Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06348225 |
| Other study ID # |
FY24-10 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| 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 |
| Health authority |
|
| 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.
Read more »
