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.
1 other identifier
interventional
300
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2026
CompletedFirst Posted
Study publicly available on registry
July 29, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2030
Study Completion
Last participant's last visit for all outcomes
July 31, 2030
July 30, 2026
July 1, 2026
3.7 years
July 23, 2026
July 28, 2026
Conditions
Keywords
Outcome Measures
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.
Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
Secondary Outcomes (6)
Handgrip strength
Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
30-Second Chair Stand Test
Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
6-Minute Walk Test (6MWT) distance
Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
Body weight and Body Mass Index (BMI)
Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
Waist circumference
Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
- +1 more secondary outcomes
Study Arms (1)
Community Multicomponent Exercise Program
EXPERIMENTALParticipants aged 65 and older meeting the inclusion criteria take part in the pre-existing 36-week multicomponent exercise program delivered by the Santoña Town Council. Functional and physical assessments are performed at baseline (week 0) and at the end of each 36-week cycle (week 36), across four consecutive academic years. Each participant serves as their own control.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Sports Science
Granada, Andalusia, 18004, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrés B. Fernández-Revelles, Sport Science
Universidad de Granada
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Andrés B. Fernández-Revelles, Principal Investigator, Associate Professor; Javier Fernández-Ortega, PhD Student
Study Record Dates
First Submitted
July 23, 2026
First Posted
July 29, 2026
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
June 1, 2030
Study Completion (Estimated)
July 31, 2030
Last Updated
July 30, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Beginning after publication of the main results article associated with each cohort, with no specified end date.
- Access Criteria
- Data will be made available to researchers who provide a methodologically sound proposal, upon reasonable request to the corresponding author. Requests should specify the intended use of the data and will be reviewed by the research team.
De-identified individual participant data collected during the study (anthropometric, functional, and cardiorespiratory outcome measures) will be made available, along with an accompanying data dictionary describing all variables collected.