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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00791986
Other study ID # KKU-475090015-0
Secondary ID
Status Terminated
Phase N/A
First received November 14, 2008
Last updated March 5, 2018
Start date May 2006
Est. completion date December 2008

Study information

Verified date March 2018
Source Khon Kaen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 30
Est. completion date December 2008
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender All
Age group 35 Years to 65 Years
Eligibility Inclusion Criteria:

- Clinical diagnosis of essential hypertension stage I-II

Exclusion Criteria:

- Respiratory disease

- Diabetes mellitus

- Heart disease

- Renal disease

- Cerebrovascular disease

- Dyslipidemia

- Pregnancy

Study Design


Intervention

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.

Locations

Country Name City State
Thailand Cardiopulmonary Physical Therapy Research Room, Faculty of Asociated Medical Sciences, Khon Kaen University. Khon Kaen

Sponsors (2)

Lead Sponsor Collaborator
Khon Kaen University Thai health promotion foundation.

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

- 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.

Outcome

Type Measure Description Time frame Safety issue
Primary Home blood pressure Pre- and post - 8 weeks of intervention at rest
Secondary Office blood pressure Pre- and post- 8 weeks of intervention at rest
Secondary Exercising blood pressure Blood pressure during exercise at pre- and post-8 weeks of intervention
Secondary Heart rate variability Heart rate variability at pre-and post- 8 weeks of intervention
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