Clinical Trial

Effects of VIVIFRAIL Program on Functional Capacity and Geriatric Syndromes in the Elderly.

Study acronym: VIVIAL
Not Yet Recruiting
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Record status
This record was last updated February 27, 2026 (before its estimated June 15, 2026 completion). Its status may not reflect the trial's current state.
Summary
The aim of this quasi-experimental, pretest-posttest study is to evaluate the effectiveness of the Vivifrail multicomponent physical exercise program in improving the functional capacity of pre-frail and frail older adults (aged 70 and older) attending the Virgen del Mar Health Center in Almería. The main questions it aims to answer are: * Does functional capacity, as measured by the Short Physical Performance Battery (SPPB), significantly improve after participating in the Vivifrail program? * What is the effect of the Vivifrail program on various geriatric syndromes and associated health conditions (e.g., fall risk, sarcopenia, chronic pain, mild cognitive impairment, depression), and what patient profile is most likely to benefit from the intervention? * As a single-arm interventional study, there is no parallel comparison group. Researchers will compare each participant's outcomes against their own baseline at three time points (baseline, week 6, and week 12) to assess for significant improvements following the intervention. Participants will: * Complete a 12-week home-based, multicomponent physical exercise program (five sessions per week including strength, balance, flexibility, and aerobic endurance training), tailored to their baseline functional level. * Attend three in-person visits at the health center (baseline, a 6-week follow-up, and a final visit at 12 weeks) for the research staff to assess their clinical, functional, and sociodemographic variables. * Complete an Activity Diary to record their home-based sessions and perceived rate of exertion in order to monitor adherence. * Receive biweekly follow-up phone calls from the research team to reinforce motivation, track adherence, and monitor for any potential adverse events (e.g., falls, pain).
Trial Details
NCT Number NCT07436715
Lead Sponsor Elena Pérez Expósito, MD
Conditions Fragility
Enrollment 86 participants
Start Date 2026-03-16
Primary Completion 2026-06-15 (estimated)
Study Completion 2026-06-15 (estimated)
Updated on ClinicalTrials.gov 2026-02-27