HypothermiaCARDIOCOLDNCT06296290
Impact of Prolonged Cold-water Swimming on Heart Rate and Cardiac Function
An observational study of Hypothermia, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypothermia
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jun 2022to 15 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Swimmers participating in the 6-hour cold-water swim, qualifying for the English Channel swim at the Channel Swim Camp (Dinard, France).
Who may be able to join
- 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
Who cannot join
- swallowing disorder
- chronic gastrointestinal disease
- MRI scheduled within 48 hours after the race.
- known cardiac arythmia or cardiovascular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hypothermia
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Heart rate from a resting ECG recording
Waves, intervals \& segments of the normal ECG trace was collected
Measured: 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
Measured: 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
Measured: 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
Measured: 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
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).
Measured: One measurement assessed the day before the race
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).
Measured: One measurement assessed the day before the race
Duration
Duration of the swimming
Measured: The duration of swimming was collected from the organisers immediately after the race
Individual characteristics, gender
The variable collected was the gender of participants
Measured: One evaluation assessed the day before the race
Individual characteristics, age
The variable collected was the age of participants
Measured: One evaluation assessed the day before the race
Individual characteristics, training in cold environment
The variable collected was the type of specific training in cold environment (yes/no)
Measured: One evaluation assessed the day before the race
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start4 Jun 2022
- Primary completion6 Jun 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296290
- Sponsor's protocol ID
- CARDIOCOLD
- Acronym
- CARDIOCOLD
- Status last verified
- Feb 2024
- First submitted
- 29 Feb 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Prolonged Cold-water Swimming on Heart Rate and Cardiac Function in Healthy Swimmers.
- ClinicalTrials.gov ID
- NCT06296290
- Acronym / sponsor ID
- CARDIOCOLD / CARDIOCOLD
- Conditions
- Hypothermia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 4 Jun 2022 (actual)
- Primary completion
- 6 Jun 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Swimmers participating in the 6-hour cold-water swim, qualifying for the English Channel swim at the Channel Swim Camp (Dinard, France).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- swallowing disorder
- chronic gastrointestinal disease
- MRI scheduled within 48 hours after the race.
- known cardiac arythmia or cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
6 secondary outcomes
Body composition, body fat mass
Time frame: One measurement assessed the day before the race
Body composition, fat-free mass
Time frame: One measurement assessed the day before the race
Duration
Time frame: 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
Individual characteristics, age
Time frame: One evaluation assessed the day before the race
Individual characteristics, training in cold environment
Time frame: One evaluation assessed the day before the race
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothermia, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.