Sauna Bathing to Improve Vascular Health of Adults With Heart Disease

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Other: Lifestyle intervention

• Registration Number: NCT03620539
• Lead Sponsor: Montreal Heart Institute

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.

Study Timeline

• Study First Submitted: 2018-07-24
• Study First Submitted QC: 2018-08-03
• Study First Posted: 2018-08-08
• Study Start: 2018-12-04
• Primary Completion: 2022-09-12
• Study Completion: 2022-09-12
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Flow-mediated dilation	Change from baseline after 8 weeks	Brachial artery flow-mediated dilation in response to 5 minutes of forearm occlusion

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cardiovascular Prevention and Rehabilitation Centre of the Montreal Heart Institute; 🇨🇦 Montréal, Quebec, Canada