THERMO25: Thermoregulation During a 25-km Open Water Race

Sponsor
University Hospital, Caen (Other)
Overall Status
Completed
CT.gov ID
NCT04460339
Collaborator
(none)
24
1
15.1
1.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Swimming participants in the 25-km

Study Design

Study Type:
Observational
Actual Enrollment :
24 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Changes in Body Core Temperature During a 25-km Open Water Race in Elite Swimmers: Identifying Predictors for Hypothermia and Dropouts
Actual Study Start Date :
Mar 1, 2019
Actual Primary Completion Date :
May 26, 2019
Actual Study Completion Date :
Jun 3, 2020

Outcome Measures

Primary Outcome Measures

  1. Change in Body Core Temperature [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-CelsiusĀ®, BodyCap , Caen, France) which provide a continuous validated measurement

  2. Change in Water Temperature [Continuous measurement was collected from 30 minutes before the race until 2 hours after the end of the race for each swimmer]

    Measurement of the Water Temperature using an electronic sensor (iButtonĀ® Maxim Integrated) which provide a continuous validated measurement

Secondary Outcome Measures

  1. Body composition, body mass [One measurement assessed the day before the race]

    Body mass (in kg) was measured using bioelectrical impedance analysis (mBCA 525, Seca, Germany).

  2. Body composition, fat mass [One measurement assessed the day before the race]

    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).

  3. Body composition, fat-free mass [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).

  4. Body composition, muscle mass [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).

  5. Perception of Cold [One measurement assessed immediately at the end of the race]

    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)

  6. Performance [Time at each lap of 2500m and at the end of the race]

    Time at each lap and swimming race timing was collected using the official swimming timing from the race organisers and French Federation

  7. Dropout rate [During the swimming race and data were collected immediately after dropout for each swimmer who dropped out]

    Swimmers who dropout were identified and cause for dropout was collected

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 45 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Caen Normandie Caen France 14000

Sponsors and Collaborators

  • University Hospital, Caen

Investigators

  • Principal Investigator: Joffrey Drigny, MD MSC, CHU Caen Normandie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joffrey DRIGNY, Principal Investigator, Chief Resident, University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT04460339
Other Study ID Numbers:
  • THERMO25
First Posted:
Jul 7, 2020
Last Update Posted:
Jul 7, 2020
Last Verified:
Jul 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2020