Clinical trial NCT06348225: Post-exercise Hot Water Immersion to Improve Overnight Blood Pressure
Official title: Post-exercise Hot Water Immersion to Improve Blood Pressure Control
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Elevated Blood Pressure
Keywords: exercise, heat therapy
Lead sponsor: Providence College
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A repeated-measures design will be used with all participants completing the three acute interventions (exercise, heat, or exercise + heat) as well as a control day.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Ambulatory blood pressure
timeFrame: 24 hours post-treatment
measure: Heart Rate Variability
timeFrame: 30-60 min post-treatment
measure: Flow-mediated dilation
timeFrame: 30-60 min post-treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Providence College
name: Brett R Ely, PhD
role: PRINCIPAL_INVESTIGATOR
References: