Treating Hypertension With Breath Control

Not Applicable

• Conditions: Hypertension
• Interventions: Behavioral: Breath control

• Registration Number: NCT01285193
• Lead Sponsor: Penang Hospital, Malaysia

Brief Summary

The purpose of this study is to determine if blood pressure can be reduced in hypertensive subjects by regularising and slowing their breathing. This may be a safe and affordable complementary treatment for hypertension.

Detailed Description

This is a randomised controlled trial in which hypertensive subjects allocated to receive either a CD with relaxation music or one with the same music plus certain sound cues to guide the listener on when to breathe. The subjects will continue with their normal medications and the intervention will last 2 months.

Study Timeline

• Status Verified: 2011-01
• Study First Submitted: 2011-01-26
• Study First Submitted QC: 2011-01-26
• Last Update Submitted: 2011-01-26
• Study First Posted: 2011-01-27
• Last Update Posted: 2011-01-27
• Study Start: 2011-06
• Primary Completion: 2012-02
• Study Completion: 2012-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Above 18 years old
• Patients with essential hypertension
• Systolic BP from 140 to 159 mm Hg
• Diastolic BP from 90 to 99 mm Hg
• On hypertensive medication for at least 3 months before the study
• Hypertensive medication unchanged during the 3 months before the study
• Patients able to fill in a log sheet

Exclusion Criteria

• ischaemic heart disease
• congestive heart failure
• cardiac arrhythmias
• renal failure
• diabetes mellitus
• previous stroke
• major organ failure
• cigarette smoking
• respiratory diseases
• psychiatric disorders
• severe obesity (BMI >35 kg/m2)
• hearing impairment
• unable to operate a CD player or do not have access to a CD player
• arm circumference <22 cm. or >42 cm.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breath control	Breath control	A music CD with sound cues is used to guide the subject to breathe in a regular and slower rate. This is practiced for at least 15 minutes a day over 2 months.

Primary Outcome Measures

Name	Time	Method
Diastolic blood pressure	2 months	Change in diastolic blood pressure from baseline to end value at 2 months.

Secondary Outcome Measures

Name	Time	Method
Systolic blood presure	2 months	Change in systolic blood pressure from baseline to end value at 2 months.

Trial Locations

Locations (1)

Ng Kum Keong; 🇲🇾 Georgetown, Penang, Malaysia