- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05757518
Post-exercise Recovery of DOMS in Recreational Athletes
Cryosauna for Post-exercise Recovery of Delayed Onset Muscle Soreness (DOMS) in Recreational Athletes: a Randomized Control Trial
Study Overview
Detailed Description
The main goal of this study was to investigate the effectiveness of cryo-sauna in preventing the development of DOMS in the lower extremity. The second goal is to analyze the rate of regenerative changes in the right muscles after acute fatigue-induced exercises.
This study design was a randomized, controlled single-blind trial with repeated measures. Moreover, the design was prepared according to the Consolidated Standards of Reporting Trials (CONSORT) for pragmatic trials. Participants were assigned into two groups: (1) experimental group (CRYO, n =16) - cryostimulation using a cryo sauna; and (2) control group (CONT, n = 15) - without any intervention. This study was conducted in the Physical Exercise Laboratory. Both groups, CRYO and CON performed a fatigue-induced protocol consisting of counter-movement jumps (CMJ) (10 set for 10 repetitions). After the fatigue exercises, only CRYO underwent cryo sauna intervention including entry immediately after, 24, 48, and 72 hours post-exercise. The order of measurements at baseline included: blood sample testing (creatine kinase, myoglobin, leukocytes) and muscle stiffness of the lower extremity. All measurements we collected at baseline, immediately post, 24, 48, 72, and 96 hours post-exercise.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Gdańsk, Poland, 80-336
- Physical Exercise Laboratory
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- no previous experience with cryostimulation using a cryo-sauna,
- recreational lifestyle.
Exclusion Criteria:
- Current or prior pain or injury in the lower extremity.
- Previous history of surgery in the lower extremity.
- Cardiovascular disabilities.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental group
Cryo-stimulation using cryosauna after fatigue-induced exercise.
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The intervention was Cryosauna - cryostimulation at -110°C for 1.5 minutes, for four consecutive days.
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No Intervention: Control group
Without any intervention after fatigue-induced exercise.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of muscle stiffness in the lower extremity.
Time Frame: Change from baseline muscle stiffness at 96 hours after fatigue-induced exercise.
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Stiffness [N/m] was measured on: the anterior thigh, posterior thigh, shin, and calf muscles in 23 reference points.
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Change from baseline muscle stiffness at 96 hours after fatigue-induced exercise.
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Measurement of blood markers.
Time Frame: Change from baseline leukocytes concentration at 96 hours after fatigue-induced exercise.
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Leukocytes [10^9 /L] concentration.
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Change from baseline leukocytes concentration at 96 hours after fatigue-induced exercise.
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Measurement of blood markers.
Time Frame: Change from baseline creatine kinase concentration at 96 hours after fatigue-induced exercise.
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Creatine kinase [ng/mL] concentration.
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Change from baseline creatine kinase concentration at 96 hours after fatigue-induced exercise.
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Measurement of blood markers.
Time Frame: Change from baseline myoglobin concentration at 96 hours after fatigue-induced exercise.
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Myoglobin [ng/mL] concentration.
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Change from baseline myoglobin concentration at 96 hours after fatigue-induced exercise.
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Sebastian Klich, Dr., University School of Physical Education in Wrocław
Publications and helpful links
General Publications
- Klich S, Krymski I, Michalik K, Kawczynski A. Effect of short-term cold-water immersion on muscle pain sensitivity in elite track cyclists. Phys Ther Sport. 2018 Jul;32:42-47. doi: 10.1016/j.ptsp.2018.04.022. Epub 2018 May 1.
- Klich S, Ficek K, Krymski I, Klimek A, Kawczynski A, Madeleine P, Fernandez-de-Las-Penas C. Quadriceps and Patellar Tendon Thickness and Stiffness in Elite Track Cyclists: An Ultrasonographic and Myotonometric Evaluation. Front Physiol. 2020 Dec 14;11:607208. doi: 10.3389/fphys.2020.607208. eCollection 2020.
- Kons RL, Orssatto LBDR, Sakugawa RL, da Silva Junior JN, Diefenthaeler F, Detanico D. Effects of stretch-shortening cycle fatigue protocol on lower limb asymmetry and muscle soreness in judo athletes. Sports Biomech. 2020 Jul 9:1-16. doi: 10.1080/14763141.2020.1779335. Online ahead of print.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AWFiS#1/2023
- KB-62/22 (Other Identifier: Regional Medical Society in Gdynia)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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