Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07436715
NA

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

Sponsor: Elena Pérez Expósito, MD

View on ClinicalTrials.gov

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).

Official title: Effects of the VIVIFRAIL Multicomponent Physical Exercise Program on Functional Capacity and Geriatric Syndromes in Frail and Pre-frail Older Adults Over 70 Years in Primary Care in Almeria: A Quasi-Experimental Study.

Key Details

Gender

All

Age Range

70 Years - Any

Study Type

INTERVENTIONAL

Enrollment

86

Start Date

2026-03-16

Completion Date

2026-06-15

Last Updated

2026-02-27

Healthy Volunteers

No

Conditions

Interventions

OTHER

Behavioral: Vivifrail multicomponent physical exercise program

The Vivifrail multicomponent physical exercise program is a structured, 12-week home-based regimen. The standardized protocol requires 5 sessions per week: 3 non-consecutive days of 45-60 minute multicomponent training (focusing on upper and lower body strength using household items like water bottles or elastic bands, static/dynamic balance, and flexibility) and 2 days of 20-40 minute aerobic endurance training (brisk walking). Exercise intensity is prescribed at a moderate rate of perceived exertion (Borg scale 4-6). A systematic progression in exercise load and duration is implemented starting at week 7, strictly adhering to the guidelines of the participant's assigned passport.

Locations (1)

Primary Care Center Virgen del Mar (Centro de Salud Virgen del Mar)

Almería, ALMERÍA, Spain