What is the mechanism of action of this treatment?

Common treatments for aging, such as heat therapy, work primarily through mechanisms like heat-induced vasodilation and improved vascular function. These treatments enhance blood flow, reduce arterial stiffness, and lower blood pressure, which are crucial for maintaining cardiovascular health. For aging patients, these benefits are significant as they help mitigate the risk of cardiovascular diseases, improve overall vascular health, and potentially enhance quality of life by reducing symptoms associated with poor circulation and high blood pressure.

What side effects are associated with this type of intervention?

Common treatments for aging that involve heat therapy, such as hot water immersion and sauna bathing, primarily aim to improve vascular function through heat-induced vasodilation. Known side effects of these treatments can include dehydration, hypotension, and potential cardiac arrhythmias, especially when combined with alcohol consumption. While generally safe for most healthy individuals and even those with stable cardiovascular disease, caution is advised. Adverse cardiac events, such as myocardial ischemia, have been reported in patients with coronary artery disease during sauna use. Therefore, it is important to use these therapies sensibly and under medical supervision, particularly for individuals with pre-existing cardiovascular conditions.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically targeting aging through mechanisms like heat-induced vasodilation and improved vascular function. However, treatments that improve vascular health, such as antihypertensive medications and lifestyle interventions like exercise, are commonly recommended to mitigate age-related vascular decline. These interventions aim to enhance vascular function and overall cardiovascular health, indirectly contributing to healthier aging.

What other types of research exist?

Promising novel alternatives to Hot Water Immersion (Heat Therapy) for aging patients include: 1) Topical nitroglycerin, which may improve vascular function by stimulating collagen synthesis and vasodilation. 2) Ultrasound-guided percutaneous needle tenotomy, which can enhance tissue healing and potentially improve vascular function. 3) Passive heat therapy using advanced technologies like infrared saunas, which can provide similar benefits of vasodilation and improved vascular function without the need for water immersion.

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Behavioural Intervention

Heat Therapy for High Blood Pressure

N/A

Recruiting

Led By Douglas R Seals, PhD

Research Sponsored by University of Colorado, Boulder

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Premenopausal women must not be pregnant (confirmed by urine pregnancy test)

Aged 50+ years

Must not have

Any rectal, anal, vaginal, or prostate surgery within the last 3 months, current or recent (within the last 3 months) hemorrhoids, or related concerns regarding use of rectal thermistor

Unstable cardiovascular diseases (e.g., unstable angina or recent myocardial infarction or stroke) (rationale: heat therapy is contraindicated for individuals with unstable CVDs)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 7 months

Summary

This trial is testing if taking regular hot baths can improve blood pressure and blood vessel function in adults aged 50 and older. The idea is that hot water might help relax blood vessels and improve blood flow, which could lower blood pressure.

Who is the study for?

This trial is for adults aged 50 or older with systolic blood pressure between 120-159 mmHg. Participants must be mentally capable of consent, not pregnant, weight stable, and willing to maintain their lifestyle throughout the study. They should be healthy enough for heat exposure but can't join if they have unstable heart conditions, take multiple anti-hypertensive drugs (except one or two), do intense regular exercise, have recent major health changes including surgery or COVID-19.

What is being tested?

The study tests whether hot water immersion ('heat therapy') versus thermoneutral water immersion over approximately 12 weeks can lower blood pressure and improve vascular function in middle-aged and older adults.

What are the potential side effects?

Potential side effects may include discomfort from prolonged water immersion, skin sensitivity to pool chemicals, dehydration due to heat exposure, dizziness or fainting during temperature changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant, confirmed by a test.

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I am 50 years old or older.

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My weight has been stable, changing by no more than 2 kg in the last 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had rectal, anal, vaginal, or prostate surgery in the last 3 months.

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I do not have unstable heart conditions like recent heart attacks.

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I do not have a significant drop in blood pressure when standing up.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 7 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 7 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 7 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Secondary study objectives

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.

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.

Other study objectives

Change in carotid artery beta-stiffness index from baseline to 2, 4, 6, 8, 10, and 12 weeks of heat therapy, and 4 and 12 weeks of follow-up.

Change in carotid-femoral pulse wave velocity from baseline to 2, 4, 6, 8, 10, and 12 weeks of heat therapy, and 4 and 12 weeks of follow-up.

Induced Hyperthermia

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Heat therapyExperimental Treatment1 Intervention

Hot water immersion \~3x per week for 12 weeks

Group II: Thermoneutral water immersionPlacebo Group1 Intervention

Thermoneutral water immersion \~3x per week for 12 weeks

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for aging, such as heat therapy, work primarily through mechanisms like heat-induced vasodilation and improved vascular function. These treatments enhance blood flow, reduce arterial stiffness, and lower blood pressure, which are crucial for maintaining cardiovascular health. For aging patients, these benefits are significant as they help mitigate the risk of cardiovascular diseases, improve overall vascular health, and potentially enhance quality of life by reducing symptoms associated with poor circulation and high blood pressure.

Acute Vascular Benefits of Finnish Sauna Bathing in Patients With Stable Coronary Artery Disease.Acute effect of Finnish sauna bathing on brachial artery flow-mediated dilation and reactive hyperemia in healthy middle-aged and older adults.Effects of heat and cold on health, with special reference to Finnish sauna bathing.