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.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversidad de Granada

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Terminal illness

Residing in a nursing home

Diagnosed with, or under investigation for, moderate to severe cognitive impairment

Unstable cardiovascular disease

Trial design

Design model

Single group

Treatments tested in this trial

  • Multicomponent Exercise Program (Vivifrail-based)

    Behavioral

    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.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Community Multicomponent Exercise ProgramExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Short Physical Performance Battery (SPPB) score

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.

Time frame
Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)

Secondary outcomes

1

Handgrip strength

Isometric strength of the upper limb measured using a Jamar-type hand dynamometer, expressed in kilograms.

Time frame
Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
2

30-Second Chair Stand Test

Number of full stands completed from a seated position in 30 seconds, used as a measure of lower-limb muscular strength and endurance.

Time frame
Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
3

6-Minute Walk Test (6MWT) distance

Total distance (in meters) walked in 6 minutes, used as a measure of cardiorespiratory capacity and functional exercise tolerance.

Time frame
Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
4

Body weight and Body Mass Index (BMI)

Body weight (kg) and BMI, calculated from measured weight and height, assessed as basic anthropometric indicators.

Time frame
Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: