Hemodynamic Effects of Dry Sauna Followed by Cold Water Immersion in Healthy Subjects

Blood Pressure Clinical Trial

Official title:

Hemodynamic Effects of Dry Sauna Followed by Cold Water Immersion in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02598258
• Other study ID #: 15-1807
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: December 30, 2021

Study information

• Verified date: August 2022
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 30, 2021
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias
• Arrhythmias, Cardiac
• Blood Pressure

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	Cardiovascular Prevention and Rehabilitation Center	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Montreal Heart Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure		Difference between baseline and 11 minutes of intervention.
Secondary	Arrhytmias	Patients will use a HOLTER during all experiment. Total time: 25 minutes.	Number of arrhytmias during all 25 minutes of the intervention.
Secondary	Blood pressure		Measured at 10 minutes after the end of the intervention (recovery period).