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临床试验/NCT00594048
NCT00594048已完成不适用

The Effects of Device-guided Breathing Exercises on Blood Pressure in Patients With Hypertension. A Randomized, Single-blind, Controlled Trial

Medical Research Foundation, The Netherlands1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Systolic Blood Pressure

研究概览

简要总结

The purpose of this study is to determine whether breathing-exercises with the Resperate or listening to a discman with freely chosen music are effective in the treatment of hypertension

详细描述

Hypertension is an important risk factor for the development of macrovascular events. Lowering blood pressure leads to a reduced risk of developing these complications. To treat hypertension effectively you can use blood pressure lowering drugs, but it is also important to use proven and safe non-pharmacological interventions. It is suggested that Breathing Rate and Systolic Blood Pressure can be linked directly together by the baroreflex. With the use of the Resperate, people will lower their breathing rate by breathing similar to music patterns which could theoretically lead, through the described link, to blood pressure reduction. Patients will be randomize into two groups: one will get a discman with freely chosen music and the other the Resperate. Patients are instructed to use the breathing device or discman for 15 minutes at about the same time every day during the 9 week study period, except for the first week.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • Over 18 years old
  • Known hypertension with a SBP between 130-170 mmHg at previous visit to the internal outpatient department and at the last visit to the internist
  • Treated with one or more anti-hypertensive drugs, which have not been changed for the preceding three months
  • At Baseline the SBP should be between 140-160 mmHg

排除标准

  • Patients with known diabetes
  • Patients with heart failure (NYHA III-IV)
  • Patients with pulmonary disease
  • Patients with insufficient knowledge of the Dutch language to understand the requirements of the study

结局指标

主要结局

Systolic Blood Pressure

时间窗: 9 weeks

次要结局

  • Quality of life(9 weeks)
  • Diastolic Blood Pressure(9 weeks)

研究者

发起方
Medical Research Foundation, The Netherlands
申办方类型
Other

研究点 (1)

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