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

BACKGROUND Multicomponent supervised exercise programs have demonstrated efficacy in improving physical performance and mitigating frailty in older adults, especially when adapted to functional capacity. However, evidence remains limited regarding their effects in community-dwelling frail and pre-frail individuals in Brazil. OBJECTIVE This protocol study aimed to evaluate the effects of a 12-week multicomponent supervised exercise program on frailty status, functional capacity, clinical-functional vulnerability, and fall risk in frail and pre-frail community-dwelling older people. METHODS This protocol describes the methodology of a single-blind, randomized controlled trial, which will assess a total of 60 participants aged 60 years and older that will be recruited from a community senior center in Rio Verde, Brazil, and randomly allocated to an intervention group (multicomponent supervised exercise based on the VIVIFRAIL model) or to a control group (educational workshops on healthy aging). The primary outcomes will be functional capacity (6-Minute Walk Test) and fall risk (Timed Up and Go Test), but covariates will include clinical-functional vulnerability (CFVI-20), cognitive status (MMSE), depressive symptoms (GDS-15), physical activity level (IPAQ), muscular mass (calf circumference), and fear of falling (FES-I). Assessments will be conducted at baseline and post-intervention. RESULTS This protocol will provide evidence regarding the effectiveness of a supervised multicomponent exercise program for improving frailty status, functional outcomes, and fall-related risk in a vulnerable population of Brazilian elderly. CONCLUSIONS If effective, the intervention may offer a scalable, low-cost, and culturally appropriate strategy to promote healthy aging and reduce physical decline in community settings vulnerable subgroups. CLINICALTRIAL Brazilian Registry of Clinical Trials RBR-9zvtc5b; https://ensaiosclinicos.gov.br/rg/RBR-9zvtc5b