HypertensionNCT01285193
Treating Hypertension With Breath Control
A study of Hypertension, run by Penang Hospital, Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteMalaysia
- Study dates
- Jun 2011to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- ischaemic heart disease
- congestive heart failure
- cardiac arrhythmias
- renal failure
- diabetes mellitus
- previous stroke
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Ng Kum Keong
George Town, Pulau Pinang, 10990
Kum Keong Ng, MBBS
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Breath control
- Keywords
- hypertension, high blood pressure, treatment, breath control, breathing exercise, audio CD
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath controlBehavioural
Also called breathing exercise, slow breathing
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Breath control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diastolic blood pressure
Change in diastolic blood pressure from baseline to end value at 2 months.
Measured: 2 months
Secondary outcomes (1)
Systolic blood presure
Change in systolic blood pressure from baseline to end value at 2 months.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startJun 2011
- Primary completionFeb 2012 (estimated)
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penang Hospital, Malaysia
- Sponsor type
- Other government
- Collaborators
- Ministry of Health, Malaysia
- Investigators
- Kum Keong Ng, MBBS, Principal investigator, Clinical Research Centre, Penang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285193
- Sponsor's protocol ID
- CT10-HPP-001
- Other IDs
- NMRR-10-686-6238
- Status last verified
- Jan 2011
- First submitted
- 26 Jan 2011
- Last updated
- 27 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11319675Kow 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.
PubMed 30121686
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Treat Hypertension by Regularising and Slowing Breathing
- ClinicalTrials.gov ID
- NCT01285193
- Acronym / sponsor ID
- CT10-HPP-001
- Conditions
- Hypertension
- Keywords
- hypertension, high blood pressure, treatment, breath control, breathing exercise, audio CD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Penang Hospital, MalaysiaOther government
- Collaborators
- Ministry of Health, Malaysia
- Study start
- Jun 2011
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 27 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breath control | Experimental | Behavioral: Breath controlA 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- ischaemic heart disease
- congestive heart failure
- cardiac arrhythmias
- renal failure
- diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breath controlAlso: breathing exercise, slow breathingA 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. | Behavioural | Breath control |
Primary outcome
Diastolic blood pressure
Time frame: 2 months
Change in diastolic blood pressure from baseline to end value at 2 months.
1 secondary outcome
Systolic blood presure
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2011.
- Results publication: PubMed 11319675Grossman 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.
- Derived from this study: PubMed 30121686Kow 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kum Keong Ng, MBBS principal investigator
Clinical Research Centre, Penang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Hypertension, run by Penang Hospital, Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kum Keong Ng, MBBS (6042225761, ngkk@crc.gov.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diastolic blood pressure (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01285193, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2011.