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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
  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
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Penang Hospital, Malaysia:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: January 26, 2011
Last Updated: January 26, 2011
Health Authority: Malaysia: Ministry of Health

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

ClinicalTrials.gov processed this record on May 16, 2013