Post-exercise Hot Water Immersion to Improve Overnight Blood Pressure

Elevated Blood Pressure Clinical Trial

— ExHT  

Official title:

Post-exercise Hot Water Immersion to Improve Blood Pressure Control

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06348225
• Other study ID #: FY24-10
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Providence College
• Contact: Kris A Monahan, PhD
• Phone: 401.865.2554
• Email: kmonaha6[@]providence.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to test whether putting your legs in a hot bath after exercise improves blood pressure in people with higher blood pressure.

. The main questions it aims to answer are:

• Whether exercise alone, hot water leg bath alone, or both treatments together cause blood pressure to be lower during sleep.

• If there are any changes in heart rhythm or blood vessel health after exercise, hot water leg bath, or the two treatments together that relate to changes in blood pressure.

Participants will complete four different trials:

• 30 minutes of walking with a 45-minute lukewarm leg bath after

• 30 minutes of walking with a 45-minute hot leg bath after

• 45 minutes of a hot leg bath with no exercise

• A day with no exercise or leg bath Researchers will look at their heart rhythm, blood vessels, and blood pressure after each of these trials to see if there are differences, and if exercise and heat together can improve heart health more than exercise or heat alone.

Description:

In 2017, the American Heart Association updated standards for diagnosing hypertension, while emphasizing the need for lifestyle modification in the early stages of blood pressure elevation. Using these updated criteria, approximately 1/3 of U.S. adults have hypertension, but few are able to improve their blood pressure through diet and exercise and often progress to more severe disease states. Novel interventions to promote blood pressure reduction in mild hypertension are needed to attenuate or prevent this progression to more severe hypertension. Heat therapy, the repeated application of passive heat through hot water immersion, has gained recent attention for promising blood pressure reduction and improvement in cardiovascular health. Our preliminary work combining exercise and hot water leg immersion indicates improved overnight blood pressure in individuals with elevated blood pressure, but the magnitude and mechanisms of this improvement require further study.

It is unknown whether the decrease in blood pressure following post-exercise heat exposure results from changes in systemic regulation (autonomic nervous system function, measured through heart rate variability), local factors (improved blood vessel function, measured through flow-mediated dilation), or both. The goal of the proposed research is to examine the impact of exercise alone (30 minutes of treadmill walking), hot water immersion alone (45 minutes in a leg bath set to 42°C), and combined exercise + hot water immersion (30 minutes treadmill walking followed by 45 minutes in a 42°C leg bath) on nocturnal blood pressure, autonomic function, and blood vessel function in individuals with elevated blood pressure. This goal will be addressed with the following specific aims:

Aim 1. To examine the impact of exercise, hot water leg immersion, or combined exercise + hot water immersion on overnight blood pressure in individuals with elevated blood pressure. We hypothesize that the combination of exercise and hot water immersion will result in reduced systolic and diastolic blood pressure through 12 hours post-exercise as compared to baseline or either standalone treatment.

Aim 2. To examine changes in autonomic function, as measured by heart rate variability (HRV) following exercise, leg heating, or combined therapies. We hypothesize that combined exercise and hot water immersion will result in higher HRV (indicating improved autonomic balance) compared to baseline measures.

Aim 3. To examine changes in blood vessel (endothelial) function, measured using flow-mediated dilation, following exercise, leg heating, or combined therapies. We hypothesize that combined exercise and hot water immersion will result in a higher flow-mediated dilation (indicating improved blood vessel relaxation) compared to baseline or either standalone intervention.

The results of this study have important health implications in the treatment of hypertension using lifestyle interventions for the millions of Americans with elevated blood pressure or hypertension. The findings have the potential to improve non-pharmacological treatment of hypertension by developing an exercise and heat exposure protocol that is cost-effective, easily implemented, and results in substantially reduced blood pressure and improved cardiovascular risk profile.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• resting blood pressure >120/80 mmHg; measured at screening visit

• BMI between 18-39.9

• capable of walking 30 min at a moderate intensity on a treadmill

Exclusion Criteria:

• diagnosed hypertension

• taking antihypertensive medications

• history of heat injury or heat illness

Related Conditions & MeSH terms

• Elevated Blood Pressure
• Hypertension

Intervention

Other:
• Exercise or heat treatment
Interventions will be each of the four arms described previously, administered ~1 week apart in a randomized, counter-balanced fashion.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Providence College

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambulatory blood pressure	Welch-Allyn ambulatory blood pressure monitor placed on the arm after treatment	24 hours post-treatment
Primary	Heart Rate Variability	3-lead ECG with paced breathing measured post-treatment	30-60 min post-treatment
Primary	Flow-mediated dilation	Measure of endothelial function in the brachial artery (arm), change in blood vessel diameter following a 5-minute blood flow occlusion and release	30-60 min post-treatment