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

Hypothermia Clinical Trial

— CARDIOCOLD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06296290
• Other study ID #: CARDIOCOLD
• Status: Completed
• Start date: June 4, 2022
• Est. completion date: August 15, 2022

Study information

• Verified date: February 2024
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 15, 2022
• Est. primary completion date: June 6, 2022
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypothermia

Locations

Country	Name	City	State
France	CHU Caen Normandie	Caen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Caen	INSERM UMR U1075 Comète GIP Cyceron, unicaen, Caen Normandie

Country where clinical trial is conducted

France, 

Outcome

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