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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.

28 juli 2026 bijgewerkt door: JAVIER FERNÁNDEZ-ORTEGA, Universidad de Granada
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.

Studie Overzicht

Gedetailleerde beschrijving

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).

Studietype

Ingrijpend

Inschrijving (Geschat)

300

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: JAVIER Fernández-Ortega, PhD Student, Sports Science
  • Telefoonnummer: +34 958246635
  • E-mail: fernandezortegaj@ugr.es

Studie Contact Back-up

  • Naam: Andrés B. Fernández-Revelles, Sport Sciences
  • E-mail: abfr@ugr.es

Studie Locaties

    • Andalusia
      • Granada, Andalusia, Spanje, 18004
        • Faculty of Sports Science
        • Contact:
          • Andrés B. Fernández-Revelles, Principal Investigator, Sport Science
          • Telefoonnummer: +34 958246635
          • E-mail: abfr@ugr.es

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Short Physical Performance Battery (SPPB) score
Tijdsspanne: 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.
Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Handgrip strength
Tijdsspanne: Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
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
Tijdsspanne: Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
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
Tijdsspanne: Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
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)
Tijdsspanne: Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
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
Tijdsspanne: Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
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)
Tijdsspanne: Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Andrés B. Fernández-Revelles, Sport Science, Universidad de Granada

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 juni 2030

Studie voltooiing (Geschat)

31 juli 2030

Studieregistratiedata

Eerst ingediend

23 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

23 juli 2026

Eerst geplaatst (Werkelijk)

29 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

28 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

Beginning after publication of the main results article associated with each cohort, with no specified end date.

IPD-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ANALYTIC_CODE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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