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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01285193
First Posted: January 27, 2011
Last Update Posted: January 27, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Health, Malaysia
Information provided by:
Penang Hospital, Malaysia
  Purpose
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
Hypertension Behavioral: Breath control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01285193


Contacts
Contact: Kum Keong Ng, MBBS 6042225761 ngkk@crc.gov.my

Locations
Malaysia
Ng Kum Keong Not yet recruiting
Georgetown, Penang, Malaysia, 10990
Principal Investigator: Kum Keong Ng, MBBS         
Sponsors and Collaborators
Penang Hospital, Malaysia
Ministry of Health, Malaysia
Investigators
Principal Investigator: Kum Keong Ng, MBBS Clinical Research Centre, Penang Hospital
  More Information

Publications:
Responsible Party: Ng Kum Keong, Clinical Research Centre, Penang Hospital
ClinicalTrials.gov Identifier: NCT01285193     History of Changes
Other Study ID Numbers: CT10-HPP-001
NMRR-10-686-6238 ( Other Identifier: Ministry of Health Malaysia )
First Submitted: January 26, 2011
First Posted: January 27, 2011
Last Update Posted: January 27, 2011
Last Verified: January 2011

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases