Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 11:57 PM
Study NCT ID:
NCT03440294
Status:
COMPLETED
Last Update Posted:
2019-05-07
First Post:
2018-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wetsuit and Life Jacket Induced Effects on Spirometry and VO2 in Windsurfers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-03', 'studyFirstSubmitDate': '2018-01-31', 'studyFirstSubmitQcDate': '2018-02-14', 'lastUpdatePostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forced Vital Capacity (FVC in L) at rest.', 'timeFrame': '1 day', 'description': 'spirometry at rest'}], 'secondaryOutcomes': [{'measure': 'Forced Expiratory Volume', 'timeFrame': '1 day', 'description': 'FEV1 (in L)'}, {'measure': 'Peak Flow', 'timeFrame': '1 day', 'description': 'PF (peak flow in L/s)'}, {'measure': 'mean flow rates', 'timeFrame': '1 day', 'description': 'mean expiratory flow rates in L/ s at 75%, 50% and 25% of FVC (MEF 75, MEF 50, MEF 25).'}, {'measure': 'maximal ventilation', 'timeFrame': '1 day', 'description': 'VE (ventilation in L/min)'}, {'measure': 'carbon dioxide production', 'timeFrame': '1 day', 'description': 'VCO2 ( in L/min)'}, {'measure': 'oxygen consumption', 'timeFrame': '1 day', 'description': 'VO2 ( in L/min)'}, {'measure': 'tidal volume', 'timeFrame': '1 day', 'description': 'VT (in L)'}, {'measure': 'breathing frequency', 'timeFrame': '1 day', 'description': 'RF (in breaths/min)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['windsurfer', 'wetsuit', 'spirometry', 'cardiopulmonary exercise testing', 'lung function', 'pulmonary function', 'oxygen uptake'], 'conditions': ['Ventilation', 'Exercise']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of wearing both neoprene suit and life jacket on respiratory capacities at rest and cardiopulmonary capacities during exercise in windsurfers.', 'detailedDescription': 'Windsurfers will perform resting spirometry and exercise test on cycle ergometer until exhaustion in two conditions: with or without equipment. The investigators will measure Forced Vital Capacity, FEV1 peak flow at rest and oxygen uptake, carbon dioxide consumption, ventilation at each step of the incremental exercise and at exhaustion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 18 to 35\n* Do not contraindicate any of the investigations in the study\n* Being affiliated to a social security system\n* free, informed and written consent\n* Have already performed a cardiopulmonary exercise test without any electrocardiographic abnormality\n* Subject practicing windsurfing (whatever the level of practice (leisure or competition))\n\nExclusion Criteria:\n\n* Subjects \\< 18 years old\n* Pregnant woman\n* Inability to consent\n* Taking any of the following: oral or inhaled Beta 2 short-acting or long-acting mimetics, oral or inhaled corticosteroids, oral anti-leukotrienes.\n* Abnormalities in the resting ECG pattern'}, 'identificationModule': {'nctId': 'NCT03440294', 'acronym': 'WINDSURF', 'briefTitle': 'Wetsuit and Life Jacket Induced Effects on Spirometry and VO2 in Windsurfers', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': "Étude de l'Effet de la Combinaison néoprène et de l'équipement Individuel de Flottaison Sur la Fonction Respiratoire de Repos et Les capacités à l'Effort Chez Les véliplanchistes : étude WINDSURF", 'orgStudyIdInfo': {'id': '29BRC17.0233'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'with neoprene suit and life jacket', 'description': 'Realization of the following examinations WITH neoprene suit and life jacket :\n\n* resting standard spirometry\n* maximum exercise testing. No drug and no placebo will be used in this arm.', 'interventionNames': ['Diagnostic Test: resting standard spirometry', 'Diagnostic Test: maximum exercise testing']}, {'type': 'OTHER', 'label': 'without neoprene suit and life jacket', 'description': 'Realization of the following examinations WITHOUT neoprene suit and life jacket :\n\n* resting standard spirometry\n* maximum exercise testing. No drug and no placebo will be used in this arm.', 'interventionNames': ['Diagnostic Test: resting standard spirometry', 'Diagnostic Test: maximum exercise testing']}], 'interventions': [{'name': 'resting standard spirometry', 'type': 'DIAGNOSTIC_TEST', 'description': 'The subject (seated, bust straightened) should perform, after a slow and maximum inspiration, a forced and complete exhalation followed by a new inspiration to the total lung capacity.', 'armGroupLabels': ['with neoprene suit and life jacket', 'without neoprene suit and life jacket']}, {'name': 'maximum exercise testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Incremental exercise on cycle ergometer with 100W start for men (80W for women) for 4 minutes as part of the warm-up. Then, step increment of a 50W power for men (40W for women) lasting 2 minutes each.', 'armGroupLabels': ['with neoprene suit and life jacket', 'without neoprene suit and life jacket']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29200', 'city': 'Brest', 'country': 'France', 'facility': 'University hospital', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}], 'overallOfficials': [{'name': 'Marie Agnes Giroux-Metges, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU de Brest'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}