Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-28 @ 5:43 PM
Study NCT ID:
NCT02064361
Status:
COMPLETED
Last Update Posted:
2014-02-17
First Post:
2014-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Intensity Cycling Before SCUBA Diving Reduces Post-decompression Microparticle Production and Neutrophil Activation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003665', 'term': 'Decompression Sickness'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001469', 'term': 'Barotrauma'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-13', 'studyFirstSubmitDate': '2014-02-12', 'studyFirstSubmitQcDate': '2014-02-13', 'lastUpdatePostDateStruct': {'date': '2014-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline values of number of circulating microparticles per microliter of blood', 'timeFrame': 'Prior to exercise, prior to diving, 15 and 120 minutes after surfacing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['SCUBA diving', 'exercise,', 'microparticles', 'neutrophil activation,', 'high intensity exercise'], 'conditions': ['Decompression Sickness', 'SCUBA Diving']}, 'referencesModule': {'references': [{'pmid': '23493363', 'type': 'BACKGROUND', 'citation': 'Thom SR, Milovanova TN, Bogush M, Yang M, Bhopale VM, Pollock NW, Ljubkovic M, Denoble P, Madden D, Lozo M, Dujic Z. Bubbles, microparticles, and neutrophil activation: changes with exercise level and breathing gas during open-water SCUBA diving. J Appl Physiol (1985). 2013 May 15;114(10):1396-405. doi: 10.1152/japplphysiol.00106.2013. Epub 2013 Mar 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the impact of high intensity,anaerobic exercise, in the form of cycling, on SCUBA diving. Outcomes are determined by the quantification and subtype of circulating microparticles, complete blood counts, and the quantification of venous gas emboli, measured via transthoracic echocardiography, in the cardiac cavities.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Experienced divers (\\> 250 logged dives)\n* Male\n* Physician clearance to dive\n\nExclusion Criteria:\n\n* Prior incidence of decompression sickness'}, 'identificationModule': {'nctId': 'NCT02064361', 'briefTitle': 'High Intensity Cycling Before SCUBA Diving Reduces Post-decompression Microparticle Production and Neutrophil Activation', 'organization': {'class': 'OTHER', 'fullName': 'University of Split'}, 'officialTitle': 'High Intensity Cycling Before SCUBA Diving Reduces Post-decompression Microparticle Production and Neutrophil Activation', 'orgStudyIdInfo': {'id': 'SCUBACYC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High intensity exercise', 'description': 'A dive to 18 meters sea water for a duration of 41 minutes preceded by high intensity cycling', 'interventionNames': ['Other: High intensity exercise']}], 'interventions': [{'name': 'High intensity exercise', 'type': 'OTHER', 'description': 'Subjects performed a repeated Wingate protocol for the exercise condition of the study. This consisted of 4, 30 s maximal efforts on a weight-braked cycle ergometer (Monark 894E, Monark Exercise AB, Sweden) with 4 min active recovery between efforts, preceded by a 5 min warm up. The resistance was set at 7.5% bodyweight for the intervals and 2% for the warm up and active recovery periods.', 'armGroupLabels': ['High intensity exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21000', 'city': 'Split', 'state': 'Dalmatia', 'country': 'Croatia', 'facility': 'University of Split School of Medicine', 'geoPoint': {'lat': 43.50891, 'lon': 16.43915}}], 'overallOfficials': [{'name': 'Zeljko Dujic, MD. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Split'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Split', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Maryland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Zeljko Dujic MD, PhD', 'investigatorFullName': 'Zeljko Dujic', 'investigatorAffiliation': 'University of Split'}}}}