Multicomponent exercise (ViviFrail®) for cognition and depressive symptoms in older adults: a protocol for a randomized controlled trial in socially vulnerable populations

Background: As global populations age, evidence-based exercise programs are increasingly important for promoting healthy aging. However, data on their effectiveness among socially vulnerable older adults in Latin America remain limited. Objectives: This study presents the protocol for a single-blind randomized controlled trial evaluating the effects of a multicomponent exercise program (MCEP), based on the ViviFrail® model, on depressive symptoms and cognitive function in this population. Methods: A total of 134 community-dwelling adults aged ≥ 60 years will be randomly assigned (1:1) to either an intervention group (IG) or a control group (CG). The IG will complete a 24-week home-based MCEP incorporating resistance, aerobic, balance, and flexibility training. The CG will participate in 12 weeks of structured social activities, after which they will be offered the ViviFrail® program for ethical and engagement purposes. However, these delayed-intervention data will not be included in the primary analysis. Assessments will be conducted at baseline and weeks 7, 14, 21, and 28, with week 28 representing the post-intervention time point for the IG. The primary outcome will be change in depressive symptoms, measured by the 15-item Geriatric Depression Scale. Secondary outcomes will include cognitive function (Mini-Mental State Examination), quality of life (EuroQol 5-Dimension questionnaire), functional ability (Lawton instrumental activities of daily living scale), and mobility/fall risk (Timed Up and Go test). Data will be analyzed using general linear models for repeated measures, with both intention-to-treat and per-protocol approaches. The trial has received ethical approval (CAEE approval blinded for review) and is registered with the Brazilian Clinical Trials Registry (ReBEC). Expected results: Participants allocated to the IG will show greater reductions in depressive symptoms and improvements in cognitive function, quality of life, functional ability, and mobility compared with the control group. Relevance: Findings may provide robust evidence on the feasibility and benefits of structured exercise to improve mental and cognitive health in underserved older adults.