Hemodynamic Effects of Dry Sauna Followed by Cold Water Immersion in Healthy Subjects
Primary Purpose
Blood Pressure, Arrhythmias
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sauna and cold water bath
Sponsored by
About this trial
This is an interventional prevention trial for Blood Pressure focused on measuring Sauna, Cold water bath
Eligibility Criteria
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.
Sites / Locations
- Cardiovascular Prevention and Rehabilitation Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sauna + Cold Water Bath
Arm Description
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.
Outcomes
Primary Outcome Measures
Blood pressure
Secondary Outcome Measures
Arrhytmias
Patients will use a HOLTER during all experiment. Total time: 25 minutes.
Blood pressure
Full Information
NCT ID
NCT02598258
First Posted
October 8, 2015
Last Updated
August 22, 2022
Sponsor
Montreal Heart Institute
1. Study Identification
Unique Protocol Identification Number
NCT02598258
Brief Title
Hemodynamic Effects of Dry Sauna Followed by Cold Water Immersion in Healthy Subjects
Official Title
Hemodynamic Effects of Dry Sauna Followed by Cold Water Immersion in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montreal Heart Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Arrhythmias
Keywords
Sauna, Cold water bath
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sauna + Cold Water Bath
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Sauna and cold water bath
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood pressure
Time Frame
Difference between baseline and 11 minutes of intervention.
Secondary Outcome Measure Information:
Title
Arrhytmias
Description
Patients will use a HOLTER during all experiment. Total time: 25 minutes.
Time Frame
Number of arrhytmias during all 25 minutes of the intervention.
Title
Blood pressure
Time Frame
Measured at 10 minutes after the end of the intervention (recovery period).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Juneau
Organizational Affiliation
EPIC Centrer - Montreal Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Prevention and Rehabilitation Center
City
Montreal
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
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Hemodynamic Effects of Dry Sauna Followed by Cold Water Immersion in Healthy Subjects
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