Ireland
--:--IST
Starting soon Not 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.

NCT07732478 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2026-10-01
Last updated
2026-07-30

Condition(s) studied

Frailty/SarcopeniaFrailty in Older AdultsSarcopenia

Investigational drug(s) / intervention(s)

Multicomponent Exercise Program (Vivifrail-based)

Multicomponent Exercise Program (Vivifrail-based): A 36-week community-based multicomponent exercise program addressing strength, balance, endurance, and flexibility, structured according to the Vivifrail FITT-VP model. Sessions are delivered by qualified exercise professionals as part of the Santoña Town Council's existing public health services, independently of this study.

Study 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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Short Physical Performance Battery (SPPB) score — Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
    Composite score assessing lower-extremity physical function through three components - standing balance, 4-meter gait speed, and time to complete five repeated chair stands. Total score ranges from 0 to 12, with lower scores indicating greater physical frailty.

Trial sites (1)

FacilityCityRegionStatus
Faculty of Sports Science Granada Andalusia
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07732478 on ClinicalTrials.gov ↗ ← All trials in Spain