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The goal of this clinical trial is to test whether putting a participant's legs in a hot bath after exercise improves blood pressure in people with higher blood pressure.
. The main questions it aims to answer are:
Participants will complete four different trials:
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 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. 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. The researchers 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. The researchers 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. The researchers 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise + Heat Therapy | Experimental | This treatment will include exercise (treadmill walking) and hot leg bath. |
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| Heat Therapy | Experimental | This treatment will only include the hot leg bath (no exercise). |
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| Exercise | Active Comparator | This treatment will include exercise (treadmill walking) followed by a sham leg bath. |
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| Control | No Intervention | Participants will refrain from exercise or heat exposure for at least 24 hours, and perform all study analyses for a control comparison. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | Participants will walk on a treadmill for 30 minutes at 55-60% of heart rate reserve. The treadmill will be set at 2mph and 2% grade, then be adjusted in the first 5 minutes to achieve target heart rate. |
| Measure | Description | Time Frame |
|---|---|---|
| Ambulatory blood pressure | Welch-Allyn ambulatory blood pressure monitor placed on the arm after treatment | 24 hours post-treatment |
| Heart Rate Variability | 3-lead ECG with paced breathing measured post-treatment | 30-60 min post-treatment |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brett R Ely, PhD | Providence College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence College | Providence | Rhode Island | 02918 | United States |
The current plan is to share only compiled data with other researchers if requested.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 28, 2024 | Mar 28, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 28, 2024 | Mar 28, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D009043 | Motor Activity |
| D000084462 | Hyperthermia |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
| D001832 | Body Temperature Changes |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D003972 | Diathermy |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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.
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It is not possible to mask the participant to treatments (exercise/no exercise, water temperature, etc) or the PI who is monitoring them during treatment. However, all data (hourly blood pressure, heart rate variability, and flow-mediated dilation) will be analyzed by an individual blinded to the trial/intervention.
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| Heat Therapy | Other | Participants will place their legs in a deep leg bath (mid-calf) set to 42C for 45 minutes. |
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| Sham leg bath | Other | Participants will place their legs in a deep leg bath (mid-calf) set to 36C for 45 minutes. |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |