Thermoregulation During a 25-km Open Water Race

Hypothermia Due to Cold Environment Clinical Trial

— THERMO25  

Official title:

Changes in Body Core Temperature During a 25-km Open Water Race in Elite Swimmers: Identifying Predictors for Hypothermia and Dropouts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04460339
• Other study ID #: THERMO25
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: June 3, 2020

Study information

• Verified date: July 2020
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Open water swimming is a swimming discipline which takes place in outdoor water such as open oceans, lakes, and rivers. Elite swimmers are exposed to hypothermia when swimming in cold water, especially in long duration races, such as the 25-km race. The objective of this study is to evaluate the change in body core temperature in swimmers with continuous temperature monitoring during a 25-km race. The secondary objective is to identify the predictors of hypothermia and hypothermia-related drop-out.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 3, 2020
• Est. primary completion date: May 26, 2019
• Gender: All
• Age group: 15 Years to 45 Years

Eligibility

Inclusion Criteria:

• competitors of the 25-km French Open Water Championship

• participants who volunteered for this study

• written consent was obtained from all participants, as well as their legal representatives when applicable (i.e. parents for under age participants).

Exclusion Criteria:

• swallowing disorders

• transit disorders

• MRI scheduled within 48 hours

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia Due to Cold Environment

Intervention

Other:
• Swimming participants in the 25-km
The 25-km race was the French national Open Championship event and participants were the swimmers registered for the race who volunteered to participate in this study

Locations

Country	Name	City	State
France	CHU Caen Normandie	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

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-Celsius®, 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
Primary	Change in Water Temperature	Measurement of the Water Temperature using an electronic sensor (iButton® Maxim Integrated) 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	Body mass (in kg) was measured using bioelectrical impedance analysis (mBCA 525, Seca, Germany).	One measurement assessed the day before the race
Secondary	Body composition, fat 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	Perception of Cold	Immediately at the end of the race participants' perception of cold was assessed using the Cold Discomfort Scale (CDS, with rating from 0-to-10 over 10, where 0 indicates no experience of cold and 10 indicates unbearable cold)	One measurement assessed immediately at the end of the race
Secondary	Performance	Time at each lap and swimming race timing was collected using the official swimming timing from the race organisers and French Federation	Time at each lap of 2500m and at the end of the race
Secondary	Dropout rate	Swimmers who dropout were identified and cause for dropout was collected	During the swimming race and data were collected immediately after dropout for each swimmer who dropped out