AgingNCT05300971
Passive Heat Therapy for Lowering Systolic Blood Pressure and Improving Vascular Function in Mid-life and Older Adults
A study testing Heat therapy and Thermoneutral water immersion in people with Aging, run by University of Colorado, Boulder at 1 site in United States.
Trial summary
This study aims to determine the effects of ~12 weeks of repeated hot water immersion ("heat therapy") vs. thermoneutral water immersion on blood pressure and vascular function in late middle-life to older (≥40 years) adults. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- 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
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to provide informed consent (no clinical diagnosis of dementia or related diseases AND mini mental state exam score >20).
- Willing to accept random assignment to intervention.
- Aged 40+ years.
- Premenopausal women must not be pregnant (confirmed by urine pregnancy test).
- Casual systolic blood pressure 115-159 mmHg.
- Sufficiently healthy to undergo heat stress, as determined by the CTRC physician Dr. Wolfe and physician of record Dr. Chonchol based on medical history, physical exam, blood chemistries, and 12-lead ECG at rest and during the graded exercise test. Subjects with established clinical diseases may participate so long it is not determined that heat therapy could be detrimental to their health (determined case-by-case, but examples of subjects who may be excluded include those currently undergoing chemotherapy treatment or chronic kidney disease patients requiring dialysis).
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- Ability to refrain from the use of dietary supplements, anti-inflammatory medications, and prescription medications prior to experimental testing and/or water immersion visits in some cases (occasionally used PDE5 inhibitors and nitrites) (for the durations described above), as determined by the CTRC physician and approved by the subject's primary care provider if deemed necessary (see Procedures below for more detail). (rationale: many of these agents can acutely modulate vascular function).
- Weight stable in the prior 3 months (≤ 2 kg weight change) and willing to remain weight stable over the course of the study.
- Willing to maintain physical activity, diet, and other lifestyle factors for the entire 6-month duration of the study.
- Free from alcohol dependence or abuse, as defined by the American Psychiatry Association, Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).
Who cannot join
- Individuals taking 3+ anti-hypertensive medications (rationale: these individuals typically have resistant or secondary hypertension. Individuals taking 1-2 anti-hypertensive medications will still be included, with the exception of beta-blockers.)
- SBP 140-159 mmHg but not on anti-hypertensive medications. (rationale: ACC/AHA guidelines indicate that immediate pharmacotherapy is advised for these individuals. Potential subjects with SBP in this range will discuss options/receive recommendations from a CTRC physician and be referred to their primary care provider. If they begin anti-hypertensive medication, they will be eligible to participate in the study after they have been on them for at least 3 months, assuming they still qualify. If they decide not to begin anti-hypertensive medications, they must receive approval for their primary care provider that it is ok for them to participate in the study.)
- Regular vigorous aerobic/endurance exercise: >4 bouts per week for >30 min per bout at a workload of >10 METS, determined based on screening surveys and workload confirmed by MAQ during Visit 1. (rationale: aerobic exercise training independently lowers blood pressure and improves arterial function33,74,75).
- Body mass index (BMI) >40 kg/m2 (rationale: BP and vascular measurements can be inaccurate in severely obese subjects and these subjects may differ in many ways from normal weight, overweight, or less obese subjects).
- Current use of anticholinergics (e.g. amitriptyline), alpha-blockers (e.g. Flomax), and beta-blockers (e.g., propranolol) (rationale: these medications can interfere with thermoregulation and/or control of blood pressure during heat stress). *Note: anti-hypertensive medications besides beta-blockers will be allowed-see "Additional considerations for subjects taking anti-hypertensive medications" below under the intervention procedures for Section XI.).
- Current use of certain prescription medications taken at a dose or frequency high enough to potentially interfere with thermoregulation and/or blood pressure control during heat stress. These include nitrates and nitrites (e.g. nitroglycerin), PDE5 inhibitors (e.g. Viagra), amphetamines (e.g., ADD/ADHD drugs), insulin, and thyroid medications. Risk of each of these classes of medications depends on dose and other medications also being taken. Thus, Drs. Wolfe and Chonchol will make decisions whether subjects taking these medications should be excluded. (Note: occasional use of PDE5 inhibitors and nitrates ok so long as they are not taken for the following durations around water immersion sessions, PDE5 inhibitors: 24 hours before through the 8 hours after; nitrates: 8 hours before through 8 hours after, and (for both classes of medications) in the 48 hours before through the 48 hours after visits in which nitroglycerin is administered [visits 3, 10, \& 13] - Drs. Wolfe and Chonchol can extend these durations as they deem necessary and will have the opportunity to do so during the medication review process at screening).
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- Orthostatic hypotension, as determined by medical history or during screening as a reduction of >20 mmHg on SBP and/or >10 mmHg in diastolic BP within 3 min of going from seated to standing (rationale: passive heat therapy is contraindicated for individuals with orthostatic hypotension).
- Active, untreated atrial fibrillation or flutter (rationale: it is possible individuals with atrial fibrillation/flutter may have a higher risk of arrhythmias during hot water immersion).
- Unstable cardiovascular diseases (e.g., unstable angina or recent myocardial infarction or stroke) (rationale: heat therapy is contraindicated for individuals with unstable CVDs).
- Recent major change in health status within previous 3 months (e.g., surgery, significant infection or illness, including COVID-19). What is considered "major" or "significant" may be evaluated by the physician of record on a case-by-case basis. An example of a surgery that would likely not be considered "major" is out-patient removal of a basal cell carcinoma. "Significant" infections include those requiring hospitalization or long durations (i.e., months) of recovery. Additionally, subjects with acute fever/illness (Tre ≥ 38.0°C) will not be able to undergo screening or participate in water immersion sessions until fever/illness has resolved. Subjects with a confirmed positive case of COVID-19 will not be able to participate until COVID-19 symptoms have resolved and 2 weeks after diagnosis. Subjects will be asked to let us know if they are sick so that sessions/testing can be rescheduled.
- Open wounds or skin lesions. History of skin-related conditions or sensitivities to prolonged water immersion or exposure to pool chemicals.
- Blood donation within the past 2 months (if subjects have donated blood within the last 2 months, we will ask if they are willing to delay the start of the study until it has been 2 months since their last blood donation)
- Inability to tolerate blood draws, intravenous catheters, including past fainting in response to blood sampling. (rationale: at the least, we must be able to obtain enough blood for clinical chemistries to ensure safety).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Boulder
Boulder, Colorado, 80309
Vienna E Brunt, PhD, 303-735-4554, vienna.brunt@colorado.edu
About this study
This study aims to determine the effects of ~12 weeks of repeated hot water immersion ("heat therapy") vs. thermoneutral water immersion on blood pressure and vascular function in late middle-life to older (≥40 years) adults. The study also aims to determine the effects of ~12 weeks of heat therapy on fluid cognitive and cerebrovascular function.
Read the detailed description
Advancing age is the primary risk factor for cardiovascular diseases (CVD), which remain the leading cause of death in the developed world. The key process that links aging to increased risk of CVD is increases in systolic blood pressure and the development of arterial dysfunction (i.e., impaired endothelial function and arterial stiffening).
Passive heat therapy, in the form of repeated use of hot baths and saunas, has been used by several cultures for centuries; however, the physiological benefits are only now being elucidated. For example, recent studies have found that lifelong habitual sauna use is associated with considerably reduced risk of all-cause mortality, sudden cardiac death, CVD-related death. In addition, 8-10 weeks of hot water immersion in young adults has been shown to improve endothelial function and reduces arterial stiffness and blood pressure. Therefore, the investigators expect heat therapy to similarly improve blood pressure and vascular function in middle-life and older adults who are at greater risk of CVD.
Aging is also the primary risk factor for Alzheimer's disease and related dementias, as well as mild cognitive impairment (MCI). Above-normal systolic blood pressure (SBP; ≥115 mmHg) further increases risk of dementias, due, in part, to SBP-associated cerebrovascular dysfunction, i.e., impaired cerebral blood flow regulation. Accordingly, midlife and older adults with above-normal SBP are at the highest risk for cognitive decline driven by vascular contributions to cognitive impairment and dementias in this age group. Excessive reactive oxygen species-induced oxidative stress and reductions in nitric oxide (NO) bioavailability within the cerebral vasculature likely mediate cerebrovascular dysfunction with aging and contribute to MCI and Alzheimer's disease and related dementias in those with above-normal SBP.
- Conditions
- Aging
- Being tested
- Heat therapy, Thermoneutral water immersion
- Keywords
- Endothelial function, Arterial stiffness, Heat, Hot water immersion, Systolic blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat therapyOther
36 sessions (~3x per week for 12 weeks) of hot water immersion in 40°C water, sufficient to raise body core temperature to 38.5°C, and 12 weeks of follow-up.
Thermoneutral water immersionOther
36 sessions (~3x per week for 12 weeks) of thermoneutral water immersion in 36°C water to prevent changes in body core temperature >0.2°C, and 12 weeks of follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Heat therapy | Experimental | Hot water immersion ~3x per week for 12 weeks Receives: Other: Heat therapy |
| Thermoneutral water immersion | Sham comparator | Thermoneutral water immersion ~3x per week for 12 weeks Receives: Other: Thermoneutral water immersion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in casual systolic blood pressure from baseline to 2, 4, 6, 8, 10, and 12 weeks of heat therapy, and 4 and 12 weeks of follow-up.
Casual brachial artery systolic blood pressure, measured in triplicate (and averaged)
Measured: 0 weeks, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 24 weeks
Secondary outcomes (2)
Change in 24-hour ambulatory systolic blood pressure from from baseline to 2, 4, 6, 8, 10, and 12 weeks of heat therapy, and 4 and 12 weeks of follow-up.
Brachial artery systolic blood pressure measured over 24 hours with an ambulatory monitor
Measured: 0 weeks, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 24 weeks
Change in brachial artery flow-mediated dilation from baseline to 2, 4, 6, 8, 10, and 12 weeks of heat therapy, and 4 and 12 weeks of follow-up.
Measure of endothelial function
Measured: 0 weeks, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start1 Aug 2022
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, sham controlled (parallel design), single-blind
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas Seals, University of Colorado, Boulder
- Investigators
- Douglas R Seals, PhD, Principal investigator, University of Colorado, BoulderVienna E Brunt, PhD, Principal investigator, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300971
- Sponsor's protocol ID
- 21-0433
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2021
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 27270841Oh ES, Opoku G, Darvish S, Craighead DH, Ostrow A, Rossman MJ, Steele CN, Struemph T, You Z, Seals DR, Chonchol M, Nowak KL. Sex Differences in Dementia and Mild Cognitive Impairment in Nondialysis CKD. Clin J Am Soc Nephrol. 2026 Mar 1;21(3):389-400. doi: 10.2215/CJN.0000000922. Epub 2025 Nov 20.
PubMed 41264372
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passive Heat Therapy for Lowering Systolic Blood Pressure and Improving Vascular Function in Mid-life and Older Adults
- ClinicalTrials.gov ID
- NCT05300971
- Acronym / sponsor ID
- 21-0433
- Conditions
- Aging
- Keywords
- Endothelial function, Arterial stiffness, Heat, Hot water immersion, Systolic blood pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 29 Mar 2022 (actual)
- 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.
This study aims to determine the effects of ~12 weeks of repeated hot water immersion ("heat therapy") vs. thermoneutral water immersion on blood pressure and vascular function in late middle-life to older (≥40 years) adults. The study also aims to determine the effects of ~12 weeks of heat therapy on fluid cognitive and cerebrovascular function.
Detailed description
Advancing age is the primary risk factor for cardiovascular diseases (CVD), which remain the leading cause of death in the developed world. The key process that links aging to increased risk of CVD is increases in systolic blood pressure and the development of arterial dysfunction (i.e., impaired endothelial function and arterial stiffening).
Passive heat therapy, in the form of repeated use of hot baths and saunas, has been used by several cultures for centuries; however, the physiological benefits are only now being elucidated. For example, recent studies have found that lifelong habitual sauna use is associated with considerably reduced risk of all-cause mortality, sudden cardiac death, CVD-related death. In addition, 8-10 weeks of hot water immersion in young adults has been shown to improve endothelial function and reduces arterial stiffness and blood pressure. Therefore, the investigators expect heat therapy to similarly improve blood pressure and vascular function in middle-life and older adults who are at greater risk of CVD.
Aging is also the primary risk factor for Alzheimer's disease and related dementias, as well as mild cognitive impairment (MCI). Above-normal systolic blood pressure (SBP; ≥115 mmHg) further increases risk of dementias, due, in part, to SBP-associated cerebrovascular dysfunction, i.e., impaired cerebral blood flow regulation. Accordingly, midlife and older adults with above-normal SBP are at the highest risk for cognitive decline driven by vascular contributions to cognitive impairment and dementias in this age group. Excessive reactive oxygen species-induced oxidative stress and reductions in nitric oxide (NO) bioavailability within the cerebral vasculature likely mediate cerebrovascular dysfunction with aging and contribute to MCI and Alzheimer's disease and related dementias in those with above-normal SBP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized, sham controlled (parallel design), single-blind
| Arm | Type | Receives |
|---|---|---|
| Heat therapy | Experimental | Other: Heat therapyHot water immersion ~3x per week for 12 weeks |
| Thermoneutral water immersion | Sham comparator | Other: Thermoneutral water immersionThermoneutral water immersion ~3x per week for 12 weeks |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Able to provide informed consent (no clinical diagnosis of dementia or related diseases AND mini mental state exam score >20).
- Willing to accept random assignment to intervention.
- Aged 40+ years.
- Premenopausal women must not be pregnant (confirmed by urine pregnancy test).
- Casual systolic blood pressure 115-159 mmHg.
Key exclusion criteria (13 listed)
- Individuals taking 3+ anti-hypertensive medications (rationale: these individuals typically have resistant or secondary hypertension. Individuals taking 1-2 anti-hypertensive medications will still be included, with the exception of beta-blockers.)
- SBP 140-159 mmHg but not on anti-hypertensive medications. (rationale: ACC/AHA guidelines indicate that immediate pharmacotherapy is advised for these individuals. Potential subjects with SBP in this range will discuss options/receive recommendations from a CTRC physician and be referred to their primary care provider. If they begin anti-hypertensive medication, they will be eligible to participate in the study after they have been on them for at least 3 months, assuming they still qualify. If they decide not to begin anti-hypertensive medications, they must receive approval for their primary care provider that it is ok for them to participate in the study.)
- Regular vigorous aerobic/endurance exercise: >4 bouts per week for >30 min per bout at a workload of >10 METS, determined based on screening surveys and workload confirmed by MAQ during Visit 1. (rationale: aerobic exercise training independently lowers blood pressure and improves arterial function33,74,75).
- Body mass index (BMI) >40 kg/m2 (rationale: BP and vascular measurements can be inaccurate in severely obese subjects and these subjects may differ in many ways from normal weight, overweight, or less obese subjects).
- Current use of anticholinergics (e.g. amitriptyline), alpha-blockers (e.g. Flomax), and beta-blockers (e.g., propranolol) (rationale: these medications can interfere with thermoregulation and/or control of blood pressure during heat stress). *Note: anti-hypertensive medications besides beta-blockers will be allowed-see "Additional considerations for subjects taking anti-hypertensive medications" below under the intervention procedures for Section XI.).
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 therapy36 sessions (~3x per week for 12 weeks) of hot water immersion in 40°C water, sufficient to raise body core temperature to 38.5°C, and 12 weeks of follow-up. | Other | Heat therapy |
| Thermoneutral water immersion36 sessions (~3x per week for 12 weeks) of thermoneutral water immersion in 36°C water to prevent changes in body core temperature >0.2°C, and 12 weeks of follow-up. | Other | Thermoneutral water immersion |
Primary outcome
Change in casual systolic blood pressure from baseline to 2, 4, 6, 8, 10, and 12 weeks of heat therapy, and 4 and 12 weeks of follow-up.
Time frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 24 weeks
Casual brachial artery systolic blood pressure, measured in triplicate (and averaged)
2 secondary outcomes
Change in 24-hour ambulatory systolic blood pressure from from baseline to 2, 4, 6, 8, 10, and 12 weeks of heat therapy, and 4 and 12 weeks of follow-up.
Time frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 24 weeks
Change in brachial artery flow-mediated dilation from baseline to 2, 4, 6, 8, 10, and 12 weeks of heat therapy, and 4 and 12 weeks of follow-up.
Time frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: 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.
- Derived from this study: PubMed 41264372Oh ES, Opoku G, Darvish S, Craighead DH, Ostrow A, Rossman MJ, Steele CN, Struemph T, You Z, Seals DR, Chonchol M, Nowak KL. Sex Differences in Dementia and Mild Cognitive Impairment in Nondialysis CKD. Clin J Am Soc Nephrol. 2026 Mar 1;21(3):389-400. doi: 10.2215/CJN.0000000922. Epub 2025 Nov 20.
- Individual participant dataSharing planned: No
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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.
Douglas R Seals, PhD principal investigator
University of Colorado, Boulder
Vienna E Brunt, PhD principal investigator
University of Colorado, Boulder
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 Aging, run by University of Colorado, Boulder 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 10 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vienna E Brunt, PhD (303-724-4898, vienna.brunt@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in casual systolic blood pressure from baseline to 2, 4, 6, 8, 10, and 12 weeks of heat therapy, and 4 and 12 weeks of follow-up. (time frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 24 weeks). 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 NCT05300971, which also lists 2 linked publications.
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 2 Nov 2026.