Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06348225
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-03-28
Brief Title:
Post-exercise Hot Water Immersion to Improve Overnight Blood Pressure
Sponsor:
Providence College
Organization:
Providence College
Study Overview
Official Title:
Post-exercise Hot Water Immersion to Improve Blood Pressure Control
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ExHT
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
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 13 of US 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 42C and combined exercise hot water immersion 30 minutes treadmill walking followed by 45 minutes in a 42C 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
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 42C and combined exercise hot water immersion 30 minutes treadmill walking followed by 45 minutes in a 42C 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None