Essential HypertensionNCT00791986
Loaded Breathing Training in Essential Hypertension
A study testing ULB , LB in people with Essential Hypertension, run by Khon Kaen University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine whether adding load to slow controlled breathing training could enhance blood pressure lowering in patients with essential hypertension. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- ULB , LB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- May 2006to Dec 2008
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of essential hypertension stage I-II
Who cannot join
- Respiratory disease
- Diabetes mellitus
- Heart disease
- Renal disease
- Cerebrovascular disease
- Dyslipidemia
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Cardiopulmonary Physical Therapy Research Room, Faculty of Asociated Medical Sciences, Khon Kaen University.
Khon Kaen, 40002
About this study
Official title: Effects of Loaded Breathing Training on Blood Pressure in Essential Hypertensive Patients
The purpose of this study is to determine whether adding load to slow controlled breathing training could enhance blood pressure lowering in patients with essential hypertension.
Read the detailed description
Hypertension (HT) is one of the major risk of cardiovascular diseases and cost of pharmacological treatment is a very high. Lifestyle modification is the first trial in stage 1 hypertension before commencing pharmacological treatment and a co-treatment with drug in hypertensive patient. Slow paced breathing training and physical training has been shown to reduce both systolic and diastolic blood pressure in HT. Moreover loaded breathing was reported to be able to decrease blood pressure in healthy. Loaded slow breathing training may enhance the antihypertensive effect of slow paced breathing.
- Conditions
- Essential Hypertension
- Being tested
- ULB , LB
- Keywords
- Breathing exercise, blood pressure, hypertension
- Medical subject headings
- Essential Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ULB , LBDevice
Also called Guided breathing training, Paced breathing training, Controlled breathing training
ULB: The patients breath in slowly without resistance via the water pressure threshold breathing (WPTB) device, 30 min/day, 7 days/week for 8 weeks.
LB : The patients breath in slowly against resistance of 20 cmH2O provided by the water pressure threshold breathing (WPTB) device, 30 min/day, 7 days/week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | The patients in this control group do not conduct any breathing training. |
| ULB | Experimental | The patients conduct controlled slow breathing training using the WPTB device without inspiratory resistance. Receives: Device: ULB , LB |
| LB | Experimental | The patients breath in against resistance using WPTB device. Receives: Device: ULB , LB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Home blood pressure
Measured: Pre- and post - 8 weeks of intervention at rest
Secondary outcomes (3)
Office blood pressure
Measured: Pre- and post- 8 weeks of intervention at rest
Exercising blood pressure
Measured: Blood pressure during exercise at pre- and post-8 weeks of intervention
Heart rate variability
Measured: Heart rate variability at pre-and post- 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study startMay 2006
- Primary completionDec 2007
- Study completionDec 2008
Why it stopped: End of study time and budget permission
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Essential 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Collaborators
- Thai health promotion foundation.
- Responsible party
- Principal investigator, Benjarat Sangthong, Khon Kaen University
- Investigators
- Chulee U Jones, Ph.D., Study chair, Department of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University.Benjarat Sangthong, M.Sc., Principal investigator, Faculty of Physical Therapy, Rungsit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791986
- Sponsor's protocol ID
- KKU-475090015-0
- Status last verified
- Mar 2018
- First submitted
- 14 Nov 2008
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
- Seals DR, Suwarno NO, Joyner MJ et al.Respiratory modulation of muscle sympathetic nerve activity in intact and lung denervated humans. Circulation Research 72(2): 440-454,1993. - Rosenthal T, Alter A, Peleg E, Gavish B. Device-guided breathing exercises reduce blood pressure: ambulatory and home measurements. Am J Hypertens 14(1):74-76,2001. - Viskoper R, Shapira I, Priluck R et al.Nonpharmacologic treatment of resistant hypertensive by device-guided slow breathing exercises. Am J Hypertens 16(6): 484-487,2003. - Grossman E, Grossman A, Schein MH et al.Breathing-control lowers blood pressure. J Hum Hypertens 15(4): 263-269,2001. - Viskoper R, Shapira I, Priluck R et al.Nonpharmacologic treatment of resistant hypertensive by device-guided slow breathing exercises. Am J Hypertens 16(6):484-487,2003 - Meles E, Giannattasio C, Failla M. et al.Non-pharmacologic treatment of hypertension by respiratory exercise in the home setting. Am J Hypertens 17(4):370-374,2004.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Loaded Breathing Training on Blood Pressure in Essential Hypertensive Patients
- ClinicalTrials.gov ID
- NCT00791986
- Acronym / sponsor ID
- KKU-475090015-0
- Conditions
- Essential Hypertension
- Keywords
- Breathing exercise, blood pressure, hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End of study time and budget permission
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Collaborators
- Thai health promotion foundation.
- Study start
- May 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 17 Nov 2008 (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 whether adding load to slow controlled breathing training could enhance blood pressure lowering in patients with essential hypertension.
Detailed description
Hypertension (HT) is one of the major risk of cardiovascular diseases and cost of pharmacological treatment is a very high. Lifestyle modification is the first trial in stage 1 hypertension before commencing pharmacological treatment and a co-treatment with drug in hypertensive patient. Slow paced breathing training and physical training has been shown to reduce both systolic and diastolic blood pressure in HT. Moreover loaded breathing was reported to be able to decrease blood pressure in healthy. Loaded slow breathing training may enhance the antihypertensive effect of slow paced breathing.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –The patients in this control group do not conduct any breathing training. |
| ULB | Experimental | Device: ULB , LBThe patients conduct controlled slow breathing training using the WPTB device without inspiratory resistance. |
| LB | Experimental | Device: ULB , LBThe patients breath in against resistance using WPTB device. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of essential hypertension stage I-II
Key exclusion criteria (7 listed)
- Respiratory disease
- Diabetes mellitus
- Heart disease
- Renal disease
- Cerebrovascular disease
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 |
|---|---|---|
| ULB , LBAlso: Guided breathing training, Paced breathing training, Controlled breathing trainingULB: The patients breath in slowly without resistance via the water pressure threshold breathing (WPTB) device, 30 min/day, 7 days/week for 8 weeks. LB : The patients breath in slowly against resistance of 20 cmH2O provided by the water pressure threshold breathing (WPTB) device, 30 min/day, 7 days/week for 8 weeks. | Device | LB, ULB |
Primary outcome
Home blood pressure
Time frame: Pre- and post - 8 weeks of intervention at rest
3 secondary outcomes
Office blood pressure
Time frame: Pre- and post- 8 weeks of intervention at rest
Exercising blood pressure
Time frame: Blood pressure during exercise at pre- and post-8 weeks of intervention
Heart rate variability
Time frame: Heart rate variability at pre-and post- 8 weeks of intervention
Results and safety
The study was stopped early (reason given: End of study time and budget permission). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Background- Seals DR, Suwarno NO, Joyner MJ et al.Respiratory modulation of muscle sympathetic nerve activity in intact and lung denervated humans. Circulation Research 72(2): 440-454,1993. - Rosenthal T, Alter A, Peleg E, Gavish B. Device-guided breathing exercises reduce blood pressure: ambulatory and home measurements. Am J Hypertens 14(1):74-76,2001. - Viskoper R, Shapira I, Priluck R et al.Nonpharmacologic treatment of resistant hypertensive by device-guided slow breathing exercises. Am J Hypertens 16(6): 484-487,2003. - Grossman E, Grossman A, Schein MH et al.Breathing-control lowers blood pressure. J Hum Hypertens 15(4): 263-269,2001. - Viskoper R, Shapira I, Priluck R et al.Nonpharmacologic treatment of resistant hypertensive by device-guided slow breathing exercises. Am J Hypertens 16(6):484-487,2003 - Meles E, Giannattasio C, Failla M. et al.Non-pharmacologic treatment of hypertension by respiratory exercise in the home setting. Am J Hypertens 17(4):370-374,2004.
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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.
Chulee U Jones, Ph.D. study chair
Department of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University.
Benjarat Sangthong, M.Sc. principal investigator
Faculty of Physical Therapy, Rungsit University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ULB , LB in people with Essential Hypertension, run by Khon Kaen University at 1 site in Thailand.
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 1 inclusion and 7 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: stopped early, as of the sponsor's last update on 7 Mar 2018. 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 Thailand. 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?
The study was stopped early (reason given: End of study time and budget permission). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Home blood pressure (time frame: Pre- and post - 8 weeks of intervention at rest). 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 NCT00791986, which also lists 1 linked publication.
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 7 Mar 2018.