Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-04-23 @ 9:55 PM
Study NCT ID:
NCT02677402
Status:
COMPLETED
Last Update Posted:
2016-10-27
First Post:
2016-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Various Modalities Water Immersion on Veins
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007101', 'term': 'Immersion'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'lastUpdateSubmitDate': '2016-10-25', 'studyFirstSubmitDate': '2016-01-10', 'studyFirstSubmitQcDate': '2016-02-08', 'lastUpdatePostDateStruct': {'date': '2016-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in common femoral vein cross-section (mm2) during three immersion modalities immersion', 'timeFrame': 'Change from Baseline at 16 min of immersion in 3 modalities, doppler ultrasound measurements', 'description': 'thermo neutral water immersion (TNI), cold water immersion (CWI) and contrast water therapy (CWT)'}, {'measure': 'change in great saphenous vein antero posterior diameter (mm) during three immersion modalities immersion', 'timeFrame': 'Baseline at 16 min of immersion in 3 modalities, doppler ultrasound measurements', 'description': 'thermo neutral water immersion (TNI), cold water immersion (CWI) and contrast water therapy (CWT)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['femoral vein', 'saphenous vein', 'hydrostatic pressure', 'temperature', 'recovery'], 'conditions': ['Hydrotherapy']}, 'descriptionModule': {'briefSummary': 'Objectives In this study the investigators examined the changes in common femoral vein (CFV) and great saphenous vein (GSV) calibre during thermo neutral water immersion (TNI), cold water immersion (CWI) and contrast water therapy (CWT).\n\nDesign Ten professional handball players visited the laboratory on three occasions. At each visit, participants completed a 20-minutes procedure in an upright position: 4-minutes in air (baseline) and then 16-minutes lower limbs TNI (\\~35°C), CWI (\\~12°C) or CWT (2:2minutes (\\~12°C to \\~35°C) ratio), selected randomly.\n\nMethods CFV and GVS calibres were evaluated by echo Doppler measures at baseline and at the end of 16 min immersion.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Free healthy voluntary\n\nExclusion Criteria:\n\n* hypersensitivity to cold'}, 'identificationModule': {'nctId': 'NCT02677402', 'briefTitle': 'Effects of Various Modalities Water Immersion on Veins', 'organization': {'class': 'OTHER', 'fullName': 'University of Franche-Comté'}, 'officialTitle': 'Effects of Thermo Neutral Water Immersion, Cold-water Immersion and Contrast Water Therapy on Lower Limb Veins Calibres', 'orgStudyIdInfo': {'id': 'H2O'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cold water immersion', 'description': 'Participants immersed their lower limbs in water of \\~12°C', 'interventionNames': ['Other: immersion']}, {'type': 'EXPERIMENTAL', 'label': 'contrast water therapy', 'description': 'Participants immersed their lower limbs in water : alternated every 2 min between \\~12°C and \\~35°C for CWT', 'interventionNames': ['Other: immersion']}, {'type': 'EXPERIMENTAL', 'label': 'thermo neutral immersion', 'description': 'Participants immersed their lower limbs in water of \\~35°C', 'interventionNames': ['Other: immersion']}], 'interventions': [{'name': 'immersion', 'type': 'OTHER', 'armGroupLabels': ['cold water immersion', 'contrast water therapy', 'thermo neutral immersion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'country': 'France', 'facility': 'Beliard', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'overallOfficials': [{'name': 'Samuel Beliard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Franche-Comte'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Franche-Comté', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Laurent Mourot', 'investigatorAffiliation': 'University of Franche-Comté'}}}}