- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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).
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: JAVIER Fernández-Ortega, PhD Student, Sports Science
- Numéro de téléphone: +34 958246635
- E-mail: fernandezortegaj@ugr.es
Sauvegarde des contacts de l'étude
- Nom: Andrés B. Fernández-Revelles, Sport Sciences
- E-mail: abfr@ugr.es
Lieux d'étude
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Andalusia
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Granada, Andalusia, Espagne, 18004
- Faculty of Sports Science
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Contact:
- Andrés B. Fernández-Revelles, Principal Investigator, Sport Science
- Numéro de téléphone: +34 958246635
- E-mail: abfr@ugr.es
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte plus âgé
Accepte les volontaires sains
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Short Physical Performance Battery (SPPB) score
Délai: Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
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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.
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Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Handgrip strength
Délai: Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
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Isometric strength of the upper limb measured using a Jamar-type hand dynamometer, expressed in kilograms.
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Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
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30-Second Chair Stand Test
Délai: Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
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Number of full stands completed from a seated position in 30 seconds, used as a measure of lower-limb muscular strength and endurance.
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Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
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6-Minute Walk Test (6MWT) distance
Délai: Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
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Total distance (in meters) walked in 6 minutes, used as a measure of cardiorespiratory capacity and functional exercise tolerance.
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Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
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Body weight and Body Mass Index (BMI)
Délai: Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
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Body weight (kg) and BMI, calculated from measured weight and height, assessed as basic anthropometric indicators.
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Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
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Waist circumference
Délai: Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
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Waist circumference (cm), used as an indicator of central adiposity.
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Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
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Self-perceived fitness (International Fitness Scale, IFIS)
Délai: Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
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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.
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Baseline (week 0) and post-intervention (week 36), for each of the four annual cohorts (2026-2030)
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Andrés B. Fernández-Revelles, Sport Science, Universidad de Granada
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- #6186
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- ANALYTIC_CODE
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