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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sarcopenia; Frailty/Sarcopenia; Frailty in Older Adults
• Intervention / Treatment: Behavioral: Multicomponent Exercise Program (Vivifrail-based)

Detailed Description

Most of the existing evidence on the benefits of multicomponent exercise for reversing frailty and sarcopenia in older adults comes from lab-based clinical trials conducted in highly controlled hospital or laboratory settings. While these studies have strong internal validity, they often lack ecological validity, meaning they do not reflect the real-world conditions, barriers, and adherence dynamics of community-based programs. There is therefore a public health need to evaluate whether the efficacy demonstrated in controlled settings translates into real, sustainable effectiveness when delivered through existing municipal, real-world programs.

This study evaluates a pre-existing, independently run community exercise program organized by the Santoña Town Council (Cantabria, Spain) for older adults referred through local health centers. The program has been running for several years and will continue to be delivered by the Town Council regardless of this study's outcome. The scope of this research is limited to the scientific evaluation of participants' physical and functional status before and after their participation in the program; the research team has no role in designing, modifying, or delivering the exercise intervention itself.

Design: This is a quasi-experimental, single-group, repeated-measures (pre-post) study. A passive control group was not included, as the community health-promotion nature of the program makes it inappropriate to withhold access to exercise and its benefits from eligible older residents. Each participant serves as their own control, comparing baseline and post-intervention measures.

Intervention being evaluated: The municipal exercise program follows a 36-week multicomponent format addressing strength, balance, endurance, and flexibility, structured according to the FITT-VP principles of the Vivifrail model (Izquierdo, 2019). Sessions are supervised by qualified exercise professionals who individualize training loads. The research team is not modifying this program in any way; researchers are solely adding an assessment protocol before and after each 36-week cycle.

Recruitment and timeframe: Recruitment will take place annually over four consecutive academic years (2026/2027 to 2029/2030), with an estimated 60 participants recruited per cohort, for a cumulative total of approximately 240 participants across the study period.

Outcome assessment: At baseline (week 0) and at the end of each 36-week cycle (week 36), participants will undergo: basic anthropometric measurements (weight, height, waist circumference); a self-perceived fitness questionnaire (IFIS); the Short Physical Performance Battery (SPPB), assessing balance, 4-meter gait speed, and 5-times chair-stand performance; handgrip strength via isometric dynamometry; the 30-Second Chair Stand Test as an additional measure of lower-limb strength; and the 6-Minute Walk Test to assess cardiorespiratory capacity. No blood draws, biopsies, or other biological samples are collected at any point.

Safety considerations: Because participants are community-dwelling older adults rather than clinical patients, the assessment protocol does not interfere with any necessary medical treatment, and no placebo is used. Expected adverse effects are mild and transient (e.g., delayed-onset muscle soreness, general fatigue, occasional mild joint discomfort), with a low inherent risk of musculoskeletal injury or falls associated with physical exertion. All sessions are supervised by qualified exercise professionals, loads are individualized, and an adverse event monitoring and reporting protocol is in place. Participants are covered by the Santoña Town Council's civil liability insurance for municipal activities and facilities.

Setting: Data collection and the exercise program take place at municipal sports facilities and community centers made available by the Santoña Town Council under an institutional collaboration agreement. Scientific direction, statistical analysis, and custody of anonymized data are centrally managed by the research team at the University of Granada (UGR).

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: JAVIER Fernández-Ortega, PhD Student, Sports Science; Phone Number: +34 958246635; Email: fernandezortegaj@ugr.es
• Study Contact Backup: Name: Andrés B. Fernández-Revelles, Sport Sciences; Email: abfr@ugr.es

Study Locations

• Spain
  • Andalusia
    • Granada, Andalusia, Spain, 18004
      • Faculty of Sports Science
      • Contact: Andrés B. Fernández-Revelles, Principal Investigator, Sport Science; Phone Number: +34 958246635; Email: abfr@ugr.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Community Multicomponent Exercise Program; Participants 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.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Handgrip strength	Isometric strength of the upper limb measured using a Jamar-type hand dynamometer, expressed in kilograms.	Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
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.	Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
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.	Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
Body weight and Body Mass Index (BMI)	Body weight (kg) and BMI, calculated from measured weight and height, assessed as basic anthropometric indicators.	Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
Waist circumference	Waist circumference (cm), used as an indicator of central adiposity.	Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
Self-perceived fitness (International Fitness Scale, IFIS)	Self-reported perception of overall physical fitness and its four specific dimensions (cardiorespiratory fitness, muscular strength, speed-agility, and flexibility) assessed using the International Fitness Scale (IFIS). The scale consists of 5 main items, each evaluated on a 5-point Likert scale ranging from 1 ("very poor") to 5 ("very good"). Each individual item score ranges from 1 to 5, where higher scores indicate better self-perceived physical fitness.	Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Investigators: Principal Investigator: Andrés B. Fernández-Revelles, Sport Science, Universidad de Granada

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): July 31, 2030

Study Registration Dates

• First Submitted: July 23, 2026
• First Submitted That Met QC Criteria: July 23, 2026
• First Posted (Actual): July 29, 2026

Study Record Updates

• Last Update Posted (Actual): July 30, 2026
• Last Update Submitted That Met QC Criteria: July 28, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Sarcopenia; Older adults; Muscle strength; Fall prevention; Physical function; Cardiorespiratory fitness; Community-based exercise program; Multicomponent exercise; Frailty prevention; Real-world effectiveness
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathologic Processes; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Frailty; Sarcopenia
• Other Study ID Numbers: #6186

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning after publication of the main results article associated with each cohort, with no specified end date.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No