- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Şehitkamil
-
Gaziantep, Şehitkamil, Tyrkia (Türkiye)
- Gaziantep University, Faculty of Sports Sciences, Sports Performance and Testing Laboratory
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Sham-komparator: 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. |
|
Eksperimentell: 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. |
|
Eksperimentell: 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. |
|
Ingen inngripen: Control
No recovery procedure is performed after the EIMD protocol; only measurements are taken. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Peak Power ( 60°/s)
Tidsramme: 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
|
|
Peak Power ( 180°/s)
Tidsramme: 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
|
|
Average Power ( 180°/s- 60°/s)
Tidsramme: 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
|
|
Serum creatine kinase (CK)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
H/Q ratio
Tidsramme: The 48-hour period before and after EIMD in each phase
|
Hamstring-to-quadriceps peak torque ratio (60°/s and 180°/s) |
The 48-hour period before and after EIMD in each phase
|
|
VAS
Tidsramme: During each period: before EIMD, immediately after EIMD, and 48 hours after EIMD
|
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
|
|
Fatique Index
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2026/9504
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
"Individual participant data will not be shared for privacy reasons; aggregate results will be published."
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