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Official title Passive Heat Therapy for Lowering Systolic Blood Pressure and Improving Vascular Function in Mid-life and Older Adults
ClinicalTrials.gov ID: NCT05300971
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- Individuals taking 3+ anti-hypertensive medications (rationale: these individuals typically have resistant or secondary hypertension. Individuals...
- SBP 140-159 mmHg but not on anti-hypertensive medications. (rationale: ACC/AHA guidelines indicate that immediate pharmacotherapy is advised for...
- Regular vigorous aerobic/endurance exercise: \>4 bouts per week for \>30 min per bout at a workload of \>10 METS, determined based on screening...
- Body mass index (BMI) \>40 kg/m2 (rationale: BP and vascular measurements can be inaccurate in severely obese people and these people may differ in...
- Current use of anticholinergics (e.g. amitriptyline), alpha-blockers (e.g. Flomax), and beta-blockers (e.g., propranolol) (rationale: these...
- Current use of certain prescription medications taken at a dose or frequency high enough to potentially interfere with thermoregulation and/or blood...
See the full eligibility criteria
Who can 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...
- 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...
- 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).
What rules you out
- 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...
- SBP 140-159 mmHg but not on anti-hypertensive medications. (rationale: ACC/AHA guidelines indicate that immediate pharmacotherapy is advised for these individuals. Potential people with SBP in this range will discuss...
- 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...
- Body mass index (BMI) \>40 kg/m2 (rationale: BP and vascular measurements can be inaccurate in severely obese people and these people may differ in many ways from normal weight, overweight, or less obese people).
- 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...
- 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...
- 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...
- 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...
- 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 people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Boulder, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boulder, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.