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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05757518
Other study ID # AWFiS#1/2023
Secondary ID KB-62/22
Status Completed
Phase N/A
First received
Last updated
Start date January 16, 2023
Est. completion date January 31, 2023

Study information

Verified date March 2023
Source University School of Physical Education in Wroclaw
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date January 31, 2023
Est. primary completion date January 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 26 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Cryosauna
The intervention was Cryosauna - cryostimulation at -110°C for 1.5 minutes, for four consecutive days.

Locations

Country Name City State
Poland Physical Exercise Laboratory Gdansk

Sponsors (2)

Lead Sponsor Collaborator
University School of Physical Education in Wroclaw Gdansk University of Physical Education and Sport

Country where clinical trial is conducted

Poland, 

References & Publications (3)

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. — View 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. — View 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. 2020 Jul 9:1-16. doi: 10.1080/14763141.2020.1779335. Online ahead of print. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change from baseline muscle stiffness at 96 hours after fatigue-induced exercise.
Primary Measurement of blood markers. Leukocytes [10^9 /L] concentration. Change from baseline leukocytes concentration at 96 hours after fatigue-induced exercise.
Primary Measurement of blood markers. Creatine kinase [ng/mL] concentration. Change from baseline creatine kinase concentration at 96 hours after fatigue-induced exercise.
Primary Measurement of blood markers. Myoglobin [ng/mL] concentration. Change from baseline myoglobin concentration at 96 hours after fatigue-induced exercise.
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