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临床试验/CTRI/2018/08/015215
CTRI/2018/08/015215已完成1/2 期

Effect of Bhramari Pranayama on Cardiovascular Functions and Heart Rate Variability in Patients with Hypertension

NA1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年3月9日最近更新:
适应症

试验速览

阶段
1/2 期
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Blood pressure

研究概览

简要总结

·   This is a parallel group randomized control study designed to study the effect of Bhramari pranayama on cardiovascular function and heart rate variability in patients with hypertension.

Based on the inclusion and exclusion criteria, the patients will be randomized to either study group or control group.

Intervention:

Study Group: Subjects will be asked to perform Bhramari pranayama by inhaling through both nostrils and while exhaling should produce the sound of humming bee for the duration of 5 minutes in one day only.

Control group: Subjects will be asked to sit in a comfortable posture and to inhale deeply and then while exhaling should produce the sound of ‘SSSS’ for the duration of 5 minutes in one day only.

Assessment:

After collecting the demographic details, the following outcome measures will be assessed before, during and immediately after the intervention.

Cardiovascular Functions:

The cardiovascular variables such as systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), stoke volume (SV), cardiac output (CO), arterial stiffness and total peripheral resistant (TPR) will be assessed in sitting position using non-invasive blood pressure monitoring system (Ambulatory Blood Pressure Systems, Germany). A Non-invasive blood pressure cuff will be placed on the upper arm of the left hand at the level of the heart and the marker on the cuff will be directly above the brachial artery. The hand will be placed at the knee and flexed at the elbow.

Heart rate variability:

Heart rate variability will be derived from electrocardiogram taken using Holter monitoring system.

Follow up: Since this is study is designed to study the immediate effect, the subjects will not be followed up.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
30.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Subject with the history of essential hypertension 2) SBP < 180 mmHg & DBP < 110 mmHg 3) Using < 2 Anti-hypertensive medications 4) Willingness to participate in the study.

排除标准

  • Subject with the history of secondary hypertension and other cardiovascular diseases like coronary artery disease, heart failure, arrhythmia, rheumatic heart diseases and congenital heart diseases.
  • Subject who is unable to perform Bhramari pranayama.
  • Subjects with irregular and frequent change of hypertensive medications.

结局指标

主要结局

Blood pressure

时间窗: Baseline (5 minutes before intervention), during (intervention period) and immediately after intervention (for the period of 5 minutes)

次要结局

  • heart rate, Heart rate variability, stoke volume, cardiac output, arterial stiffness and total peripheral resistant(Baseline (5 minutes before intervention), during intervention (5 minutes) and immediately after intervention (for 5 minutes))

研究者

发起方
NA
申办方类型
Other [na]

研究点 (1)

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