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Loaded Breathing Training in Essential Hypertension

This study has been terminated.

(End of study time and budget permission)

Sponsor:

ClinicalTrials.gov Identifier:

NCT00791986

First Posted: November 17, 2008

Last Update Posted: November 17, 2008

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Thai health promotion foundation.

Information provided by:

Khon Kaen University

Purpose

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.

Condition	Intervention
Essential Hypertension	Device: ULB , LB


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Factorial Assignment Masking: None (Open Label) Primary Purpose: Supportive Care
Official Title:	Effects of Loaded Breathing Training on Blood Pressure in Essential Hypertensive Patients

Further study details as provided by Khon Kaen University:

Primary Outcome Measures:

Home blood pressure [ Time Frame: Pre- and post - 8 weeks of intervention at rest ]

Secondary Outcome Measures:

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 ]


Enrollment:	30
Study Start Date:	May 2006
Estimated Study Completion Date:	December 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: control The patients in this control group do not conduct any breathing training.
Experimental: ULB The patients conduct controlled slow breathing training using the WPTB device without inspiratory resistance.	Device: ULB , LB 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. Other Names: Guided breathing training Paced breathing training Controlled breathing training
Experimental: LB The patients breath in against resistance using WPTB device.	Device: ULB , LB 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. Other Names: Guided breathing training Paced breathing training Controlled breathing training

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	35 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of essential hypertension stage I-II

Exclusion Criteria:

Respiratory disease
Diabetes mellitus
Heart disease
Renal disease
Cerebrovascular disease
Dyslipidemia
Pregnancy

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791986

Locations


Thailand
Cardiopulmonary Physical Therapy Research Room, Faculty of Asociated Medical Sciences, Khon Kaen University.
Khon Kaen, Thailand, 40002

Sponsors and Collaborators

Khon Kaen University

Thai health promotion foundation.

Investigators


Study Chair:	Chulee U Jones, Ph.D.	Department of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University.
Principal Investigator:	Benjarat Sangthong, M.Sc.	Faculty of Physical Therapy, Rungsit University

More Information

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.


Responsible Party:	Asst. Prof. Dr. Chulee Jones, Faculty of Associated Medical Sciences, Khon Kaen University.
ClinicalTrials.gov Identifier:	NCT00791986 History of Changes
Other Study ID Numbers:	KKU-475090015-0
First Submitted:	November 14, 2008
First Posted:	November 17, 2008
Last Update Posted:	November 17, 2008
Last Verified:	November 2008

Keywords provided by Khon Kaen University:


Breathing exercise blood pressure hypertension

Additional relevant MeSH terms:


Hypertension Respiratory Aspiration Vascular Diseases Cardiovascular Diseases	Respiration Disorders Respiratory Tract Diseases Pathologic Processes

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