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临床试验/NCT03620539
NCT03620539已完成不适用

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

Montreal Heart Institute2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2018年12月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
61
试验地点
2
主要终点
Flow-mediated dilation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Flow-mediated dilation

时间窗: Change from baseline after 8 weeks

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

次要结局

  • 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)

研究者

发起方
Montreal Heart Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Gagnon

Researcher

Montreal Heart Institute

研究点 (2)

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