Loaded Breathing Training in Essential Hypertension

• ClinicalTrials.gov Identifier: NCT00791986
• Recruitment Status: Terminated
• First Posted: November 17, 2008
• Last Update Posted: March 7, 2018
• Sponsor: Khon Kaen University
• Collaborator: Thai health promotion foundation.
• Information provided by (Responsible Party): Benjarat Sangthong, Khon Kaen University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Essential Hypertension	Device: ULB , LB	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• 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
• Study Start Date: May 2006
• Actual Primary Completion Date: December 2007
• Actual Study Completion Date: December 2008

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Office blood pressure [ Time Frame: Pre- and post- 8 weeks of intervention at rest ]
2. Exercising blood pressure [ Time Frame: Blood pressure during exercise at pre- and post-8 weeks of intervention ]
3. Heart rate variability [ Time Frame: Heart rate variability at pre-and post- 8 weeks of intervention ]

Eligibility Criteria

• Ages Eligible for Study: 35 Years to 65 Years (Adult, Older 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

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: Benjarat Sangthong, Faculty of associated medical science, Khon Kaen University
• ClinicalTrials.gov Identifier: NCT00791986
• Other Study ID Numbers: KKU-475090015-0
• First Posted: November 17, 2008
• Last Update Posted: March 7, 2018
• Last Verified: March 2018

Keywords provided by Benjarat Sangthong, Khon Kaen University:

Breathing exercise; blood pressure; hypertension

Additional relevant MeSH terms:

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