- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07680036
RESISTANCE TRAINING AND CAPILLARIZATION - ROLE ON THE ANABOLIC RESPONSE IN OLDER ADULTS (RECAP)
The goal of this clinical trial is to learn how muscle capillaries influence the response to resistance exercise training in older adults. The study will include older men and women who may experience age-related declines in muscle mass and function. The main questions it aims to answer are:
- Does baseline muscle capillarization influence the increase in muscle size and function following resistance exercise training?
- Can resistance exercise stimulate the formation of new capillaries in older adults with lower baseline capillarization, and how is this related to muscle growth?
Participants will:
- Undergo assessments of muscle structure, capillarization, and physical function before and after the intervention.
- Participate in a supervised resistance exercise training program.
- Provide muscle samples and other physiological measurements to evaluate changes in muscle growth and blood vessel formation.
Researchers will analyze the relationship between baseline muscle capillarization, exercise-induced angiogenesis, and improvements in muscle mass and function to better understand why some older adults respond more effectively to resistance exercise than others.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This randomized clinical trial will investigate the effects of different exercise training strategies on skeletal muscle adaptations in older adults. Participants will be randomly assigned to one of three training groups and will complete a supervised 12-week exercise program, consisting of three sessions per week.
The interventions will include different combinations and sequencing of resistance and aerobic exercise during the first 8 weeks of training, followed by a standardized resistance training program during the final 4 weeks. The study is designed to determine whether the timing and type of exercise influence muscle growth, vascular adaptations, and functional outcomes.
Participants will undergo assessments before the intervention and after 4, 8, and 12 weeks of training. Measurements will include body composition, muscle size and architecture, muscle strength, aerobic fitness, and physical function. A subgroup of participants may also undergo optional muscle biopsies to evaluate changes in muscle capillarization and biological markers associated with muscle adaptation.
The results will help identify exercise strategies that optimize muscle and vascular adaptations in older adults and improve understanding of the mechanisms underlying individual variability in training responsiveness.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
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PD
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Padova, PD, Italia, 35131
- Nutrition and Exercise Lab, DSB
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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
- Body Mass Index (BMI) >18 and <30 kg/m²
- Stable body weight for at least 3 months prior to enrollment
Exclusion Criteria:
- Prediabetes or diabetes according to ADA criteria
- Chronic diseases, including cardiovascular, liver, respiratory diseases, or cancer
- Acute inflammatory conditions, infections, or other clinically significant illnesses
- Regular participation in vigorous physical activity (≥2 sessions per week)
- Current or recent (within the previous 3 months) treatment with steroid medications
- Regular use of protein supplements
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: RRR
Effect of 3 months of progressive resistance training on muscle adaptation in older adults
|
2 months of different combination of aerobic and resistance training before undergoing to 1 month of resistance training at 80% 1RM
|
|
Comparador activo: ARR
Effect of 1 month of aerobic training followed by 2 months of progressive resistance training on muscle adaptation in older adults
|
2 months of different combination of aerobic and resistance training before undergoing to 1 month of resistance training at 80% 1RM
|
|
Comparador activo: RAR
Effect of the combination of 1 month of resistance training followed by 1 month of aerobic training and 1 months of progressive resistance training on muscle adaptation in older adults
|
2 months of different combination of aerobic and resistance training before undergoing to 1 month of resistance training at 80% 1RM
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
muscle hypertrophy
Periodo de tiempo: 3 months
|
difference of kilograms of Lean Body Mass from baseline measured by DEXA
|
3 months
|
|
capillary density
Periodo de tiempo: 3 month
|
change on the number of capillary per muscle fiber measured histochemically trought muscle biopsy.
|
3 month
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- ReCaP
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .