- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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).
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: JAVIER Fernández-Ortega, PhD Student, Sports Science
- Número de teléfono: +34 958246635
- Correo electrónico: fernandezortegaj@ugr.es
Copia de seguridad de contactos de estudio
- Nombre: Andrés B. Fernández-Revelles, Sport Sciences
- Correo electrónico: abfr@ugr.es
Ubicaciones de estudio
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Andalusia
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Granada, Andalusia, España, 18004
- Faculty of Sports Science
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Contacto:
- Andrés B. Fernández-Revelles, Principal Investigator, Sport Science
- Número de teléfono: +34 958246635
- Correo electrónico: abfr@ugr.es
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Short Physical Performance Battery (SPPB) score
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Handgrip strength
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Andrés B. Fernández-Revelles, Sport Science, Universidad de Granada
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- #6186
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
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