Influence of a Multicomponent Supervised Exercise Program in Frail and Pre-Frail Community-Dwelling Older Adults: Study Protocol for a Randomized Controlled Trial.

Abstract

Frailty and pre-frailty are highly prevalent conditions among older adults and are associated with increased functional decline, fall risk, hospitalization, and mortality. Multicomponent supervised exercise programs have demonstrated efficacy in improving physical performance and mitigating frailty, particularly when adapted to older adults' functional capacity. However, evidence regarding Vivifrail-based interventions in frail and pre-frail older adults in Brazil remains limited. This study aims to evaluate the effects of a 12-week supervised multicomponent exercise program on functional capacity and fall risk among frail and pre-frail older adults. Additionally, the study intends to characterize participants according to frailty status, clinical-functional vulnerability, cognitive status, depressive symptoms, physical activity level, muscle mass, fear of falling, and sociodemographic and clinical characteristics at baseline. This study protocol describes a prospective, parallel-group, single-blind randomized controlled trial. Older adults aged 60 years and older regularly attending activities at the CONVIVER Community Center in Rio Verde, Goiás, Brazil, will be screened and randomized in a 1:1 ratio into either an intervention group or a control group. The intervention group will participate in a supervised multicomponent exercise program based on the Vivifrail model for 12 weeks, whereas the control group will participate in health education workshops focused on healthy aging. The primary outcomes will be functional capacity, assessed using the 6-Minute Walk Test, and fall risk/mobility performance, assessed using the Timed Up and Go Test. Baseline assessments will additionally include frailty status (Edmonton Frailty Scale), clinical-functional vulnerability (CFVI-20), cognitive status (Mini-Mental State Examination), depressive symptoms (Geriatric Depression Scale-15), physical activity level (International Physical Activity Questionnaire), calf circumference, fear of falling (Falls Efficacy Scale-International), and sociodemographic and clinical characteristics. Recruitment and baseline assessments are planned to occur between July and December 2026 at the CONVIVER Community Center. A total of 70 participants is expected to be enrolled and randomized into the intervention group (n=35) or the control group (n=35). At the time of manuscript submission, participant recruitment had not yet started, and no outcome data had been collected or analyzed. Final results are expected to be published in late 2027. This randomized controlled trial protocol describes a supervised multicomponent exercise intervention tailored to frail and pre-frail older adults in a Brazilian community setting. If effective, the intervention may represent a feasible, low-cost, and scalable strategy to improve functional capacity and reduce fall risk in vulnerable older populations while supporting evidence-based healthy aging initiatives. Brazilian Registry of Clinical Trials RBR-9zvtc5b; https://ensaiosclinicos.gov.br/rg/RBR-9zvtc5b.