Sauna Bathing to Improve Vascular Health of Adults With Heart Disease

Effects of Sauna Bathing on Cerebrovascular Function in Middle-aged to Older Adults With Heart Disease

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Other: Lifestyle intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H1T1N6
      • Cardiovascular Prevention and Rehabilitation Centre of the Montreal Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Participants randomized to the control condition will be asked to maintain their normal daily habits.
Experimental: Sauna; The sauna intervention will consist of 20 to 30 minute sauna bathing sessions within a dry Finnish sauna, performed 4 times per week.	Other: Lifestyle intervention; Sauna bathing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flow-mediated dilation	Brachial artery flow-mediated dilation in response to 5 minutes of forearm occlusion	Change from baseline after 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-occlusion reactive hyperaemia (AUC)	Vascular conductance area-under-the-curve during reactive hyperaemia induced by 5 minutes of forearm occlusion	Change from baseline after 8 weeks
Post-occlusion reactive hyperaemia (Peak)	Peak vascular conductance during reactive hyperaemia induced by 5 minutes of forearm occlusion	Change from baseline after 8 weeks
Local skin heating-induced vasodilation	Plateau of the cutaneous vascular conductance response during local heating of the skin to 39°C	Change from baseline after 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Systolic blood pressure at rest	Change from baseline after 8 weeks
Central arterial stiffness	Carotid-femoral pulse wave velocity	Change from baseline after 8 weeks
Heart rate variability	Resting levels of heart rate variability	Change from baseline after 8 weeks

Collaborators and Investigators

• Sponsor: Montreal Heart Institute

Publications and helpful links

General Publications

• Debray A, Gravel H, Garceau L, Bartlett AA, Chaseling GK, Barry H, Behzadi P, Ravanelli N, Iglesies-Grau J, Nigam A, Juneau M, Gagnon D. Finnish sauna bathing and vascular health of adults with coronary artery disease: a randomized controlled trial. J Appl Physiol (1985). 2023 Oct 1;135(4):795-804. doi: 10.1152/japplphysiol.00322.2023. Epub 2023 Aug 31.

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2018
• Primary Completion (Actual): September 12, 2022
• Study Completion (Actual): September 12, 2022

Study Registration Dates

• First Submitted: July 24, 2018
• First Submitted That Met QC Criteria: August 3, 2018
• First Posted (Actual): August 8, 2018

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: heat; flow-mediated dilation; sauna; vascular
• Additional Relevant MeSH Terms: Myocardial Ischemia; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease
• Other Study ID Numbers: ICM2017-2312

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No