Post-exercise Recovery of DOMS in Recreational Athletes
Primary Purpose
Injury;Sports
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Cryosauna
Sponsored by
About this trial
This is an interventional screening trial for Injury;Sports focused on measuring DOMS, injury prevention, performance, muscle properties
Eligibility Criteria
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.
Sites / Locations
- Physical Exercise Laboratory
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
Cryo-stimulation using cryosauna after fatigue-induced exercise.
Without any intervention after fatigue-induced exercise.
Outcomes
Primary Outcome Measures
Measurement of muscle stiffness in the lower extremity.
Stiffness [N/m] was measured on: the anterior thigh, posterior thigh, shin, and calf muscles in 23 reference points.
Measurement of blood markers.
Leukocytes [10^9 /L] concentration.
Measurement of blood markers.
Creatine kinase [ng/mL] concentration.
Measurement of blood markers.
Myoglobin [ng/mL] concentration.
Secondary Outcome Measures
Full Information
NCT ID
NCT05757518
First Posted
February 11, 2023
Last Updated
March 3, 2023
Sponsor
Wroclaw University of Health and Sport Sciences
Collaborators
Gdansk University of Physical Education and Sport
1. Study Identification
Unique Protocol Identification Number
NCT05757518
Brief Title
Post-exercise Recovery of DOMS in Recreational Athletes
Official Title
Cryosauna for Post-exercise Recovery of Delayed Onset Muscle Soreness (DOMS) in Recreational Athletes: a Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 16, 2023 (Actual)
Primary Completion Date
January 20, 2023 (Actual)
Study Completion Date
January 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wroclaw University of Health and Sport Sciences
Collaborators
Gdansk University of Physical Education and Sport
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injury;Sports
Keywords
DOMS, injury prevention, performance, muscle properties
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
InvestigatorOutcomes Assessor
Masking Description
Participants will be allocated to intervention (cryostimulation using cryosauna) or a control group (without any intervention) using a randomized list of allocated numbers generated by a computer program. The investigator and Outcomes Assessor will be blinded to the allocation process.
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Cryo-stimulation using cryosauna after fatigue-induced exercise.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Without any intervention after fatigue-induced exercise.
Intervention Type
Other
Intervention Name(s)
Cryosauna
Intervention Description
The intervention was Cryosauna - cryostimulation at -110°C for 1.5 minutes, for four consecutive days.
Primary Outcome Measure Information:
Title
Measurement of muscle stiffness in the lower extremity.
Description
Stiffness [N/m] was measured on: the anterior thigh, posterior thigh, shin, and calf muscles in 23 reference points.
Time Frame
Change from baseline muscle stiffness at 96 hours after fatigue-induced exercise.
Title
Measurement of blood markers.
Description
Leukocytes [10^9 /L] concentration.
Time Frame
Change from baseline leukocytes concentration at 96 hours after fatigue-induced exercise.
Title
Measurement of blood markers.
Description
Creatine kinase [ng/mL] concentration.
Time Frame
Change from baseline creatine kinase concentration at 96 hours after fatigue-induced exercise.
Title
Measurement of blood markers.
Description
Myoglobin [ng/mL] concentration.
Time Frame
Change from baseline myoglobin concentration at 96 hours after fatigue-induced exercise.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Klich, Dr.
Organizational Affiliation
University School of Physical Education in Wrocław
Official's Role
Study Director
Facility Information:
Facility Name
Physical Exercise Laboratory
City
Gdańsk
ZIP/Postal Code
80-336
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29738892
Citation
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.
Results Reference
background
PubMed Identifier
33381054
Citation
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.
Results Reference
background
PubMed Identifier
32644009
Citation
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. 2023 Sep;22(9):1079-1094. doi: 10.1080/14763141.2020.1779335. Epub 2020 Jul 9.
Results Reference
background
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Post-exercise Recovery of DOMS in Recreational Athletes
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