Clinical trial NCT03620539: 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
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: flow-mediated dilation
sauna
vascular
heat
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 61
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Flow-mediated dilation
timeFrame: Change from baseline after 8 weeks
Secondary outcomes:
measure: Post-occlusion reactive hyperaemia (AUC)
timeFrame: Change from baseline after 8 weeks
measure: Post-occlusion reactive hyperaemia (Peak)
timeFrame: Change from baseline after 8 weeks
measure: Local skin heating-induced vasodilation
timeFrame: Change from baseline after 8 weeks
Other outcomes:
measure: Blood pressure
timeFrame: Change from baseline after 8 weeks
measure: Central arterial stiffness
timeFrame: Change from baseline after 8 weeks
measure: Heart rate variability
timeFrame: Change from baseline after 8 weeks
Locations:
city: Montréal
country: Canada
facility: Cardiovascular Prevention and Rehabilitation Centre of the Montreal Heart Institute
state: Quebec
Study officials:
References:
citation: 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.