Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-01-11 @ 10:55 AM
Study NCT ID:
NCT02498366
Status:
UNKNOWN
Last Update Posted:
2015-07-15
First Post:
2015-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exertional Rhabdomyolysis- Characterization of Prediction Tests for Return to Duty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012206', 'term': 'Rhabdomyolysis'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-14', 'studyFirstSubmitDate': '2015-07-13', 'studyFirstSubmitQcDate': '2015-07-14', 'lastUpdatePostDateStruct': {'date': '2015-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'creatine phosphokinase (CPK)', 'timeFrame': '5 experiment days for each subject', 'description': 'CPK is a marker for muscle damage assessed in blood test. blood sample will be taken before and after step test and running on the anaerobic threshold test.'}, {'measure': 'oxygen consumption (VO2)', 'timeFrame': '5 experiment days for each subject', 'description': 'VO2 will be monitored continuously using a metabolic system (ERGOTEST 680, ZAN, GERMANY ) during VO2max test, step test and running on the anaerobic threshold test.'}], 'secondaryOutcomes': [{'measure': 'lactic acid', 'timeFrame': '5 experiment days for each subject', 'description': 'lactic acid level is assessed from blood drop (finger sting), will be taken before and after every test. lactic acid is a marker for anaerobic effort evaluating.'}, {'measure': 'Myoglobin', 'timeFrame': '5 experiment days for each subject', 'description': 'marker from urine sample, taken before and after step test and running on the anaerobic threshold test.'}, {'measure': 'Heart rate', 'timeFrame': '5 experiment days for each subject', 'description': 'The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rhabdomyolysis']}, 'descriptionModule': {'briefSummary': 'In order to determine norm values for skeleton muscle disassembly due to physical exertion in healthy and trained population, and developing a prediction test for approval for rhabdomyolysis injuries to return to duty, 50 healthy subjects will undergo a series of different physical tests.', 'detailedDescription': '50 healthy civilians volunteers will be recruited for this study. Each subject will undergo the physical tests: anthropometric measurements, wingate test, VO2max test, step test and running on the anaerobic threshold, on separate days. Blood sample, lactic acid level (measured in blood drop - finger sting) and urine sample will be taken before and after every test.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy civilians ages 18-30.\n* above average aerobic and anaerobic fitness.\n* Without heart, cardiovascular, metabolic or respiratory illnesses.\n* Without known medical illness or medication use that might endanger the participants.\n\nExclusion Criteria:\n\n* existence of any of undesired conditions detailed in the inclusion criteria.\n* the physician decision.'}, 'identificationModule': {'nctId': 'NCT02498366', 'briefTitle': 'Exertional Rhabdomyolysis- Characterization of Prediction Tests for Return to Duty', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Exertional Rhabdomyolysis- Characterization of Prediction Tests for Return to Duty', 'orgStudyIdInfo': {'id': '2388-15-SMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental protocol', 'description': '50 healthy, male, trained and aged 18-30 will be recruited and asked to undergo a series of physical tests.', 'interventionNames': ['Other: physical tests']}], 'interventions': [{'name': 'physical tests', 'type': 'OTHER', 'description': 'each subject will undergo the following physical tests: day 1 - anthropometric measurements, wingate test and after 1 hour rest VO2max test. lactic acid levels will be measured before and after both tests.\n\nday 2 - step test day 3 - running on the anaerobic threshold. blood sample, lactic acid level (measured in blood drop - finger sting) and urine sample will be taken before and after every test in days 2 and 3.', 'armGroupLabels': ['experimental protocol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Litwinsky', 'state': 'Ramat- Gan', 'country': 'Israel', 'facility': 'Sheba medical center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}], 'centralContacts': [{'name': 'Ofir Frenkel, M.D', 'role': 'CONTACT', 'phone': '+972529243399'}], 'overallOfficials': [{'name': 'Ofir Frenkel, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}