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Loaded Breathing Training in Essential Hypertension

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

Tracking Information
First Submitted Date  ICMJE November 14, 2008
First Posted Date  ICMJE November 17, 2008
Last Update Posted Date March 7, 2018
Study Start Date  ICMJE May 2006
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2008)
Home blood pressure [ Time Frame: Pre- and post - 8 weeks of intervention at rest ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Loaded Breathing Training in Essential Hypertension
Official Title  ICMJE Effects of Loaded Breathing Training on Blood Pressure in Essential Hypertensive Patients
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Essential Hypertension
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Device: ULB , LB
  • Experimental: LB
    The patients breath in against resistance using WPTB device.
    Intervention: Device: ULB , LB
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 14, 2008)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of essential hypertension stage I-II

Exclusion Criteria:

  • Respiratory disease
  • Diabetes mellitus
  • Heart disease
  • Renal disease
  • Cerebrovascular disease
  • Dyslipidemia
  • Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00791986
Other Study ID Numbers  ICMJE KKU-475090015-0
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Benjarat Sangthong, Khon Kaen University
Study Sponsor  ICMJE Khon Kaen University
Collaborators  ICMJE Thai health promotion foundation.
Investigators  ICMJE
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
PRS Account Khon Kaen University
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP