Cardiovascular DiseasesCHTNCT02518399
Chronic Heat Therapy for Improving Vascular Health
A study testing Heat therapy and Thermoneutral water immersion in people with Cardiovascular Diseases, run by University of Oregon at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Heat therapy and Thermoneutral water immersion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to 30 Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young, healthy, able-bodied
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Heat Therapy for Improving Biomarkers of Vascular Health in Young, Healthy, Humans
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.
Read the detailed description
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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Heat therapy, Thermoneutral water immersion
- Keywords
- Blood vessels, Heat, Cardiovascular diseases
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Thermoneutral water immersion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Mean arterial blood pressure
Change in blood pressure measured using brachial oscillation following >20 min supine rest.
Measured: 8 weeks
Secondary outcomes (1)
Cutaneous nitric oxide-dependent dilation
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startApr 2013
- Primary completionSep 2015
- Study completion30 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher T Minson, PhD, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518399
- Sponsor's protocol ID
- 09272013.025
- Other IDs
- 14PRE20380300
- Acronym
- CHT
- Status last verified
- Oct 2017
- First submitted
- 23 Jul 2015
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27270841
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Heat Therapy for Improving Biomarkers of Vascular Health in Young, Healthy, Humans
- ClinicalTrials.gov ID
- NCT02518399
- Acronym / sponsor ID
- CHT / 09272013.025
- Conditions
- Cardiovascular Diseases
- Keywords
- Blood vessels, Heat, Cardiovascular diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- 30 Apr 2016 (actual)
- First posted
- 7 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heat therapy | Experimental | Other: Heat therapySubjects 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 | Sham comparator | Other: Thermoneutral water immersionSubjects 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Young, healthy, able-bodied
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heat therapySubjects 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 immersionSubjects 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 |
Primary outcome
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.
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.
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.
Mean arterial blood pressure
Time frame: 8 weeks
Change in blood pressure measured using brachial oscillation following >20 min supine rest.
1 secondary outcome
Cutaneous nitric oxide-dependent dilation
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Results publication: PubMed 27270841Brunt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heat therapy and Thermoneutral water immersion in people with Cardiovascular Diseases, run by University of Oregon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in flow-mediated dilation (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02518399, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.