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Completed

NCT Number: NCT06296290

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Caen Normandie

Caen, 14000, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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).

  2. 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).

  3. Duration

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

    Duration of the swimming

  4. Individual characteristics, gender

    Time frame: One evaluation assessed the day before the race

    The variable collected was the gender of participants

  5. Individual characteristics, age

    Time frame: One evaluation assessed the day before the race

    The variable collected was the age of participants

  6. 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Acronym: CARDIOCOLD

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 6, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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