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Completed

NCT Number: NCT03620539

Sauna Bathing to Improve Vascular Health of 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.

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Key information

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiovascular Prevention and Rehabilitation Centre of the Montreal Heart Institute

Montreal, Quebec, H1T1N6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

lifestyle intervention

Other

Sauna bathing

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 8, 2018
Registry last updated
Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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