Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 1:17 AM
Study NCT ID:
NCT05409560
Status:
COMPLETED
Last Update Posted:
2025-03-26
First Post:
2022-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Core Temperature Afterdrop in Cold-water Swimming
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007035', 'term': 'Hypothermia'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2022-04-17', 'studyFirstSubmitQcDate': '2022-06-03', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Body Core Temperature', 'timeFrame': 'Continuous measurement was collected from 30 minutes before the race until 2 hours after the end of the race for each swimmer', 'description': 'Measurement of Body Core Temperature using an ingestible electronic sensor (e-Celsius®, BodyCap , Caen, France) which provide a continuous validated measurement'}], 'secondaryOutcomes': [{'measure': 'Body composition, body mass', 'timeFrame': 'One measurement assessed the day before the race', 'description': 'Fat mass (in kg, % of body mass \\[fat mass and body mass were combined to report % of body mass) was measured using bioelectrical impedance analysis (mBCA 525, Seca, Germany).'}, {'measure': 'Body composition, fat-free mass', 'timeFrame': 'One measurement assessed the day before the race', 'description': 'Fat-free mass (in kg, % of body mass \\[fat-free mass and body mass were combined to report % of body mass) was measured using bioelectrical impedance analysis (mBCA 525, Seca, Germany).'}, {'measure': 'Body composition, muscle mass', 'timeFrame': 'One measurement assessed the day before the race', 'description': 'Muscle mass (in kg, % of body mass \\[muscle mass and body mass were combined to report % of body mass) was measured using bioelectrical impedance analysis (mBCA 525, Seca, Germany).'}, {'measure': 'Distance', 'timeFrame': 'The distance of swimming was collected from the organisers immediately after the race', 'description': 'Distance of the swimming'}, {'measure': 'Duration', 'timeFrame': 'The duration of swimming was collected from the organisers immediately after the race', 'description': 'Duration of the swimming'}, {'measure': 'Individual characteristics, gender', 'timeFrame': 'One evaluation assessed the day before the race', 'description': 'The variable collected was the gender of participants'}, {'measure': 'Individual characteristics, age', 'timeFrame': 'One evaluation assessed the day before the race', 'description': 'The variables collected was the age of participants'}, {'measure': 'Individual characteristics, swimming habits', 'timeFrame': 'One evaluation assessed the day before the race', 'description': 'The variables collected was the swimming distance per week (total, swimming pool and open water)'}, {'measure': 'Individual characteristics, training in cold environment', 'timeFrame': 'One evaluation assessed the day before the race', 'description': 'The variable collected was the type of specific training in cold environment (yes/no)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypothermia, Accidental', 'Cold Water Swimming']}, 'descriptionModule': {'briefSummary': 'A significant risk associated with hypothermia during exercise in a cold environment is the core temperature (T°core) afterdrop, which corresponds to a continuous fall in T°core during rewarming after hypothermia. However, the rate and predictors of the afterdrop are unclear, particularly during prolonged cold water swimming.\n\nThe investigators propose to measure the changes in T°core during and after a cold water swim at 12.5-13°C qualifying for English Channel swim and to test the impact of anthropometric and swimming parameters on the duration of the T°core afterdrop. The hypotheses are that afterdrop is common during a prolonged cold water swimming event and that protective factors against T°core drop during cold water swimming (increased body fat and BMI) might, conversely, be associated with prolonged afterdrop.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Swimmers participating in the 6-hour cold-water swim, qualifying for the English Channel swim at the Channel Swim Camp (Dinard, France).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* swimmers taking part in the Channel Swim Camp\n* swimmers above 18 years of age\n* swimmers willing and able to give informed consent for participation in the study\n\nExclusion Criteria:\n\n* swallowing disorder\n* chronic gastrointestinal disease\n* MRI scheduled within 48 hours after the race.'}, 'identificationModule': {'nctId': 'NCT05409560', 'acronym': 'THERMOCOLD', 'briefTitle': 'Core Temperature Afterdrop in Cold-water Swimming', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Analysis of Core Temperature Afterdrop and Factors Associated With Afterdrop in Cold-water Swimming', 'orgStudyIdInfo': {'id': 'THERMOCOLD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cold water swimmers', 'description': 'swimmers participating in the 6-hour cold water swim, qualifying for the English Channel Swim', 'interventionNames': ['Other: Swimming participants in the 6-hour cold water swim']}], 'interventions': [{'name': 'Swimming participants in the 6-hour cold water swim', 'type': 'OTHER', 'description': 'The 6-hour cold water swim was the qualifying swim for the English Channel swim during the Channel Swim Camp Dinard 2021 and participants were the swimmers registered for the 6-hour cold water swim who volunteered to participate in this study', 'armGroupLabels': ['Cold water swimmers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'country': 'France', 'facility': 'CHU Caen Normandie', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}