Sauna Bathing to Improve Vascular Health of Adults With Heart Disease

NCT03620539 | Completed

• 1 other identifier: ICM2017-2312
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

flow-mediated dilation; sauna; vascular; heat

Outcome Measures

Primary Outcomes (1)

• Flow-mediated dilation

  Brachial artery flow-mediated dilation in response to 5 minutes of forearm occlusion

  Change from baseline after 8 weeks

Secondary Outcomes (3)

• Post-occlusion reactive hyperaemia (AUC)

  Change from baseline after 8 weeks

• Post-occlusion reactive hyperaemia (Peak)

  Change from baseline after 8 weeks

• Local skin heating-induced vasodilation

  Change from baseline after 8 weeks

Other Outcomes (3)

• Blood pressure

  Change from baseline after 8 weeks

• Central arterial stiffness

  Change from baseline after 8 weeks

• Heart rate variability

  Change from baseline after 8 weeks

Study Arms (2)

Control

NO INTERVENTION

Participants randomized to the control condition will be asked to maintain their normal daily habits.

Sauna

EXPERIMENTAL

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

Interventions

Lifestyle intervention OTHER

Sauna bathing

Sauna

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Montreal Heart Institute: lead

Study Sites (1)

Cardiovascular Prevention and Rehabilitation Centre of the Montreal Heart Institute

Montreal, Quebec, H1T1N6, Canada

Location

Related Publications (1)

• 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.

  PMID: 37650138 RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 8, 2018
• Study Start: December 4, 2018
• Primary Completion: September 12, 2022
• Study Completion: September 12, 2022
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)