Loaded Breathing Training in Essential Hypertension

This study has been terminated.
(End of study time and budget permission)
Sponsor:
Collaborator:
Thai health promotion foundation.
Information provided by:
Khon Kaen University
ClinicalTrials.gov Identifier:
NCT00791986
First received: November 14, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effects of Loaded Breathing Training on Blood Pressure in Essential Hypertensive Patients

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Office blood pressure [ Time Frame: Pre- and post- 8 weeks of intervention at rest ] [ Designated as safety issue: No ]
  • Exercising blood pressure [ Time Frame: Blood pressure during exercise at pre- and post-8 weeks of intervention ] [ Designated as safety issue: No ]
  • Heart rate variability [ Time Frame: Heart rate variability at pre-and post- 8 weeks of intervention ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: November 14, 2008
Last Updated: November 14, 2008
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research
Thailand: Ministry of Public Health

Keywords provided by Khon Kaen University:
Breathing exercise
blood pressure
hypertension

Additional relevant MeSH terms:
Respiratory Aspiration
Hypertension
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014