NCT01285193

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Jun 2011

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

January 27, 2011

Status Verified

January 1, 2011

Enrollment Period

8 months

First QC Date

January 26, 2011

Last Update Submit

January 26, 2011

Conditions

Hypertension

Keywords

hypertensionhigh blood pressuretreatmentbreath controlbreathing exerciseaudio CD

Outcome Measures

Primary Outcomes (1)

  • Diastolic blood pressure

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

    2 months

Secondary Outcomes (1)

  • Systolic blood presure

    2 months

Study Arms (1)

Breath control

EXPERIMENTAL

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

Interventions

Breath controlBEHAVIORAL

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.

Also known as: breathing exercise, slow breathing
Breath control

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ng Kum Keong

George Town, Pulau Pinang, 10990, Malaysia

Location

Related Publications (2)

  • 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.

    PMID: 11319675RESULT

  • 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.

    PMID: 30121686DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Kum Keong Ng, MBBS

    Clinical Research Centre, Penang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kum Keong Ng, MBBS

CONTACT

6042225761ngkk@crc.gov.my

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 26, 2011

First Posted

January 27, 2011

Study Start

June 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

January 27, 2011

Record last verified: 2011-01

Locations

MY(1)