Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-31 @ 5:13 PM
Study NCT ID:
NCT06549933
Status:
COMPLETED
Last Update Posted:
2025-01-16
First Post:
2024-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Cryostimulation on Inflammation and Motor Functions. The Study Was Conducted to Determine the Effect of Five Days of Whole-body Cryostimulation (PBC) on Reducing Inflammation and Improving Motor Skills in Soccer Players
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Athletes undergoing regular training were divided into two groups. One of them was subjected to cryotherapy treatments, the other was a control group, not subjected to any treatments at that time.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2024-07-24', 'studyFirstSubmitQcDate': '2024-08-08', 'lastUpdatePostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IL-6 (Interleukin-6)', 'timeFrame': 'Before, after 3 days and 5 days of cryostimulation', 'description': 'Immunoenzymatic assay method using a diagnostic ELISA Kit'}, {'measure': 'TNF-alpha (Tumor necrosis factor-alpha)', 'timeFrame': 'Before, after 3 days and 5 days of cryostimulation', 'description': 'Immunoenzymatic assay method using a diagnostic ELISA Kit'}, {'measure': 'IL-10 (Interleukin-10)', 'timeFrame': 'Before, after 3, and 5 days of cryostimulation', 'description': 'Immunoenzymatic assay method using a diagnostic ELISA Kit'}, {'measure': 'CK (creatine kinase)', 'timeFrame': 'Before, after 3, and 5 days of cryostimulation', 'description': 'Immunoenzymatic assay method using a diagnostic ELISA Kit'}, {'measure': 'Cortisol', 'timeFrame': 'Before, after 3, and 5 days of cryostimulation', 'description': 'Immunoenzymatic assay method using a diagnostic ELISA Kit'}, {'measure': 'Testosterone', 'timeFrame': 'Before, after 3, and 5 days of cryostimulation', 'description': 'Immunoenzymatic assay method using a diagnostic ELISA Kit'}], 'secondaryOutcomes': [{'measure': 'Anthropometric measurments', 'timeFrame': 'Before, after 3, and 5 days of cryostimulation', 'description': 'Analysis of body composition, Tanita BC-418'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cryostimulation', 'regeneration', 'football players', 'inflammation', 'motor functions'], 'conditions': ['Rest', 'Training']}, 'descriptionModule': {'briefSummary': 'The aim of the study was to determine the effect of a 5-day PBC on reducing inflammation and improving motor skills in soccer players during the initial phase of the training period.\n\nThe five-day cryostimulation applied did not significantly affect the profile of inflammatory markers in soccer players. However, a reduction in visuo-motor reaction time (RT) was registered in PBC-treated soccer players, suggesting the potential benefits of this method in improving motor skills.', 'detailedDescription': 'Cryostimulation is one of the methods of post-exercise recovery, involving short-term (3 min) exposure of the body to extremely low temperatures, oscillating between -100°C and -190°C. The purpose of this therapy is to reduce inflammation, reduce physical and mental fatigue and use it as a passive form of preparing the body for further exercise as part of the training process.\n\nThe study was conducted to determine the effect of five days of whole-body cryostimulation (PBC) on reducing inflammation and improving motor skills in soccer players. A group of 24 football players was randomly divided into a test group (PBC; -140°C ± 20°C, 3 min, 5 days) and a control group (CON). Before the cryostimulation session, both groups were subjected to visual-motor ability tests, which were repeated on the last day of the study. Blood samples were collected at four time points (P0-1 day, P1-3 day, P2-5 day, P3-2 days after the test). Levels of creatine kinase (CK), tumor necrosis factor (TNFα), interleukins (IL-6, IL-10), testosterone (T) and cortisol (C) were determined in the samples.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '36 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* athletes\n* no previous experience with systemic cryotherapy\n* any other forms of recovery or cosmetic treatments\n\nExclusion Criteria:\n\n* alcohol or any other stimulants\n* anti-inflammation drugs\n* injuries'}, 'identificationModule': {'nctId': 'NCT06549933', 'briefTitle': 'The Effect of Cryostimulation on Inflammation and Motor Functions. The Study Was Conducted to Determine the Effect of Five Days of Whole-body Cryostimulation (PBC) on Reducing Inflammation and Improving Motor Skills in Soccer Players', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Physical Education'}, 'officialTitle': 'The Influence of Cryostimulation on Reducing Inflammation and Improving Motor Skills in Football Player', 'orgStudyIdInfo': {'id': 'Kriokomora 845/22'}, 'secondaryIdInfos': [{'id': '12622001541796', 'type': 'REGISTRY', 'domain': 'ANZCTR of Australia and New Zealand'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cryostimulation', 'description': 'Cryostimulation performed in a cryosauna for five consecutive days.', 'interventionNames': ['Other: Criostymulation']}], 'interventions': [{'name': 'Criostymulation', 'type': 'OTHER', 'description': 'Method: Cryosauna. Temperature: -160°C. Duration: 5 days. Session Timing: 9:00 a.m.\n\nSession Length: 3 minutes per day', 'armGroupLabels': ['Cryostimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61-871', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Poznań University of Physical Education', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'overallOfficials': [{'name': 'Izabela Różycka', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Poznan University of Physical Education'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Physical Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}