Treating Hypertension With Breath Control

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Penang Hospital, Malaysia.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Ministry of Health, Malaysia
Information provided by:
Penang Hospital, Malaysia
ClinicalTrials.gov Identifier:
NCT01285193
First received: January 26, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted

January 26, 2011
January 26, 2011
June 2011
February 2012   (final data collection date for primary outcome measure)
Diastolic blood pressure [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Change in diastolic blood pressure from baseline to end value at 2 months.
Same as current
No Changes Posted
Systolic blood presure [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Change in systolic blood pressure from baseline to end value at 2 months.
Same as current
Not Provided
Not Provided
 
Treating Hypertension With Breath Control
A Randomized Controlled Trial to Treat Hypertension by Regularising and Slowing Breathing

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Hypertension
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
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.
Intervention: Behavioral: Breath control
Grossman E, Grossman A, Schein MH, Zimlichman R, Gavish B. Breathing-control lowers blood pressure. J Hum Hypertens. 2001 Apr;15(4):263-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
84
February 2012
February 2012   (final data collection date for primary outcome measure)

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.
Both
19 Years and older
No
Contact: Kum Keong Ng, MBBS 6042225761 ngkk@crc.gov.my
Malaysia
 
NCT01285193
CT10-HPP-001, NMRR-10-686-6238
No
Ng Kum Keong, Clinical Research Centre, Penang Hospital
Penang Hospital, Malaysia
Ministry of Health, Malaysia
Principal Investigator: Kum Keong Ng, MBBS Clinical Research Centre, Penang Hospital
Penang Hospital, Malaysia
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP