- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02598258
Hemodynamic Effects of Dry Sauna Followed by Cold Water Immersion in Healthy Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
To determine the safety on sauna followed by cold water bath, a common practice in many countries, 30 healthy subjects aged 40 years and older will be at the Montreal Heart Institute Prevention and Cardiac Rehabilitation centre. A recent complete evaluation will have excluded any cardiac condition. Subjects will first spend 10 minutes in a dry sauna at 85 degrees celtius. Immediately after , subjects will be immersed in a cold water bath (ICool , Australia) at a temperature of 5 degrees celtius for approximately one minute. Blood pressure , ecg , gaz exchange and thoracic impedance will be measured during sauna and cold water bath.
Principal goal of study: to determine the safety of this practice. Secondary goals of study: to measure the blood pressure response, heart rate, presence of arrythmyas, cardiac output and cerebral perfusion during both conditions.
Primary endpoint: Change in systolic blood pressure from sauna (after 10 minutes ) to cold water (after one minute).
Physiologic measurements: continuous ECG monitoring, BP measurements at every 3 minutes during sauna and at one minute in the cold bath, gaz exchange with a portable equipment (Cosmed K4), bioimpedance and cerebral perfusion with a single frontal NIRS electrode.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada
- Cardiovascular Prevention and Rehabilitation Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy women and men aged 40 and older with a recent complete medical evaluation including a normal resting ECG and a normal symptom-limited treadmill exercise test.
Exclusion Criteria:
- Any cardiac condition, abnormal exercise test, hypertension, type I diabetes and presence of any medications that may affect blood pressure.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sauna + Cold Water Bath
Subjects will first spend 10 minutes in a dry sauna at 85 degrees celtius.
Immediately after , subjects will be immersed in a cold water bath (ICool , Australia) at a temperature of 5 degrees celtius for approximately one minute.
Blood pressure , ecg , gaz exchange and thoracic impedance will be measured during sauna and cold water bath.
|
Subjects will first spend 10 minutes in a dry sauna at 85 degrees celtius.
Immediately after, subjects will be immersed in a cold water bath (ICool , Australia) at a temperature of 5 degrees celtius for approximately one minute.
Blood pressure , ecg , gaz exchange and thoracic impedance will be measured during sauna and cold water bath.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Blood pressure
Time Frame: Difference between baseline and 11 minutes of intervention.
|
Difference between baseline and 11 minutes of intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Arrhytmias
Time Frame: Number of arrhytmias during all 25 minutes of the intervention.
|
Patients will use a HOLTER during all experiment.
Total time: 25 minutes.
|
Number of arrhytmias during all 25 minutes of the intervention.
|
|
Blood pressure
Time Frame: Measured at 10 minutes after the end of the intervention (recovery period).
|
Measured at 10 minutes after the end of the intervention (recovery period).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Martin Juneau, EPIC Centrer - Montreal Heart Institute
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 (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-1807
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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