NCT05409560

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 21, 2021

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
Last Updated

March 26, 2025

Status Verified

June 1, 2022

Enrollment Period

2 days

First QC Date

April 17, 2022

Last Update Submit

March 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (9)

  • Body composition, body 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

  • Distance

    The distance of swimming was collected from the organisers immediately after the race

  • Duration

    The duration of swimming was collected from the organisers immediately after the race

  • +4 more secondary outcomes

Study Arms (1)

Cold water swimmers

swimmers participating in the 6-hour cold water swim, qualifying for the English Channel Swim

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

Interventions

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

Cold water swimmers

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Swimmers participating in the 6-hour cold-water swim, qualifying for the English Channel swim at the Channel Swim Camp (Dinard, France).

You may qualify if:

  • 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

You may not qualify if:

  • swallowing disorder
  • chronic gastrointestinal disease
  • MRI scheduled within 48 hours after the race.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Caen Normandie

Caen, 14000, France

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2022

First Posted

June 8, 2022

Study Start

May 21, 2021

Primary Completion

May 23, 2021

Study Completion

August 19, 2021

Last Updated

March 26, 2025

Record last verified: 2022-06

Locations