- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Şehitkamil
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Gaziantep, Şehitkamil, Turquie (Türkiye)
- Gaziantep University, Faculty of Sports Sciences, Sports Performance and Testing Laboratory
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur factice: 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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Expérimental: 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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Expérimental: 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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Aucune intervention: Control
No recovery procedure is performed after the EIMD protocol; only measurements are taken. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Peak Power ( 60°/s)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
H/Q ratio
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 2026/9504
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
"Individual participant data will not be shared for privacy reasons; aggregate results will be published."
Informations sur les médicaments et les dispositifs, documents d'étude
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