Thermoregulation During a 25-km Open Water Race
THERMO25
Changes in Body Core Temperature During a 25-km Open Water Race in Elite Swimmers: Identifying Predictors for Hypothermia and Dropouts
1 other identifier
observational
24
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 3, 2020
CompletedFirst Submitted
Initial submission to the registry
June 27, 2020
CompletedFirst Posted
Study publicly available on registry
July 7, 2020
CompletedMarch 26, 2025
July 1, 2020
3 months
June 27, 2020
March 24, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (7)
Body composition, body mass
One measurement assessed the day before the race
Body composition, fat mass
One measurement assessed the day before the race
Body composition, fat-free mass
One measurement assessed the day before the race
Body composition, muscle mass
One measurement assessed the day before the race
Perception of Cold
One measurement assessed immediately at the end of the race
- +2 more secondary outcomes
Interventions
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
Eligibility Criteria
All the competitors of the 25-km French Open Water Championship who volunteered for this study
You may qualify if:
- 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).
You may not qualify if:
- swallowing disorders
- transit disorders
- MRI scheduled within 48 hours
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Caen Normandie
Caen, 14000, France
Study Officials
- PRINCIPAL INVESTIGATOR
Joffrey Drigny, MD MSC
CHU Caen Normandie
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2020
First Posted
July 7, 2020
Study Start
March 1, 2019
Primary Completion
May 26, 2019
Study Completion
June 3, 2020
Last Updated
March 26, 2025
Record last verified: 2020-07