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

NCT07436715 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-02-27

No results posted yet for this study

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).

Conditions

  • Fragility

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.

Sponsors & Collaborators

  • Elena Pérez Expósito, MD

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-16
Primary Completion
2026-06-15
Completion
2026-06-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07436715 on ClinicalTrials.gov