- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07566832
Velocity-Based Resistance Training Effects on Inflammation in Older Adults
4 de mayo de 2026 actualizado por: National Taipei University
Dose-Response Effects of Velocity-Based Resistance Training on Anti-Inflammatory Responses in Older Adults
This study aims to investigate the effects of resistance training (RT) with different training volumes on immune modulation and anti-inflammatory responses in older adults.
Participants will be randomly assigned to one of three RT volume groups (low, medium, or high) or a non-exercise control group.
Participants in the training groups will complete a 4-week RT program, followed by a 4-week detraining phase.
The findings are expected to provide evidence for volume-specific RT prescriptions to support healthy aging.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
60
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Shun-Hsi Tsai, Ph.D.
- Número de teléfono: 68523 +88686741111
- Correo electrónico: shunhsi@mail.ntpu.edu.tw
Ubicaciones de estudio
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Taipei, Taiwán, 116
- Reclutamiento
- National Taiwan Normal University
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Contacto:
- Hung-Wen Liu, Ph.D.
- Número de teléfono: +88677496863
- Correo electrónico: hwliu@ntnu.edu.tw
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Contacto:
- Kuan-Tsen Yeh, M.S.
- Número de teléfono: +886932815383
- Correo electrónico: mickyyehyeh@gmail.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Aged 60-75 years or older
- No regular resistance training habit (defined as ≥2 sessions per week) in the past year
- No musculoskeletal injuries within the past six months
Exclusion Criteria:
- Obesity (BMI > 30 kg/m²), diabetes, hypertension, cancer, heart, kidney, or liver disease, or any other condition that may influence study outcomes.
- Regular use of anti-inflammatory medications (e.g., NSAIDs).
- Smoking or alcohol abuse
- Inability to safely perform the prescribed resistance exercise movements
- Unable to fully comprehend the study information and instructions.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: low training volume resistance exercise
Participants assigned to the low-volume resistance training group will perform one set per exercise at a load corresponding to 80% of 1RM.
Each set will be terminated when movement velocity decreases by 30% from the first repetition.
Rest intervals of 2-3 minutes will be provided between exercises.
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The RT program will consist of 12 sessions over a 4-week period, with participants training three times per week and at least one rest day between sessions.
All sessions will be supervised by research personnel to ensure proper technique and safety.
Exercises will be performed using resistance machines and will include chest press, shoulder press, seated row, lat pulldown, and leg press.
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Experimental: medium training volume resistance exercise
Participants assigned to the medium-volume resistance training group will perform three sets per exercise at 80% of 1RM.
Each set will be terminated when movement velocity decreases by 30% relative to the first repetition.
Rest intervals of 90 seconds will be provided between sets, and 2-3 minutes between exercises.
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The RT program will consist of 12 sessions over a 4-week period, with participants training three times per week and at least one rest day between sessions.
All sessions will be supervised by research personnel to ensure proper technique and safety.
Exercises will be performed using resistance machines and will include chest press, shoulder press, seated row, lat pulldown, and leg press.
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Experimental: high training volume resistance exercise
Participants assigned to the high-volume resistance training group will perform five sets per exercise at 80% of 1RM.
Each set will be terminated when movement velocity decreases by 30% relative to the first repetition.
Rest intervals of 90 seconds will be provided between sets, and 2-3 minutes between exercises.
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The RT program will consist of 12 sessions over a 4-week period, with participants training three times per week and at least one rest day between sessions.
All sessions will be supervised by research personnel to ensure proper technique and safety.
Exercises will be performed using resistance machines and will include chest press, shoulder press, seated row, lat pulldown, and leg press.
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Sin intervención: sedentary control
Participants in control trial stayed sedentary during the period.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in IL-6 concentration
Periodo de tiempo: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Plasma IL-6 concentrations will be measured and reported in pg/mL.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Changes in soluble IL-6 receptor concentration
Periodo de tiempo: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Soluble IL-6 receptor concentrations will be measured and reported in ng/mL.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Changes in soluble gp130 concentration
Periodo de tiempo: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Soluble gp130 concentrations will be measured and reported in ng/mL.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Changes in IL-10 concentration
Periodo de tiempo: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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IL-10 concentrations will be measured and reported in pg/mL.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Changes in IL-1RA concentration
Periodo de tiempo: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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IL-1RA concentrations will be measured and reported in pg/mL.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Changes in TNF-α concentration
Periodo de tiempo: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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TNF-α concentrations will be measured and reported in pg/mL.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Borgs Ratings of Perceived Exertion (RPE)
Periodo de tiempo: 1-hour during each exercise intervention
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Borgs RPE is a method of estimating exertion rating, based on a 1 to 10 rating scale (1 being the no exertion at all, 10 being maximal exertion).
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1-hour during each exercise intervention
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Handgrip strength
Periodo de tiempo: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Maximal handgrip strength will be assessed using a digital hand dynamometer and reported in kilograms.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Knee extension strength
Periodo de tiempo: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Maximal voluntary isometric and isokinetic concentric knee extension strength of the dominant leg will be assessed using an isokinetic dynamometer and reported in Newton-meters.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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30-second chair-stand test
Periodo de tiempo: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Lower-body functional capacity will be assessed by the number of repetitions completed during a 30-second chair-stand test.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Single-leg balance test
Periodo de tiempo: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Balance performance will be assessed as the duration of single-leg stance and reported in seconds.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Timed up and go test
Periodo de tiempo: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Functional mobility will be assessed using the Timed Up and Go test, with performance quantified as the time (seconds) required to stand up from a seated position, walk 3 meters, turn, walk back, and sit down.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Changes in SHIP1 protein expression in peripheral blood mononuclear cells (PBMCs)
Periodo de tiempo: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Intracellular SHIP1 protein expression in PBMCs will be measured and reported in arbitrary units.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Changes in gp130 (CD130) protein expression in PBMCs
Periodo de tiempo: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Intracellular gp130 (CD130) protein expression in PBMCs will be measured and reported in arbitrary units.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Changes in STAT3 protein expression in PBMCs
Periodo de tiempo: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Intracellular STAT3 protein expression in PBMCs will be measured and reported in arbitrary units.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Changes in phosphorylated STAT3 protein expression in PBMCs
Periodo de tiempo: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Intracellular phosphorylated STAT3 (p-STAT3) protein expression in PBMCs will be measured and reported in arbitrary units.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Changes in IL-6 receptor alpha (CD126) protein expression in PBMCs
Periodo de tiempo: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Intracellular IL-6 receptor alpha (CD126) protein expression in PBMCs will be measured and reported in arbitrary units.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Changes in Beta-2 adrenergic receptor (β2-AR) protein expression in PBMCs
Periodo de tiempo: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Intracellular β2-adrenergic receptor (β2-AR) protein expression in PBMCs will be measured and reported in arbitrary units.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Changes in SOCS3 protein expression in PBMCs
Periodo de tiempo: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Intracellular SOCS3 protein expression in PBMCs will be measured and reported in arbitrary units.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Changes in white blood cell count
Periodo de tiempo: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Total white blood cell count will be measured and reported in cells/μL.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Changes in lymphocyte count
Periodo de tiempo: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Lymphocyte count will be measured and reported in cells/μL.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Changes in neutrophil count
Periodo de tiempo: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Neutrophil count will be measured and reported in cells/μL.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Changes in monocyte count
Periodo de tiempo: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Monocyte count will be measured and reported in cells/μL.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Body fat percentage
Periodo de tiempo: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Body fat percentage will be measured using a body composition analyzer and reported as a percentage.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Lean body mass
Periodo de tiempo: Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Total lean body mass will be measured using a body composition analyzer and reported in kilograms.
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Baseline, post-intervention (4 weeks), and at 2 and 4 weeks during detraining
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Shun-Hsi Tsai, Ph.D., National Taipei University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
20 de abril de 2026
Finalización primaria (Estimado)
1 de marzo de 2029
Finalización del estudio (Estimado)
1 de diciembre de 2029
Fechas de registro del estudio
Enviado por primera vez
15 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de abril de 2026
Publicado por primera vez (Actual)
5 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
4 de mayo de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Actividad motora
- Movimiento
- Fenómenos fisiológicos musculoesqueléticos
- Fenómenos fisiológicos musculoesqueléticos y neuronales
- Terapéutica
- Modalidades de fisioterapia
- Atención al paciente
- Terapia de ejercicio
- Rehabilitación
- Cuidado por los convalecientes
- Continuidad de la atención al paciente
- Acondicionamiento físico, humano
- Ejercicio
- Entrenamiento de resistencia
Otros números de identificación del estudio
- ECKIRB1140803
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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