Injury;SportsNCT05757518
Post-exercise Recovery of DOMS in Recreational Athletes
A study testing Cryosauna in people with Injury;Sports, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 20 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Injury;Sports
- What is being tested?
- Cryosauna
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePoland
- Study dates
- 16 Jan 2023to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- no previous experience with cryostimulation using a cryo-sauna,
- recreational lifestyle.
Who cannot join
- Current or prior pain or injury in the lower extremity.
- Previous history of surgery in the lower extremity.
- Cardiovascular disabilities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cryosauna for Post-exercise Recovery of Delayed Onset Muscle Soreness (DOMS) in Recreational Athletes: a Randomized Control Trial
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.
Read the 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.
- Conditions
- Injury;Sports
- Being tested
- Cryosauna
- Keywords
- DOMS, injury prevention, performance, muscle properties
- Medical subject headings
- Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryosaunaOther
The intervention was Cryosauna - cryostimulation at -110°C for 1.5 minutes, for four consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Cryo-stimulation using cryosauna after fatigue-induced exercise. Receives: Other: Cryosauna |
| Control group | No intervention | Without any intervention after fatigue-induced exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline muscle stiffness at 96 hours after fatigue-induced exercise.
Measurement of blood markers.
Leukocytes [10^9 /L] concentration.
Measured: Change from baseline leukocytes concentration at 96 hours after fatigue-induced exercise.
Measurement of blood markers.
Creatine kinase [ng/mL] concentration.
Measured: Change from baseline creatine kinase concentration at 96 hours after fatigue-induced exercise.
Measurement of blood markers.
Myoglobin [ng/mL] concentration.
Measured: Change from baseline myoglobin concentration at 96 hours after fatigue-induced exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start16 Jan 2023
- Primary completion20 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Injury;SportsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw University of Health and Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Gdansk University of Physical Education and Sport
- Responsible party
- Principal investigator, Sebastian Klich, Wroclaw University of Health and Sport Sciences
- Investigators
- Sebastian Klich, Dr., Study director, University School of Physical Education in Wrocław
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757518
- Sponsor's protocol ID
- AWFiS#1/2023
- Other IDs
- KB-62/22
- Status last verified
- Mar 2023
- First submitted
- 11 Feb 2023
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29738892Klich 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.
PubMed 33381054Kons 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.
PubMed 32644009
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryosauna for Post-exercise Recovery of Delayed Onset Muscle Soreness (DOMS) in Recreational Athletes: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05757518
- Acronym / sponsor ID
- AWFiS#1/2023
- Conditions
- Injury;Sports
- Keywords
- DOMS, injury prevention, performance, muscle properties
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Wroclaw University of Health and Sport SciencesUniversity, hospital or other
- Collaborators
- Gdansk University of Physical Education and Sport
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: CryosaunaCryo-stimulation using cryosauna after fatigue-induced exercise. |
| Control group | No intervention | –Without any intervention after fatigue-induced exercise. |
Who may qualify
- Ages
- 20 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- no previous experience with cryostimulation using a cryo-sauna,
- recreational lifestyle.
Key exclusion criteria (3 listed)
- Current or prior pain or injury in the lower extremity.
- Previous history of surgery in the lower extremity.
- Cardiovascular disabilities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryosaunaThe intervention was Cryosauna - cryostimulation at -110°C for 1.5 minutes, for four consecutive days. | Other | Experimental group |
Primary outcome
Measurement of muscle stiffness in the lower extremity.
Time frame: Change from baseline muscle stiffness at 96 hours after fatigue-induced exercise.
Stiffness [N/m] was measured on: the anterior thigh, posterior thigh, shin, and calf muscles in 23 reference points.
Measurement of blood markers.
Time frame: Change from baseline leukocytes concentration at 96 hours after fatigue-induced exercise.
Leukocytes [10^9 /L] concentration.
Measurement of blood markers.
Time frame: Change from baseline creatine kinase concentration at 96 hours after fatigue-induced exercise.
Creatine kinase [ng/mL] concentration.
Measurement of blood markers.
Time frame: Change from baseline myoglobin concentration at 96 hours after fatigue-induced exercise.
Myoglobin [ng/mL] concentration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Background: PubMed 29738892Klich 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.
- Background: PubMed 33381054Klich 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.
- Background: PubMed 32644009Kons 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Klich, Dr. study director
University School of Physical Education in Wrocław
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryosauna in people with Injury;Sports, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of muscle stiffness in the lower extremity. (time frame: Change from baseline muscle stiffness at 96 hours after fatigue-induced exercise.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05757518, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.