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临床试验/NCT03320577
NCT03320577已完成不适用

Take a Deep Breath: Randomized Controlled Trial of the Effects of Breathing Exercises on Blood Pressure

University of Missouri-Columbia2 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2016年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
103
试验地点
2
主要终点
Reduced blood pressure from breathing exercises

研究概览

简要总结

This study will compare participants who have uncontrolled hypertension and perform a set of five breathing exercises (Pranayama breathing) to a control group. The purpose of the study is to determine the effect of the breathing exercises on reduction of blood pressure.

详细描述

Untreated or uncontrolled hypertension is a leading cause of heart disease, stroke, and kidney failure. Hypertension, is a modifiable risk factor that may be successfully treated using one or a combination of treatment options, including medication, diet, exercise, tobacco cessation, or complementary and alternative medicine such as breathing exercises. A well-established cascade of adverse health outcomes are associated with hypertension as well as increased mortality rates. For patient-centered care, providing patients with additional strategies for their health care also has the potential to empower the patient, augment patient-physician team approach to the patient's health care, and support the standards of care for treating hypertension. As explained by McCaffrey et al from their focus group work with patients, "Participants do not want prescription medications except as a last resort and feel that conventional medicine overemphasizes prescription medicines. This may be because of a combination of factors including distrust in conventional medicine, fear of side effects from medicines, and an underlying belief that the body can heal itself given the right nutrition, rest, and time"

Using a randomized controlled trial study design with a 1-month and 3-month follow-up, the investigators hypothesize that practicing breathing at least 5 times per week will show a mean reduction in systolic (SBP) and diastolic (DBP) blood pressures in uncontrolled hypertensive patients compared to control patients. Participants will be randomized into one of three arms of the study. For the intervention arm, participants will be either assigned to a weekly class for the pranayama breathing instruction and practice or given a DVD that contains instructions on the breathing exercises and the 15-minute practice session.

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
None

入排标准

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

入选标准

  • 未提供

排除标准

  • comorbidities of COPD, renal disease or chronic alcoholism

结局指标

主要结局

Reduced blood pressure from breathing exercises

时间窗: Baseline to week 10

5 mmHg point reduction in blood pressure (dichotomous variable) associated with breathing exercises

次要结局

  • Beta blocker medication affect on blood pressure reduction(Baseline to week 6)
  • Depressive severity response to breathing exercises(Baseline to week 18)
  • Perceived political stress level of participant affect on blood pressure reduction(Baseline to week 10)
  • Self Efficacy response to breathing exercises(Baseline to week 18)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jane McElroy

Associate Professor

University of Missouri-Columbia

研究点 (2)

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