Clinical trial NCT00791986: Loaded Breathing Training in Essential Hypertension
Official title: Effects of Loaded Breathing Training on Blood Pressure in Essential Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Essential Hypertension
Keywords: Breathing exercise
blood pressure
hypertension
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
Collaborators: name: Thai health promotion foundation.
First posted: 2008-11-17
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Home blood pressure
timeFrame: Pre- and post - 8 weeks of intervention at rest
Secondary outcomes:
measure: Office blood pressure
timeFrame: Pre- and post- 8 weeks of intervention at rest
measure: Exercising blood pressure
timeFrame: Blood pressure during exercise at pre- and post-8 weeks of intervention
measure: Heart rate variability
timeFrame: Heart rate variability at pre-and post- 8 weeks of intervention
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Cardiopulmonary Physical Therapy Research Room, Faculty of Asociated Medical Sciences, Khon Kaen University.
Study officials:
affiliation: Department of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University.
name: Chulee U Jones, Ph.D.
role: STUDY_CHAIR
affiliation: Faculty of Physical Therapy, Rungsit University
name: Benjarat Sangthong, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
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.