- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06296290
Impact of Prolonged Cold-water Swimming on Heart Rate and Cardiac Function (CARDIOCOLD)
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
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Caen, France, 14000
- CHU Caen Normandie
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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
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Waves, intervals & segments of the normal ECG trace was collected
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Two Time points (1) the day before the race and (2) at 30 min after ending the race
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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
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Heart rate variability (HRV) parameters including time-domain measures and frequency-time measures
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Two Time points (1) the day before the race and (2) at 30 min after ending the race
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Transthoracic echocardiography (TTE) analysis
Time Frame: Two Time points (1) the day before the race and (2) at 30 min after ending the race
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Left and right ventricular and atrial dimensions, and systolic and diastolic ventricular function assessment were collected
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Two Time points (1) the day before the race and (2) at 30 min after ending the race
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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]
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Measurement of Body Core Temperature using an ingestible electronic sensor (e-Celsius®, BodyCap , Caen, France) which provide a continuous validated measurement
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Time Frame: Continuous measurement was collected from 30 minutes before the race until 2 hours after the end of the race for each swimmer]
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body composition, fat-free mass
Time Frame: One measurement assessed the day before the race
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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).
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One measurement assessed the day before the race
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Duration
Time Frame: The duration of swimming was collected from the organisers immediately after the race
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Duration of the swimming
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The duration of swimming was collected from the organisers immediately after the race
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Individual characteristics, gender
Time Frame: One evaluation assessed the day before the race
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The variable collected was the gender of participants
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One evaluation assessed the day before the race
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Individual characteristics, training in cold environment
Time Frame: One evaluation assessed the day before the race
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The variable collected was the type of specific training in cold environment (yes/no)
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One evaluation assessed the day before the race
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Body composition, body fat mass
Time Frame: One measurement assessed the day before the race
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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).
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One measurement assessed the day before the race
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Individual characteristics, age
Time Frame: One evaluation assessed the day before the race
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The variable collected was the age of participants
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One evaluation assessed the day before the race
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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