Treating Hypertension With Breath Control

Hypertension Clinical Trial

Official title:

A Randomized Controlled Trial to Treat Hypertension by Regularising and Slowing Breathing

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01285193
• Other study ID #: CT10-HPP-001
• Secondary ID: NMRR-10-686-6238
• Status: Not yet recruiting
• Phase: N/A
• First received: January 26, 2011
• Last updated: January 26, 2011
• Start date: June 2011
• Est. completion date: February 2012

Study information

• Verified date: January 2011
• Source: Penang Hospital, Malaysia
• Contact: Kum Keong Ng, MBBS
• Phone: 6042225761
• Email: ngkk[@]crc.gov.my
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Malaysia	Ng Kum Keong	Georgetown	Penang

Sponsors (2)

Lead Sponsor	Collaborator
Penang Hospital, Malaysia	Ministry of Health, Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (1)

Grossman E, Grossman A, Schein MH, Zimlichman R, Gavish B. Breathing-control lowers blood pressure. J Hum Hypertens. 2001 Apr;15(4):263-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diastolic blood pressure	Change in diastolic blood pressure from baseline to end value at 2 months.	2 months	No
Secondary	Systolic blood presure	Change in systolic blood pressure from baseline to end value at 2 months.	2 months	No