis will be blinded to group allocation, and outcome assessors will be blinded to the maximal extent possible. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the Medical Ethics Committee of UZ Brussel (O.G. 016), Peer reflection group Biomedical Ethics, Laarbeeklaan 101, 1090 Brussels. Results will be disseminated in publications and other relevant platforms. This study was registered at Clinicaltrials.gov on 6 July 2023 and posted on 14 July 2023 after National Library of Medicine quality control review. Registration details: NCT05946109 TRIAL REGISTRATION NUMBER: NCT05946109.