An interventional study of Cold Water Immersion and Inspiratory Muscle Training in Exercise Fatigue, Cold Water Immersion and Inspiratory Muscle Training, sponsored by University of Gaziantep. Not yet recruiting at 1 site in Turkey (Türkiye). Open to male participants aged 18 Years to 22 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by University of Gaziantep · Not applicable, Interventional, and Other
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.
2,229 studies on the registry are indexed under Fatigue; 426 are open to participants now.
This study's planned enrollment of 12 is below the median of 54 across 1,757 interventional studies indexed under Fatigue.
Browse Fatigue studies →University of Gaziantep is the lead sponsor of 105 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
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.
Other: Cold Water Immersion · Other: Sham Inspiratory Muscle Training
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.
Other: Cold Water Immersion · Other: Inspiratory Muscle Training
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).
Other: Cold Water Immersion · Other: Inspiratory Muscle Training
No recovery procedure is performed after the EIMD protocol; only measurements are taken.
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.
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.
Peak Power ( 60°/s)
Highest torque (Nm) measured during a 5-rep maximum test on an isokinetic dynamometer
Time frame: The 48-hour period before and after EIMD in each phase
Peak Power ( 180°/s)
Highest torque (Nm) measured during a 10-rep maximum test on an isokinetic dynamometer
Time frame: The 48-hour period before and after EIMD in each phase
Average Power ( 180°/s- 60°/s)
Average of peak torque values during test repetitions (Nm)
Time frame: The 48-hour period before and after EIMD in each phase
Serum creatine kinase (CK)
CK level in venous blood (U/L)
Time frame: The 48-hour period before and after EIMD in each phase
Myoglobin (Mb)
Myoglobin level in venous blood (ng/mL)
Time frame: The 48-hour period before and after EIMD in each phase
Lactate dehydrogenase (LDH)
LDH level in venous blood (U/L)
Time frame: The 48-hour period before and after EIMD in each phase
H/Q ratio
Hamstring-to-quadriceps peak torque ratio (60°/s and 180°/s)
Time frame: The 48-hour period before and after EIMD in each phase
VAS
0-10 cm Visual Analog Scale (0 = no pain, 10 = very severe pain)
Time frame: During each period: before EIMD, immediately after EIMD, and 48 hours after EIMD
Fatique Index
Fatigue index (%) calculated from a test consisting of 10 cycles at 180°/s
Time frame: The 48-hour period before and after EIMD in each phase
Plan to share: No — "Individual participant data will not be shared for privacy reasons; aggregate results will be published."
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2026, 0 months later.
Of 936 non-industry interventional studies with no phase under Fatigue, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's planned 0 months is below that.
Counting every sponsor, half of 989 studies reached it within 11 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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