Effects of a Community-based Multicomponent Physical Exercise Program on Physical Function, Frail… (NCT07732478) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effects of a Community-based Multicomponent Physical Exercise Program on Physical Function, Frailty, and Sarcopenia in Older Adults From the Municipality of Santoña: a Quasi-experimental Study.
Spain300 participantsStarted 2026-10-01
Plain-language summary
This study evaluates the effects of a community-based multicomponent exercise program on physical function, frailty, and sarcopenia in older adults living in the municipality of Santoña (Cantabria, Spain). The exercise program is organized and delivered by the Santoña Town Council as part of its public health services for older residents and is not created for research purposes; it will continue regardless of the outcome of this study. Researchers are only evaluating participants who voluntarily agree to be assessed before and after each 36-week cycle of the program, over four consecutive academic years (2026-2030). The main question this study aims to answer is whether continued participation in this real-world, community-based multicomponent exercise program (based on the Vivifrail model) leads to meaningful improvements in physical function, muscle strength, and cardiorespiratory capacity, and helps reverse indicators of frailty and sarcopenia in independent, community-dwelling older adults. Participants will complete functional and physical tests, including balance, gait speed, chair-stand performance, handgrip strength, and a 6-minute walk test, at the start and end of each 36-week exercise cycle. No blood or biological samples will be collected.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 65 years or older
* Independent, community-dwelling (not institutionalized)
* Barthel Index score ≥ 90 points (no significant disability)
* Timed Up and Go (TUG) test ≥ 10 seconds
* Short Physical Performance Battery (SPPB) score below 12 points (indicating possible frailty)
* Fall risk indicated by at least one of the following: one fall in the past year requiring assistance, more than one fall without assistance, TUG \> 20 seconds, or gait speed over 6 meters \> 7.50 seconds
* Reduced grip strength: below 27 kg (men) or below 16 kg (women), or more than 15 seconds to complete 5 chair stands
* Voluntary signed informed consent
Exclusion Criteria:
* Terminal illness
* Residing in a nursing home
* Diagnosed with, or under investigation for, moderate to severe cognitive impairment
* Unstable cardiovascular disease
* Acute infectious disease
* Uncontrolled hypertension (systolic \> 180 mmHg or diastolic \> 110 mmHg)
* Uncontrolled diabetes
* Advanced organ failure
* Disabling musculoskeletal condition
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Short Physical Performance Battery (SPPB) score
Timeframe: Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
Trial details
NCT IDNCT07732478
SponsorUniversidad de Granada
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2030-06-01
Contact for this trial
JAVIER Fernández-Ortega, PhD Student, Sports Science