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Treating Hypertension With Breath Control

Primary Purpose

Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Breath control
Sponsored by
Penang Hospital, Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring hypertension, high blood pressure, treatment, breath control, breathing exercise, audio CD

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ng Kum Keong

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Breath control

Arm Description

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.

Outcomes

Primary Outcome Measures

Diastolic blood pressure
Change in diastolic blood pressure from baseline to end value at 2 months.

Secondary Outcome Measures

Systolic blood presure
Change in systolic blood pressure from baseline to end value at 2 months.

Full Information

First Posted
January 26, 2011
Last Updated
January 26, 2011
Sponsor
Penang Hospital, Malaysia
Collaborators
Ministry of Health, Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT01285193
Brief Title
Treating Hypertension With Breath Control
Official Title
A Randomized Controlled Trial to Treat Hypertension by Regularising and Slowing Breathing
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
February 2012 (Anticipated)
Study Completion Date
February 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Penang Hospital, Malaysia
Collaborators
Ministry of Health, Malaysia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
hypertension, high blood pressure, treatment, breath control, breathing exercise, audio CD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breath control
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Breath control
Other Intervention Name(s)
breathing exercise, slow breathing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diastolic blood pressure
Description
Change in diastolic blood pressure from baseline to end value at 2 months.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Systolic blood presure
Description
Change in systolic blood pressure from baseline to end value at 2 months.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kum Keong Ng, MBBS
Phone
6042225761
Email
ngkk@crc.gov.my
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kum Keong Ng, MBBS
Organizational Affiliation
Clinical Research Centre, Penang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ng Kum Keong
City
Georgetown
State/Province
Penang
ZIP/Postal Code
10990
Country
Malaysia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kum Keong Ng, MBBS

12. IPD Sharing Statement

Citations:
PubMed Identifier
11319675
Citation
Grossman E, Grossman A, Schein MH, Zimlichman R, Gavish B. Breathing-control lowers blood pressure. J Hum Hypertens. 2001 Apr;15(4):263-9. doi: 10.1038/sj.jhh.1001147.
Results Reference
result
PubMed Identifier
30121686
Citation
Kow FP, Adlina B, Sivasangari S, Punithavathi N, Ng KK, Ang AH, Ong LM. The impact of music guided deep breathing exercise on blood pressure control - A participant blinded randomised controlled study. Med J Malaysia. 2018 Aug;73(4):233-238.
Results Reference
derived

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Treating Hypertension With Breath Control

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