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Sauna Bathing to Improve Vascular Health of Adults With Heart Disease

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ClinicalTrials.gov Identifier: NCT03620539
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : May 12, 2021
Sponsor:
Information provided by (Responsible Party):
Daniel Gagnon, Montreal Heart Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Other: Lifestyle intervention Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Sauna Bathing on Cerebrovascular Function in Middle-aged to Older Adults With Heart Disease
Actual Study Start Date : December 4, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Flow-mediated dilation [ Time Frame: Change from baseline after 8 weeks ]
    Brachial artery flow-mediated dilation in response to 5 minutes of forearm occlusion


Secondary Outcome Measures :
  1. Post-occlusion reactive hyperaemia (AUC) [ Time Frame: Change from baseline after 8 weeks ]
    Vascular conductance area-under-the-curve during reactive hyperaemia induced by 5 minutes of forearm occlusion

  2. Post-occlusion reactive hyperaemia (Peak) [ Time Frame: Change from baseline after 8 weeks ]
    Peak vascular conductance during reactive hyperaemia induced by 5 minutes of forearm occlusion

  3. Local skin heating-induced vasodilation [ Time Frame: Change from baseline after 8 weeks ]
    Plateau of the cutaneous vascular conductance response during local heating of the skin to 39°C


Other Outcome Measures:
  1. Blood pressure [ Time Frame: Change from baseline after 8 weeks ]
    Systolic blood pressure at rest

  2. Central arterial stiffness [ Time Frame: Change from baseline after 8 weeks ]
    Carotid-femoral pulse wave velocity

  3. Heart rate variability [ Time Frame: Change from baseline after 8 weeks ]
    Resting levels of heart rate variability


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03620539


Contacts
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Contact: Daniel Gagnon 1-514-374-1480 ext 4205 daniel.gagnon.3@umontreal.ca
Contact: Hugo Gravel 1-514-374-1480 ext 4342 hugo.gravel@umontreal.ca

Locations
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Canada, Quebec
Cardiovascular Prevention and Rehabilitation Centre of the Montreal Heart Institute Recruiting
Montréal, Quebec, Canada, H1T1N6
Contact: Daniel Gagnon, PhD    514-374-1480 ext 4205    daniel.gagnon.3@umontreal.ca   
Sponsors and Collaborators
Montreal Heart Institute
More Information
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Responsible Party: Daniel Gagnon, Researcher, Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT03620539    
Other Study ID Numbers: ICM2017-2312
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: May 12, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniel Gagnon, Montreal Heart Institute:
flow-mediated dilation
sauna
vascular
heat
Additional relevant MeSH terms:
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Coronary Artery Disease
Heart Diseases
Coronary Disease
Myocardial Ischemia
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases