Hypothermia, Accidental Clinical Trial
— THERMOCOLDOfficial title:
Analysis of Core Temperature Afterdrop and Factors Associated With Afterdrop in Cold-water Swimming
| NCT number | NCT05409560 |
| Other study ID # | THERMOCOLD |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 21, 2021 |
| Est. completion date | August 19, 2021 |
| Verified date | June 2022 |
| Source | University Hospital, Caen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 15 |
| Est. completion date | August 19, 2021 |
| Est. primary completion date | May 23, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Caen Normandie | Caen |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Caen | INSERM UMR U1075 Comète GIP Cyceron, unicaen, Caen Normandie |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Body Core Temperature | Measurement of Body Core Temperature using an ingestible electronic sensor (e-CelsiusĀ®, BodyCap , Caen, France) which provide a continuous validated measurement | Continuous measurement was collected from 30 minutes before the race until 2 hours after the end of the race for each swimmer | |
| Secondary | Body composition, body mass | 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 | |
| Secondary | Body composition, fat-free mass | 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 | |
| Secondary | Body composition, muscle mass | 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 | |
| Secondary | Distance | Distance of the swimming | The distance of swimming was collected from the organisers immediately after the race | |
| Secondary | Duration | Duration of the swimming | The duration of swimming was collected from the organisers immediately after the race | |
| Secondary | Individual characteristics, gender | The variable collected was the gender of participants | One evaluation assessed the day before the race | |
| Secondary | Individual characteristics, age | The variables collected was the age of participants | One evaluation assessed the day before the race | |
| Secondary | Individual characteristics, swimming habits | The variables collected was the swimming distance per week (total, swimming pool and open water) | One evaluation assessed the day before the race | |
| Secondary | Individual characteristics, training in cold environment | The variable collected was the type of specific training in cold environment (yes/no) | One evaluation assessed the day before the race |
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