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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date June 2022
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Swimming participants in the 6-hour cold water swim
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

Locations

Country Name City State
France CHU Caen Normandie Caen

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Caen INSERM UMR U1075 Comète GIP Cyceron, unicaen, Caen Normandie

Country where clinical trial is conducted

France, 

Outcome

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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