- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07618455
Effects of Whole-Body HIIT and Moderate Continuous Exercise on Immune Function (WBHIIT-IMM)
Effects of Whole-Body High-Intensity Interval Training and Moderate-Intensity Continuous Exercise on Immune Function in Recreationally Active Men
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This study was designed as a two-arm, parallel-group, randomized controlled trial. A total of 20 recreationally active male participants were randomly assigned to either the Whole Body High-Intensity Interval Training (WB-HIIT) group or the Moderate-Intensity Continuous Training (MICT) group. The intervention lasted 12 weeks and involved supervised training sessions multiple times a week.
The WB-HIIT protocol consisted of repeated high-intensity whole-body exercises performed at near-maximum effort with intermittent rest periods, while the MICT group performed moderate-intensity continuous aerobic exercise. Immune function was assessed through selected hematological and biochemical markers collected at baseline and post-intervention. In addition, physical performance variables were evaluated to examine secondary adaptations to different exercise modalities. The primary aim of the study was to compare the effects of WB-HIIT and MICT on immune system responses, while secondary outcomes included changes in exercise performance. This study provides insights into how different training intensities affect immune regulation in individuals who are active in their leisure time.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Merkez
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Bitlis, Merkez, Turquía (Türkiye), 13100
- Bitlis Eren University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Healthy male adults Aged 18-25 years Not engaged in regular structured exercise training (>3 sessions/week) VO₂max within normal healthy range Willingness to participate and provide informed consent No acute or chronic inflammatory, metabolic, or cardiovascular disease
Exclusion Criteria:
Female participants (not included in study design) Smoking or alcohol abuse Use of anti-inflammatory or immunomodulatory drugs Participation in regular high-intensity training programs Musculoskeletal limitations preventing exercise testing or training Acute infection within last 2 weeks Chronic metabolic, cardiovascular, or autoimmune diseases
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Whole-Body HIIT
Participants will perform Whole-Body High-Intensity Interval Training (WB-HIIT) protocol.
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Whole-body high-intensity interval training protocol performed under supervision.
|
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Comparador activo: MICT
Participants will perform Moderate-Intensity Continuous Training (MICT) protocol.
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Moderate-intensity continuous training protocol performed under supervision.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Peripheral immune cell counts
Periodo de tiempo: Baseline and 8 weeks (post-intervention)
|
Changes in peripheral blood leukocyte, lymphocyte subsets, neutrophil, and monocyte counts from baseline to post-intervention (8 weeks).
|
Baseline and 8 weeks (post-intervention)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Inflammatory cytokine levels
Periodo de tiempo: Baseline and 8 weeks (post-intervention)
|
Changes in serum IL-6, TNF-α, and CRP levels from baseline to post-intervention (8 weeks).
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Baseline and 8 weeks (post-intervention)
|
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Immunoglobulin levels
Periodo de tiempo: Baseline and 8 weeks (post-intervention)
|
Changes in serum immunoglobulin (IgA, IgG, IgM) concentrations from baseline to post-intervention (8 weeks).
|
Baseline and 8 weeks (post-intervention)
|
|
Cortisol levels
Periodo de tiempo: Baseline and 8 weeks (post-intervention)
|
Changes in serum cortisol levels as a marker of exercise-induced stress response from baseline to post-intervention (8 weeks).
|
Baseline and 8 weeks (post-intervention)
|
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Maximal oxygen uptake (VO₂max)
Periodo de tiempo: Baseline and 8 weeks (post-intervention)
|
Changes in VO₂max measured by cardiopulmonary exercise testing from baseline to post-intervention.
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Baseline and 8 weeks (post-intervention)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Melih Çalışır, PhD, Bitlis Eren Üniversitesi University
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
Otros números de identificación del estudio
- 2020-189
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
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