- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Şehitkamil
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Gaziantep, Şehitkamil, Turecko (Türkiye)
- Gaziantep University, Faculty of Sports Sciences, Sports Performance and Testing Laboratory
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Falešný srovnávač: 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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Experimentální: 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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Experimentální: 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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Žádný zásah: Control
No recovery procedure is performed after the EIMD protocol; only measurements are taken. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Peak Power ( 60°/s)
Časové okno: The 48-hour period before and after EIMD in each phase
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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)
Časové okno: 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)
Časové okno: The 48-hour period before and after EIMD in each phase
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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)
Časové okno: The 48-hour period before and after EIMD in each phase
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CK level in venous blood (U/L) |
The 48-hour period before and after EIMD in each phase
|
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Myoglobin (Mb)
Časové okno: The 48-hour period before and after EIMD in each phase
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Myoglobin level in venous blood (ng/mL) |
The 48-hour period before and after EIMD in each phase
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Lactate dehydrogenase (LDH)
Časové okno: The 48-hour period before and after EIMD in each phase
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LDH level in venous blood (U/L) |
The 48-hour period before and after EIMD in each phase
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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H/Q ratio
Časové okno: 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
Časové okno: 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
Časové okno: The 48-hour period before and after EIMD in each phase
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Fatigue index (%) calculated from a test consisting of 10 cycles at 180°/s |
The 48-hour period before and after EIMD in each phase
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 2026/9504
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
"Individual participant data will not be shared for privacy reasons; aggregate results will be published."
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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