NCT06296290

Brief Summary

A significant medical risk associated with hypothermia during exercise in a cold environment cardiac arrhythmia due to a possible autonomic conflict. However, little is known about the changes in heart rate and cardiac function after prolonged cold water swimming. The investigators propose to measure the changes in core temperarure during and after a cold water swim at at a water temperature below 15.5°C qualifying for English Channel swim and to test the association with changes in heart rate variability, resting electrocardiogram and left ventricle function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 4, 2022

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 29, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
Last Updated

September 19, 2024

Status Verified

February 1, 2024

Enrollment Period

2 days

First QC Date

February 29, 2024

Last Update Submit

September 17, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Heart rate from a resting ECG recording

    Waves, intervals \& segments of the normal ECG trace was collected

    Two Time points (1) the day before the race and (2) at 30 min after ending the race

  • Heart rate from a 5-minute ECG recording

    Heart rate variability (HRV) parameters including time-domain measures and frequency-time measures

    Two Time points (1) the day before the race and (2) at 30 min after ending the race

  • Transthoracic echocardiography (TTE) analysis

    Left and right ventricular and atrial dimensions, and systolic and diastolic ventricular function assessment were collected

    Two Time points (1) the day before the race and (2) at 30 min after ending the race

  • 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

    Time Frame: Continuous measurement was collected from 30 minutes before the race until 2 hours after the end of the race for each swimmer]

Secondary Outcomes (6)

  • Body composition, body fat mass

    One measurement assessed the day before the race

  • Body composition, fat-free mass

    One measurement assessed the day before the race

  • Duration

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

  • Individual characteristics, gender

    One evaluation assessed the day before the race

  • Individual characteristics, age

    One evaluation assessed the day before the race

  • +1 more secondary outcomes

Study Arms (1)

All participants

The participants are the swimmers engaged in the 6-hour cold water swim during the Channel Swim Camp who volunteered to participate in the study.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
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.
  • known cardiac arythmia or cardiovascular disease

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

February 29, 2024

First Posted

March 6, 2024

Study Start

June 4, 2022

Primary Completion

June 6, 2022

Study Completion

August 15, 2022

Last Updated

September 19, 2024

Record last verified: 2024-02

Locations