Effects of VIVIFRAIL Program on Functional Capacity and Geriatric Syndromes in the Elderly.
Starting soon · Not applicable
Conditions studied: Fragility
In brief
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).
Key facts
- Study ID
- NCT07436715
- Run by
- Elena Pérez Expósito, MD
- People needed
- 86
- Starts
- 2026-03-16
- Expected to finish
- 2026-06-15
- Last updated by the study team
- 2026-02-27
Who can join
Age: 70 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants aged 70 years or older.
- Classified as pre-frail or frail according to the FRAIL scale (score ≥ 1).
- Barthel Index score ≥ 60 points.
- Ability to communicate effectively.
- Ability to ambulate, with or without assistive devices.
You may not qualify if…
- Recent acute myocardial infarction or unstable angina.
- Uncontrolled atrial or ventricular arrhythmias.
- Dissecting aortic aneurysm.
- Severe aortic stenosis.
- Acute endocarditis or pericarditis.
- Uncontrolled arterial hypertension.
- Acute thromboembolic disease.
- Severe acute heart failure.
- Severe acute respiratory failure.
- Uncontrolled orthostatic hypotension.
- Diabetes mellitus with acute decompensation or uncontrolled hypoglycemia.
- Recent bone fracture within the last month.
- Institutionalization (e.g., nursing home residents).
Where it is running
- Primary Care Center Virgen del Mar (Centro de Salud Virgen del Mar) — Almería, ALMERÍA, Spain
Full record on ClinicalTrials.gov
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