Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT05757518
Status:
COMPLETED
Last Update Posted:
2023-03-07
First Post:
2023-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-exercise Recovery of DOMS in Recreational Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001265', 'term': 'Athletic Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-03', 'studyFirstSubmitDate': '2023-02-11', 'studyFirstSubmitQcDate': '2023-03-03', 'lastUpdatePostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of muscle stiffness in the lower extremity.', 'timeFrame': 'Change from baseline muscle stiffness at 96 hours after fatigue-induced exercise.', 'description': 'Stiffness \\[N/m\\] was measured on: the anterior thigh, posterior thigh, shin, and calf muscles in 23 reference points.'}, {'measure': 'Measurement of blood markers.', 'timeFrame': 'Change from baseline leukocytes concentration at 96 hours after fatigue-induced exercise.', 'description': 'Leukocytes \\[10\\^9 /L\\] concentration.'}, {'measure': 'Measurement of blood markers.', 'timeFrame': 'Change from baseline creatine kinase concentration at 96 hours after fatigue-induced exercise.', 'description': 'Creatine kinase \\[ng/mL\\] concentration.'}, {'measure': 'Measurement of blood markers.', 'timeFrame': 'Change from baseline myoglobin concentration at 96 hours after fatigue-induced exercise.', 'description': 'Myoglobin \\[ng/mL\\] concentration.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DOMS', 'injury prevention', 'performance', 'muscle properties'], 'conditions': ['Injury;Sports']}, 'referencesModule': {'references': [{'pmid': '29738892', 'type': 'BACKGROUND', '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.'}, {'pmid': '33381054', 'type': 'BACKGROUND', '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.'}, {'pmid': '32644009', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '26 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* no previous experience with cryostimulation using a cryo-sauna,\n* recreational lifestyle.\n\nExclusion Criteria:\n\n* Current or prior pain or injury in the lower extremity.\n* Previous history of surgery in the lower extremity.\n* Cardiovascular disabilities.'}, 'identificationModule': {'nctId': 'NCT05757518', 'briefTitle': 'Post-exercise Recovery of DOMS in Recreational Athletes', 'organization': {'class': 'OTHER', 'fullName': 'Wroclaw University of Health and Sport Sciences'}, 'officialTitle': 'Cryosauna for Post-exercise Recovery of Delayed Onset Muscle Soreness (DOMS) in Recreational Athletes: a Randomized Control Trial', 'orgStudyIdInfo': {'id': 'AWFiS#1/2023'}, 'secondaryIdInfos': [{'id': 'KB-62/22', 'type': 'OTHER', 'domain': 'Regional Medical Society in Gdynia'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Cryo-stimulation using cryosauna after fatigue-induced exercise.', 'interventionNames': ['Other: Cryosauna']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Without any intervention after fatigue-induced exercise.'}], 'interventions': [{'name': 'Cryosauna', 'type': 'OTHER', 'description': 'The intervention was Cryosauna - cryostimulation at -110°C for 1.5 minutes, for four consecutive days.', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80-336', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Physical Exercise Laboratory', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}], 'overallOfficials': [{'name': 'Sebastian Klich, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University School of Physical Education in Wrocław'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wroclaw University of Health and Sport Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gdansk University of Physical Education and Sport', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Director', 'investigatorFullName': 'Sebastian Klich', 'investigatorAffiliation': 'Wroclaw University of Health and Sport Sciences'}}}}