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Loaded Breathing Training in Essential Hypertension

Primary Purpose

Essential Hypertension

Status
Terminated
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
ULB , LB
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Essential Hypertension focused on measuring Breathing exercise, blood pressure, hypertension

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of essential hypertension stage I-II

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

control

ULB

LB

Arm Description

The patients in this control group do not conduct any breathing training.

The patients conduct controlled slow breathing training using the WPTB device without inspiratory resistance.

The patients breath in against resistance using WPTB device.

Outcomes

Primary Outcome Measures

Home blood pressure

Secondary Outcome Measures

Office blood pressure
Exercising blood pressure
Heart rate variability

Full Information

First Posted
November 14, 2008
Last Updated
March 5, 2018
Sponsor
Khon Kaen University
Collaborators
Thai health promotion foundation.
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1. Study Identification

Unique Protocol Identification Number
NCT00791986
Brief Title
Loaded Breathing Training in Essential Hypertension
Official Title
Effects of Loaded Breathing Training on Blood Pressure in Essential Hypertensive Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
End of study time and budget permission
Study Start Date
May 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University
Collaborators
Thai health promotion foundation.

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Breathing exercise, blood pressure, hypertension

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
No Intervention
Arm Description
The patients in this control group do not conduct any breathing training.
Arm Title
ULB
Arm Type
Experimental
Arm Description
The patients conduct controlled slow breathing training using the WPTB device without inspiratory resistance.
Arm Title
LB
Arm Type
Experimental
Arm Description
The patients breath in against resistance using WPTB device.
Intervention Type
Device
Intervention Name(s)
ULB , LB
Other Intervention Name(s)
Guided breathing training, Paced breathing training, Controlled breathing training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Home blood pressure
Time Frame
Pre- and post - 8 weeks of intervention at rest
Secondary Outcome Measure Information:
Title
Office blood pressure
Time Frame
Pre- and post- 8 weeks of intervention at rest
Title
Exercising blood pressure
Time Frame
Blood pressure during exercise at pre- and post-8 weeks of intervention
Title
Heart rate variability
Time Frame
Heart rate variability at pre-and post- 8 weeks of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chulee U Jones, Ph.D.
Organizational Affiliation
Department of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Benjarat Sangthong, M.Sc.
Organizational Affiliation
Faculty of Physical Therapy, Rungsit University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiopulmonary Physical Therapy Research Room, Faculty of Asociated Medical Sciences, Khon Kaen University.
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand

12. IPD Sharing Statement

Citations:
Citation
- 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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Loaded Breathing Training in Essential Hypertension

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