NCT02518399

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2016

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

2.4 years

First QC Date

July 23, 2015

Last Update Submit

October 24, 2017

Conditions

Cardiovascular Diseases

Keywords

Blood vesselsHeatCardiovascular diseases

Outcome Measures

Primary Outcomes (4)

  • Change in flow-mediated dilation

    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.

    8 weeks

  • Femoral dynamic arterial compliance

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

    8 weeks

  • Intima media thickness

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

    8 weeks

  • Mean arterial blood pressure

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

    8 weeks

Secondary Outcomes (1)

  • Cutaneous nitric oxide-dependent dilation

    8 weeks

Other Outcomes (1)

  • Carotid dynamic arterial compliance

    8 weeks

Study Arms (2)

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.

Other: Heat therapy

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.

Other: Thermoneutral water immersion

Interventions

Heat therapyOTHER

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.

Heat therapy
Thermoneutral water immersionOTHER

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.

Thermoneutral water immersion

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Young, healthy, able-bodied

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oregon

Eugene, Oregon, 97403, United States

Location

Related Publications (1)

  • Brunt VE, Howard MJ, Francisco MA, Ely BR, Minson CT. Passive heat therapy improves endothelial function, arterial stiffness and blood pressure in sedentary humans. J Physiol. 2016 Sep 15;594(18):5329-42. doi: 10.1113/JP272453. Epub 2016 Jun 30.

    PMID: 27270841RESULT

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Diathermy

Intervention Hierarchy (Ancestors)

Hyperthermia, InducedTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 23, 2015

First Posted

August 7, 2015

Study Start

April 1, 2013

Primary Completion

September 1, 2015

Study Completion

April 30, 2016

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations

US(1)