Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-01-23 @ 12:11 AM
Study NCT ID:
NCT01906203
Status:
COMPLETED
Last Update Posted:
2014-11-26
First Post:
2013-07-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Indices of Body Composition During Ultramarathon : Measure by Body Bioelectrical Impedance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-25', 'studyFirstSubmitDate': '2013-07-11', 'studyFirstSubmitQcDate': '2013-07-19', 'lastUpdatePostDateStruct': {'date': '2014-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference of fat-free mass, using bioelectrical impedance analysis', 'timeFrame': 'before and after ultramarathon of 105 km (at day 1)'}], 'secondaryOutcomes': [{'measure': 'Difference of phase angle, using bioelectrical impedance analysis', 'timeFrame': 'at day 1(before and after ultramarathon)'}, {'measure': 'Correlation between order in the course,duration of course and indices of body composition', 'timeFrame': 'at day 1 (during ultramarathon of 105 km)'}]}, 'conditionsModule': {'keywords': ['Ultramarathon', 'bioelectrical impedance', 'Phase-Angle'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'Prospective cohort, monocentric non-randomized and interventional clinical study in ICU assessing the evolution of body composition using bioelectrical impedance analysis.', 'detailedDescription': 'Prospective, monocentric non-randomized and interventional clinical study in ICU assessing the evolution of body composition using bioelectrical impedance analysis (phase angle, fat mass, muscle mass, fat-free mass, body water) before and after ultramarathon.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participation to ultramarathon\n\nExclusion Criteria:\n\n* pregnancy women'}, 'identificationModule': {'nctId': 'NCT01906203', 'acronym': 'IMPETRAIL', 'briefTitle': 'Evaluation of Indices of Body Composition During Ultramarathon : Measure by Body Bioelectrical Impedance', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Evaluation of Indices of Body Composition During Ultramarathon : Measure by Body Bioelectrical Impedance', 'orgStudyIdInfo': {'id': 'CHU-0163'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ultramarathon', 'interventionNames': ['Device: body bioelectrical impedance performed by Z-Métrix (class IIa) - BIOPARHOM 12 allée des lacs de garde, Savoie Technolac BP 238, 73374 Bourget du lac, France']}], 'interventions': [{'name': 'body bioelectrical impedance performed by Z-Métrix (class IIa) - BIOPARHOM 12 allée des lacs de garde, Savoie Technolac BP 238, 73374 Bourget du lac, France', 'type': 'DEVICE', 'armGroupLabels': ['ultramarathon']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Sébastien PERBET', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Estaing', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}