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Completed

NCT Number: NCT02518399

Chronic Heat Therapy for Improving Vascular Health

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oregon

Eugene, Oregon, 97403, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Young, healthy, able-bodied

Exclusion criteria

  • 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

Treatment and study plan

heat therapy

Other

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.

Thermoneutral water immersion

Other

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.

Primary outcomes

  1. Change in flow-mediated dilation

    Time frame: 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.

  2. Femoral dynamic arterial compliance

    Time frame: 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.

  3. Intima media thickness

    Time frame: 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.

  4. Mean arterial blood pressure

    Time frame: 8 weeks

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

Secondary outcomes

  1. Cutaneous nitric oxide-dependent dilation

    Time frame: 8 weeks

    Change in the difference between cutaneous microdialysis sites receiving a nitric oxide inhibitor (L-NNA, IND # 124,303) and Lactated Ringer's (control). Measured using laser-Doppler flowmetry during a local heating protocol.

Other outcomes

  1. Carotid dynamic arterial compliance

    Time frame: 8 weeks

    Change in compliance of the common carotid artery relative to blood pressure, measured using ultrasonography-tonometry. This is a measure of arterial stiffness.

Sponsors and collaborators

Lead sponsor

University of Oregon

Other

Registry information

Official study title

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

Acronym: CHT

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Aug 7, 2015
Registry last updated
Oct 26, 2017

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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