- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07926763
Inspiratory Muscle Training Plus Cold Water Immersion After Muscle-Damaging Exercise
The Combined Effect of Cold Water Immersion and Inspiratory Muscle Training on the Recovery From Exercise-Induced Muscle Damage and Physical Performance: A Randomized, Placebo-Controlled Crossover Study
The purpose of this study is to examine, using a placebo-controlled design, the additional effect of inspiratory muscle training (IMT) added to cold water immersion (CWI) on recovery and muscle performance following exercise-induced muscle damage (EIMD), and to determine whether this effect varies depending on the timing of the intervention. The study will include 12 healthy male athletes aged 18-22 who have been licensed for at least 4 years and are actively involved in sports. Each participant will undergo four different interventions in a randomized order determined by the Williams balanced sequence following muscle damage induced by eccentric exercise on an isokinetic dynamometer: CWI + placebo IMT immediately after exercise, IMT + CWI immediately after exercise, IMT + CWI 24 hours after exercise, and a control condition with no recovery intervention. The sessions will be conducted in weekly cycles with 7-day intervals, alternating between the dominant and non-dominant legs; thus, there will be a 14-day interval between two loading sessions for the same leg. All measurements will be taken during the week. Muscle strength will be assessed using an isokinetic dynamometer; markers of muscle damage (CK, myoglobin, LDH) will be measured via blood samples; and muscle pain will be evaluated using the Visual Analog Scale (VAS) before each exercise session and 48 hours after exercise.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Şehitkamil
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Gaziantep, Şehitkamil, Turquía (Türkiye)
- Gaziantep University, Faculty of Sports Sciences, Sports Performance and Testing Laboratory
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Be a male between the ages of 18 and 22
- Hold a sports license valid for at least 4 years
- Be actively involved in sports
- Not smoke or use similar substances
Exclusion Criteria:
- Having sustained a sports injury within the past 2 years
- Having engaged in exercise that could cause muscle damage within the past 15 days
- Cold intolerance, cold urticaria, or Raynaud's phenomenon
- Known cardiovascular, respiratory, or musculoskeletal disease
- Use of anti-inflammatory medication or dietary supplements that could affect recovery during the study period
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador falso: CWI + placebo IMT
Device: Placebo IMT - 2 × 30 breaths at 15% of MIP using POWERbreathe (1 min between sets), immediately following the short test after EIMD. Other: Immersion in cold water - immediately following the placebo IMT, in 10-12 °C water, up to waist level or with legs fully submerged, for 10-15 minutes. |
Immersion up to the waist in water at 13-15 °C for 13-15 minutes in a portable ice bath; water temperature is monitored with a thermometer and maintained by adding ice. Same device, position and volume as inspiratory muscle training (two sets of 30 breaths, 1 minute rest), but at 15% of maximal inspiratory pressure, a load considered below the training threshold. Followed immediately by cold water immersion. |
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Experimental: IMT + CWI (immediately)
Other: Inspiratory muscle training + cold water immersion. Immediately following the short test after EIMD, 2 × 30 breaths at 40% of MIP using POWERbreathe (1 min rest between sets), followed by CWI. |
Immersion up to the waist in water at 13-15 °C for 13-15 minutes in a portable ice bath; water temperature is monitored with a thermometer and maintained by adding ice. Two sets of 30 breaths at 40% of maximal inspiratory pressure with 1 minute rest between sets, using a POWERbreathe device; oxygen saturation is monitored by pulse oximetry. Followed immediately by cold water immersion. |
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Experimental: IMT + CWI (at 24 hours)
Other: Inspiratory muscle training + cold water immersion. The same IMT and CWI protocol is administered 24 hours after EIMD; the 48-hour measurement is taken relative to EIMD (24 hours after the intervention). |
Immersion up to the waist in water at 13-15 °C for 13-15 minutes in a portable ice bath; water temperature is monitored with a thermometer and maintained by adding ice. Two sets of 30 breaths at 40% of maximal inspiratory pressure with 1 minute rest between sets, using a POWERbreathe device; oxygen saturation is monitored by pulse oximetry. Followed immediately by cold water immersion. |
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Sin intervención: Control
No recovery procedure is performed after the EIMD protocol; only measurements are taken. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Peak Power ( 60°/s)
Periodo de tiempo: The 48-hour period before and after EIMD in each phase
|
Highest torque (Nm) measured during a 5-rep maximum test on an isokinetic dynamometer |
The 48-hour period before and after EIMD in each phase
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Peak Power ( 180°/s)
Periodo de tiempo: The 48-hour period before and after EIMD in each phase
|
Highest torque (Nm) measured during a 10-rep maximum test on an isokinetic dynamometer |
The 48-hour period before and after EIMD in each phase
|
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Average Power ( 180°/s- 60°/s)
Periodo de tiempo: The 48-hour period before and after EIMD in each phase
|
Average of peak torque values during test repetitions (Nm) |
The 48-hour period before and after EIMD in each phase
|
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Serum creatine kinase (CK)
Periodo de tiempo: The 48-hour period before and after EIMD in each phase
|
CK level in venous blood (U/L) |
The 48-hour period before and after EIMD in each phase
|
|
Myoglobin (Mb)
Periodo de tiempo: The 48-hour period before and after EIMD in each phase
|
Myoglobin level in venous blood (ng/mL) |
The 48-hour period before and after EIMD in each phase
|
|
Lactate dehydrogenase (LDH)
Periodo de tiempo: The 48-hour period before and after EIMD in each phase
|
LDH level in venous blood (U/L) |
The 48-hour period before and after EIMD in each phase
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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H/Q ratio
Periodo de tiempo: The 48-hour period before and after EIMD in each phase
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Hamstring-to-quadriceps peak torque ratio (60°/s and 180°/s) |
The 48-hour period before and after EIMD in each phase
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VAS
Periodo de tiempo: During each period: before EIMD, immediately after EIMD, and 48 hours after EIMD
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0-10 cm Visual Analog Scale (0 = no pain, 10 = very severe pain) |
During each period: before EIMD, immediately after EIMD, and 48 hours after EIMD
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Fatique Index
Periodo de tiempo: The 48-hour period before and after EIMD in each phase
|
Fatigue index (%) calculated from a test consisting of 10 cycles at 180°/s |
The 48-hour period before and after EIMD in each phase
|
Colaboradores e Investigadores
Patrocinador
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
Otros números de identificación del estudio
- 2026/9504
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
"Individual participant data will not be shared for privacy reasons; aggregate results will be published."
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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