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临床试验/NCT02518399
NCT02518399已完成不适用

Chronic Heat Therapy for Improving Biomarkers of Vascular Health in Young, Healthy, Humans

University of Oregon2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Change in flow-mediated dilation

研究概览

简要总结

The purpose of the study is to investigate whether long-term heat therapy (i.e. 8 weeks of hot tub 4-5x per week) improves biomarkers of cardiovascular health in young, healthy, able-bodied individuals. Although exercise is a potent means of improving cardiovascular health, many patients are unable to exercise effectively, and thus there is high demand for novel therapies to better manage cardiovascular risk in these patients. If successful, this study will set the groundwork for heat therapy to be used as an alternative treatment in patients who have limited exercise capabilities for the prevention of cardiovascular disease.

详细描述

Exercise training is a potent means of improving cardiovascular (CV) risk; however, exercise is challenging for many patient populations. Passive heat therapy may provide a simple and effective alternative to exercise for improving CV health, and no one has yet studied the physiological benefits of chronic heat exposure in humans. Heat exposure induces the expression of heat shock proteins, which can have a multitude of beneficial effects on the CV system, many of which are common to exercise training. In particular, these benefits include upregulation of many cellular pathways associated with improved vascular function, a predominant contributor to CV health. The goal of the study is to determine the effects of chronic passive heat therapy on vascular function in young, healthy, able-bodied individuals. The investigators will perform a randomized-controlled trial in which subjects participate in 8 weeks of either heat therapy or thermoneutral water immersion (sham). Heat therapy will entail 8 weeks of hot water immersion sufficient to raise core temperature >38.5°C for 1h, 4-5 times per week. Thermoneutral water immersion will entail 8 weeks of immersion in 36°C water for the same duration as heat therapy. In both subject groups, the investigators will measure various well-established biomarkers of vascular function before and after 8 weeks of heat therapy, including measures of arterial stiffness (arterial compliance, beta-stiffness, and pulse wave velocity), endothelium-dependent dilation (flow-mediated dilation), and intima media thickness. The investigators will investigate the effects of heat therapy on the microvasculature and on the mechanisms behind improvements in vascular function in the cutaneous microcirculation, an ideal site for pharmacodissecting the molecular pathways involved, using microdialysis paired with laser-Doppler flowmetry. If successful, these studies will serve as a basis for developing heat therapy as a novel means of improving CV risk, which has the potential to reshape the treatment of patient populations with limited exercise capabilities.

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
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Young, healthy, able-bodied

排除标准

  • Diagnosis of any chronic diseases related to the cardiovascular system (e.g. hypertension, cardiovascular disease, diabetes, etc.),
  • Currently taking prescription medications (except contraceptives)
  • Body mass index over 27 kg/m2
  • Current smoking
  • Currently pregnant or breast-feeding

研究组 & 干预措施

Heat therapy

Experimental

Subjects will report to the laboratory 4-5x per week for 8 weeks (36 sessions total) for heat therapy sessions. In each session, subjects will be immersed in a 40°C hot tub for up to 90min in order to increase body core temperature to 38.5°C and, once there, maintain it between 38.5-39.0°C for 60min.

干预措施: Heat therapy (Other)

Thermoneutral water immersion

Sham Comparator

Subjects will report to the laboratory 4-5x per week for 8 weeks (36 sessions total) for thermoneutral water immersion sessions. In each session, subjects will be immersed in a 36°C tub for 90min in order to maintain body core temperature at a constant level.

干预措施: Thermoneutral water immersion (Other)

结局指标

主要结局

Change in flow-mediated dilation

时间窗: 8 weeks

The change in percent dilation of the brachial artery following release of a 5-min arterial occlusion, measured using ultrasonography. This test is highly prognostic of cardiovascular risk and mortality.

Femoral dynamic arterial compliance

时间窗: 8 weeks

The change in compliance of the superficial femoral artery relative to blood pressure, measured using ultrasonography-tonometry. This is a measure of arterial stiffness.

Intima media thickness

时间窗: 8 weeks

Change in wall thickness of the common carotid artery, measured using ultrasonography. This is predictive of future development of cardiovascular disease, in particular, atherosclerosis.

Mean arterial blood pressure

时间窗: 8 weeks

Change in blood pressure measured using brachial oscillation following \>20 min supine rest.

次要结局

  • Cutaneous nitric oxide-dependent dilation(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher T Minson, PhD

Professor

University of Oregon

研究点 (2)

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