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Not Yet Recruiting NCT07732478

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.

Conditions: Frailty/Sarcopenia, Frailty in Older Adults, Sarcopenia

Sex: All
Ages: 65 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 300
Sponsor: Universidad de Granada

Location: Faculty of Sports Science Granada Andalusia

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 Criteria

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07732478). StuddyBuddy aggregates publicly available trial information.