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临床试验/NCT03626363
NCT03626363已完成不适用

Randomized, Active-Control Study to Determine the Effect of Mindfulness-Based Stress Reduction on Sympathetic Activity and Arterial Stiffness

Michigan Technological University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2018年9月4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
入组人数
52
试验地点
1
主要终点
Muscle Sympathetic Nerve Activity

研究概览

简要总结

This study evaluates the impact of mindfulness-based stress reduction (MBSR) on sympathetic nerve activity and arterial stiffness. The investigator's central hypothesis is that MBSR will reduce sympathetic activity and arterial stiffness.

详细描述

This study will recruit male and female subjects with elevated blood pressure who will participate in a randomized, active control study to examine the impact of mindfulness-based stress reduction (MBSR) on blood pressure, muscle sympathetic nerve activity and arterial stiffness. The study will utilize established techniques for assessing blood pressure patterns (24-hour ambulatory monitoring), peripheral sympathetic activity (microneurography) and vascular stiffness (applanation tonometry) in humans. This study includes a stress management education class for the active control.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Seated systolic blood pressure >119 mmHg and/or diastolic blood pressure >79 mmHg
  • •Body mass index <30 kg/m2

排除标准

  • •Pregnant women
  • •History of autonomic dysfunction
  • •Cardiovascular medication

研究组 & 干预措施

Mindfulness-Based Stress Reduction

Experimental

An 8-week program specifically designed to improve mindfulness and to reduce stress.

干预措施: Stress Management (Behavioral)

Stress Management Education

Active Comparator

An 8-week program specifically designed to provide education about stress responses in humans, and as an active control for Mindfulness-Based Stress Reduction studies.

干预措施: Stress Management (Behavioral)

结局指标

主要结局

Muscle Sympathetic Nerve Activity

时间窗: Data reported is the change in the mean value from before to after the 8 week intervention (i.e. pre to post).

Direct recordings of muscle sympathetic nerve activity from the peroneal nerve using microneurography. Sympathetic bursts that were at least three times higher than baseline noise were evaluated by a trained investigator and quantified as bursts per minute. The investigator was blinded to the condition and whether the data was pre or post until after all data was collected and analyzed.

次要结局

  • Arterial Stiffness(Data reported is the change in the mean value from before to after the 8 week intervention (i.e. pre to post).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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