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Treating Hypertension With Breath Control

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by Penang Hospital, Malaysia.
Recruitment status was:  Not yet recruiting
Ministry of Health, Malaysia
Information provided by:
Penang Hospital, Malaysia Identifier:
First received: January 26, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
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.

Condition Intervention
Behavioral: Breath control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial to Treat Hypertension by Regularising and Slowing Breathing

Further study details as provided by Penang Hospital, Malaysia:

Primary Outcome Measures:
  • Diastolic blood pressure [ Time Frame: 2 months ]
    Change in diastolic blood pressure from baseline to end value at 2 months.

Secondary Outcome Measures:
  • Systolic blood presure [ Time Frame: 2 months ]
    Change in systolic blood pressure from baseline to end value at 2 months.

Estimated Enrollment: 84
Study Start Date: June 2011
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Other Names:
  • breathing exercise
  • slow breathing

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.

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01285193

Ng Kum Keong
Georgetown, Penang, Malaysia, 10990
Sponsors and Collaborators
Penang Hospital, Malaysia
Ministry of Health, Malaysia
Principal Investigator: Kum Keong Ng, MBBS Clinical Research Centre, Penang Hospital
  More Information

Responsible Party: Ng Kum Keong, Clinical Research Centre, Penang Hospital Identifier: NCT01285193     History of Changes
Other Study ID Numbers: CT10-HPP-001  NMRR-10-686-6238 
Study First Received: January 26, 2011
Last Updated: January 26, 2011

Keywords provided by Penang Hospital, Malaysia:
high blood pressure
breath control
breathing exercise
audio CD

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases processed this record on February 20, 2017