NCT02598258

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

August 24, 2022

Status Verified

August 1, 2022

Enrollment Period

3.2 years

First QC Date

October 8, 2015

Last Update Submit

August 22, 2022

Conditions

Keywords

SaunaCold water bath

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    Difference between baseline and 11 minutes of intervention.

Secondary Outcomes (2)

  • Arrhytmias

    Number of arrhytmias during all 25 minutes of the intervention.

  • Blood pressure

    Measured at 10 minutes after the end of the intervention (recovery period).

Study Arms (1)

Sauna + Cold Water Bath

EXPERIMENTAL

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.

Other: Sauna and cold water bath

Interventions

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.

Sauna + Cold Water Bath

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Any cardiac condition, abnormal exercise test, hypertension, type I diabetes and presence of any medications that may affect blood pressure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Prevention and Rehabilitation Center

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Steam Bath

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BalneologyTherapeuticsHyperthermia, Induced

Study Officials

  • Martin Juneau

    EPIC Centrer - Montreal Heart Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professeur agrégé de clinique

Study Record Dates

First Submitted

October 8, 2015

First Posted

November 5, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 30, 2021

Last Updated

August 24, 2022

Record last verified: 2022-08

Locations