Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-03-01 @ 9:58 AM
Study NCT ID:
NCT02497495
Status:
COMPLETED
Last Update Posted:
2015-07-14
First Post:
2015-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behaviour After Exercise of Biological, Clinical and Metabolic Variables as From Different Temperatures and Times of Immersion Cold Water Application
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059352', 'term': 'Musculoskeletal Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-10', 'studyFirstSubmitDate': '2015-07-07', 'studyFirstSubmitQcDate': '2015-07-10', 'lastUpdatePostDateStruct': {'date': '2015-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Creatine kinase using 5 ml samples of blood at 96 hours', 'timeFrame': '24, 48, 72 and 96 hours after exercise protocol'}, {'measure': 'Change from Baseline in Lactate by means of 25 μl of arterial blood from the ear lobe at 74 minutes', 'timeFrame': '3, 5, 7, 9, 11, 13, 15, 30, 45, 60 and 75 minutes of achievement of recuperative technique'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in leg pain using the Visual Analogue Scale at 96 hours', 'timeFrame': '24, 48, 72 and 96 hours after exercise protocol'}, {'measure': 'Change from Baseline in Perception recovery through the scale of perceived effort Likert at 96 hours', 'timeFrame': '75 minutes, 24, 48, 72 and 96 hours after exercise protocol'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Immersion', 'Recovery of Function', 'Lactate', 'Creatine Kinase', 'Musculoskeletal Pain'], 'conditions': ['Cryotherapy Effect']}, 'descriptionModule': {'briefSummary': "Introduction: immersion cold water is a recuperative strategy commonly used, however, are not yet fully understood the real effects of this technique on specific conditions. Objective: To analyze and to compare the effects of the immersion cold water during the intense post-exercise recovery, using different times and temperatures on biological, clinical and metabolic variables. Method: 105 male subjects were divided into five groups: one control group (CG) and four recoveries (G1: 5' at 9±1 degrees Celsius; G2: 5' at 14±1 degrees Celsius; G3: 15' at 9±1 degrees Celsius; G4: 15' at 14±1 degrees Celsius). The volunteers were submitted an exhaustion protocol that consisted of a program of jumps and the Wingate test. Immediately after the exhaustion protocol, volunteers were directed to a tank with water and ice, which were immersed up to the height of the anterior superior iliac spine to the recovery procedure, during which blood samples were collected for later analysis lactate and creatine kinase (CK). Variables were collected prior to the exercise, 24, 48, 72 and 96 hours after the end of it. Furthermore, the perception of pain and recovery of the lower limbs were also collected at specific moments by means respectively of the Likert scale of perceived effort and visual analogue scale pain. Appropriate statistical analysis was used to compare the groups and the moments, considering the 5% level of significance."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male sex\n* Healthy\n* Aged between 18 and 30 years\n* Classified as physically active through the International Physical Activity Questionnaire\n\nExclusion Criteria:\n\n* Anemia\n* Inflammation\n* Diabetes\n* Cardiovascular disease\n* Liver problems\n* Alcoholics\n* Smokers\n* Illicit drug users\n* Chronic users of anti-inflammatory drugs\n* Episode of musculotendinous or osteoarticular injury in the lower and/or column members during the last six months.'}, 'identificationModule': {'nctId': 'NCT02497495', 'briefTitle': 'Behaviour After Exercise of Biological, Clinical and Metabolic Variables as From Different Temperatures and Times of Immersion Cold Water Application', 'organization': {'class': 'OTHER', 'fullName': 'Paulista University'}, 'officialTitle': 'Effects Post-exercise of Biological, Clinical and Metabolic Variables as From Different Temperatures and Times of Immersion Cold Water Application in Active Individuals', 'orgStudyIdInfo': {'id': '736.438'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'GC', 'description': 'Control group - CG (n = 21), which suffered no recuperative technique'}, {'type': 'EXPERIMENTAL', 'label': 'G1', 'description': 'G1 (n = 21) was subjected to a recovery procedure by immersion cold water for 5 minutes as from 9±1 degrees Celsius', 'interventionNames': ['Other: immersion cold water']}, {'type': 'EXPERIMENTAL', 'label': 'G2', 'description': 'G2 (n = 21) was subjected to a recovery procedure by immersion cold water for 5 minutes as from 14±1 degrees Celsius', 'interventionNames': ['Other: immersion cold water']}, {'type': 'EXPERIMENTAL', 'label': 'G3', 'description': 'G3 (n = 21) was subjected to a recovery procedure by immersion cold water for 15 minutes as from 9±1 degrees Celsius', 'interventionNames': ['Other: immersion cold water']}, {'type': 'EXPERIMENTAL', 'label': 'G4', 'description': 'G4 (n = 21) was subjected to a recovery procedure by immersion cold water for 15 minutes as from 14±1 degrees Celsius', 'interventionNames': ['Other: immersion cold water']}], 'interventions': [{'name': 'immersion cold water', 'type': 'OTHER', 'description': 'immersion cold water at different temperatures and exposure times', 'armGroupLabels': ['G1', 'G2', 'G3', 'G4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55', 'city': 'Presidente Prudente', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Franciele Marques Vanderlei', 'geoPoint': {'lat': -22.12556, 'lon': -51.38889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paulista University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Franciele Marques Vanderle', 'investigatorAffiliation': 'Paulista University'}}}}