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临床试验/NCT06348225
NCT06348225已完成不适用

Post-exercise Hot Water Immersion to Improve Blood Pressure Control

Providence College2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Heart Rate Variability

研究概览

简要总结

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:

  • 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 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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • diagnosed hypertension
  • taking antihypertensive medications
  • history of heat injury or heat illness

研究组 & 干预措施

Heat Therapy

Experimental

This treatment will only include the hot leg bath (no exercise).

干预措施: Heat Therapy (Other)

Exercise + Heat Therapy

Experimental

This treatment will include exercise (treadmill walking) and hot leg bath.

干预措施: Exercise (Behavioral)

Exercise + Heat Therapy

Experimental

This treatment will include exercise (treadmill walking) and hot leg bath.

干预措施: Heat Therapy (Other)

Exercise

Active Comparator

This treatment will include exercise (treadmill walking) followed by a sham leg bath.

干预措施: Exercise (Behavioral)

Exercise

Active Comparator

This treatment will include exercise (treadmill walking) followed by a sham leg bath.

干预措施: Sham leg bath (Other)

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.

结局指标

主要结局

Heart Rate Variability

时间窗: 30-60 min post-treatment

3-lead ECG with paced breathing measured post-treatment

Ambulatory blood pressure

时间窗: 24 hours post-treatment

Welch-Allyn ambulatory blood pressure monitor placed on the arm after treatment

Flow-mediated dilation

时间窗: 30-60 min post-treatment

Measure of endothelial function in the brachial artery (arm), change in blood vessel diameter following a 5-minute blood flow occlusion and release

次要结局

未报告次要终点

研究者

发起方
Providence College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Brett Romano Ely

Assistant Professor of Health Sciences

Providence College

研究点 (2)

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