Impact of Prolonged Cold-water Swimming on Heart Rate and Cardiac Function (CARDIOCOLD)

February 29, 2024 updated by: Joffrey DRIGNY, University Hospital, Caen

Impact of Prolonged Cold-water Swimming on Heart Rate and Cardiac Function in Healthy Swimmers.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Caen, France, 14000
        • CHU Caen Normandie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability 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).

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • swallowing disorder
  • chronic gastrointestinal disease
  • MRI scheduled within 48 hours after the race.
  • known cardiac arythmia or cardiovascular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate from a resting ECG recording
Time Frame: Two Time points (1) the day before the race and (2) at 30 min after ending the race
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
Time Frame: Two Time points (1) the day before the race and (2) at 30 min after ending the race
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
Time Frame: Two Time points (1) the day before the race and (2) at 30 min after ending the race
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
Time Frame: Time Frame: 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-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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition, fat-free mass
Time Frame: 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).
One measurement assessed the day before the race
Duration
Time Frame: The duration of swimming was collected from the organisers immediately after the race
Duration of the swimming
The duration of swimming was collected from the organisers immediately after the race
Individual characteristics, gender
Time Frame: One evaluation assessed the day before the race
The variable collected was the gender of participants
One evaluation assessed the day before the race
Individual characteristics, training in cold environment
Time Frame: One evaluation assessed the day before the race
The variable collected was the type of specific training in cold environment (yes/no)
One evaluation assessed the day before the race
Body composition, body fat mass
Time Frame: 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).
One measurement assessed the day before the race
Individual characteristics, age
Time Frame: One evaluation assessed the day before the race
The variable collected was the age of participants
One evaluation assessed the day before the race

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2022

Primary Completion (Actual)

June 6, 2022

Study Completion (Actual)

August 15, 2022

Study Registration Dates

First Submitted

February 29, 2024

First Submitted That Met QC Criteria

February 29, 2024

First Posted (Estimated)

March 6, 2024

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARDIOCOLD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypothermia

3
Subscribe