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Sauna Bathing to Improve Vascular Health of Adults With Heart Disease

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lifestyle intervention
Sponsored by
Montreal Heart Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring flow-mediated dilation, sauna, vascular, heat

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. A history of angiographic coronary disease: ≥70% arterial diameter narrowing of at least one major epicardial coronary artery and/or prior coronary revascularization and/or documented prior acute coronary syndrome and/or perfusion defect during exercise testing or pharmacological stimulation
  2. Stable medication doses (≥4 weeks) prior to enrolment
  3. Body mass index <35 kg/m2

Exclusion Criteria:

  1. Recent (<3 months) coronary artery disease-related hospitalization or change in angina pattern
  2. Unstable angina
  3. Ejection fraction <40% and/or clinical evidence of heart failure
  4. Significant valvular heart disease
  5. Uncontrolled hypertension (>180/110 mmHg)

Sites / Locations

  • Cardiovascular Prevention and Rehabilitation Centre of the Montreal Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Sauna

Arm Description

Participants randomized to the control condition will be asked to maintain their normal daily habits.

The sauna intervention will consist of 20 to 30 minute sauna bathing sessions within a dry Finnish sauna, performed 4 times per week.

Outcomes

Primary Outcome Measures

Flow-mediated dilation
Brachial artery flow-mediated dilation in response to 5 minutes of forearm occlusion

Secondary Outcome Measures

Post-occlusion reactive hyperaemia (AUC)
Vascular conductance area-under-the-curve during reactive hyperaemia induced by 5 minutes of forearm occlusion
Post-occlusion reactive hyperaemia (Peak)
Peak vascular conductance during reactive hyperaemia induced by 5 minutes of forearm occlusion
Local skin heating-induced vasodilation
Plateau of the cutaneous vascular conductance response during local heating of the skin to 39°C

Full Information

First Posted
July 24, 2018
Last Updated
December 9, 2022
Sponsor
Montreal Heart Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03620539
Brief Title
Sauna Bathing to Improve Vascular Health of Adults With Heart Disease
Official Title
Effects of Sauna Bathing on Cerebrovascular Function in Middle-aged to Older Adults With Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 4, 2018 (Actual)
Primary Completion Date
September 12, 2022 (Actual)
Study Completion Date
September 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montreal Heart Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study is a clinical trial that will determine if sauna bathing improves blood vessel health in adults aged 50-70 years with heart disease.
Detailed Description
Mounting evidence suggests that heat therapy may improve cardiovascular health. Recent analyses of a large cohort of middle-aged to older Finnish men have established that frequent sauna bathing is associated with a reduced risk of cardiovascular mortality, of developing dementia and Alzheimer's disease, and of developing hypertension. Given the observational nature of these relationships, it remains unknown if the beneficial effects of sauna bathing can be directly attributed to heat exposure. The objective of this study is to test the primary hypothesis that 8 weeks of sauna bathing improves flow-mediated dilation, a measure of blood vessel health, in middle-aged to older adults (50-70 yrs) with stable coronary artery disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
flow-mediated dilation, sauna, vascular, heat

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants randomized to the control condition will be asked to maintain their normal daily habits.
Arm Title
Sauna
Arm Type
Experimental
Arm Description
The sauna intervention will consist of 20 to 30 minute sauna bathing sessions within a dry Finnish sauna, performed 4 times per week.
Intervention Type
Other
Intervention Name(s)
Lifestyle intervention
Intervention Description
Sauna bathing
Primary Outcome Measure Information:
Title
Flow-mediated dilation
Description
Brachial artery flow-mediated dilation in response to 5 minutes of forearm occlusion
Time Frame
Change from baseline after 8 weeks
Secondary Outcome Measure Information:
Title
Post-occlusion reactive hyperaemia (AUC)
Description
Vascular conductance area-under-the-curve during reactive hyperaemia induced by 5 minutes of forearm occlusion
Time Frame
Change from baseline after 8 weeks
Title
Post-occlusion reactive hyperaemia (Peak)
Description
Peak vascular conductance during reactive hyperaemia induced by 5 minutes of forearm occlusion
Time Frame
Change from baseline after 8 weeks
Title
Local skin heating-induced vasodilation
Description
Plateau of the cutaneous vascular conductance response during local heating of the skin to 39°C
Time Frame
Change from baseline after 8 weeks
Other Pre-specified Outcome Measures:
Title
Blood pressure
Description
Systolic blood pressure at rest
Time Frame
Change from baseline after 8 weeks
Title
Central arterial stiffness
Description
Carotid-femoral pulse wave velocity
Time Frame
Change from baseline after 8 weeks
Title
Heart rate variability
Description
Resting levels of heart rate variability
Time Frame
Change from baseline after 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A history of angiographic coronary disease: ≥70% arterial diameter narrowing of at least one major epicardial coronary artery and/or prior coronary revascularization and/or documented prior acute coronary syndrome and/or perfusion defect during exercise testing or pharmacological stimulation Stable medication doses (≥4 weeks) prior to enrolment Body mass index <35 kg/m2 Exclusion Criteria: Recent (<3 months) coronary artery disease-related hospitalization or change in angina pattern Unstable angina Ejection fraction <40% and/or clinical evidence of heart failure Significant valvular heart disease Uncontrolled hypertension (>180/110 mmHg)
Facility Information:
Facility Name
Cardiovascular Prevention and Rehabilitation Centre of the Montreal Heart Institute
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T1N6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Sauna Bathing to Improve Vascular Health of Adults With Heart Disease

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