- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05409560
Core Temperature Afterdrop in Cold-water Swimming (THERMOCOLD)
Analysis of Core Temperature Afterdrop and Factors Associated With Afterdrop in Cold-water Swimming
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.
The 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Caen, France, 14000
- CHU Caen Normandie
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- swimmers taking part in the Channel Swim Camp
- swimmers above 18 years of age
- swimmers willing and able to give informed consent for participation in the study
Exclusion Criteria:
- swallowing disorder
- chronic gastrointestinal disease
- MRI scheduled within 48 hours after the race.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cold water swimmers
swimmers participating in the 6-hour cold water swim, qualifying for the English Channel Swim
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Body Core Temperature
Time Frame: Continuous measurement was collected from 30 minutes before the race until 2 hours after the end of the race for each swimmer
|
Measurement of Body Core Temperature using an ingestible electronic sensor (e-Celsius®, BodyCap , Caen, France) which provide a continuous validated measurement
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Continuous measurement was collected from 30 minutes before the race until 2 hours after the end of the race for each swimmer
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body composition, fat-free mass
Time Frame: One measurement assessed the day before the race
|
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).
|
One measurement assessed the day before the race
|
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Body composition, muscle mass
Time Frame: One measurement assessed the day before the race
|
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).
|
One measurement assessed the day before the race
|
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Body composition, body mass
Time Frame: One measurement assessed the day before the race
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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).
|
One measurement assessed the day before the race
|
|
Distance
Time Frame: The distance of swimming was collected from the organisers immediately after the race
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Distance of the swimming
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The distance of swimming was collected from the organisers immediately after the race
|
|
Duration
Time Frame: The duration of swimming was collected from the organisers immediately after the race
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Duration of the swimming
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The duration of swimming was collected from the organisers immediately after the race
|
|
Individual characteristics, gender
Time Frame: One evaluation assessed the day before the race
|
The variable collected was the gender of participants
|
One evaluation assessed the day before the race
|
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Individual characteristics, age
Time Frame: One evaluation assessed the day before the race
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The variables collected was the age of participants
|
One evaluation assessed the day before the race
|
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Individual characteristics, swimming habits
Time Frame: One evaluation assessed the day before the race
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The variables collected was the swimming distance per week (total, swimming pool and open water)
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One evaluation assessed the day before the race
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Individual characteristics, training in cold environment
Time Frame: One evaluation assessed the day before the race
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The variable collected was the type of specific training in cold environment (yes/no)
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One evaluation assessed the day before the race
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- THERMOCOLD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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