High Blood Pressure Clinical Trial
Official title:
Respiratory Adaptations to Behavioral Interventions in Elevated Blood Pressure
The purpose of this study is to investigate the nature of the physiological reasons for the decreases in resting blood pressure that can result from systematic practice of computer-guided breathing exercises or meditative relaxation.
Status | Completed |
Enrollment | 44 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - Over 21 years - Systolic blood pressure 130-160 or diastolic blood pressure 85-100 Exclusion Criteria: - More than one antihypertensive medication - Beta blockers, angiotensin converting enzyme inhibitors or angiotensin receptor blockers - History of coronary artery disease, heart failure, stroke, angina or coronary revascularization - Kidney disease, defined as plasma creatinine > 1.5mg/dL - Diabetes, defined by insulin or oral hypoglycemic medication or blood sugar > 126mg/dL - Pulmonary disease, defined as chronic obstructive pulmonary disease, bronchitis, asthma, or use of inhaler - Upper respiratory infection during past 30 days - Medication that affects central nervous system function - Steroid use - Current pregnancy or lactation within past six months - Current birth control medication or hormone replacement therapy - Condition that in the judgment of the Principal Investigator is incompatible with the research study |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Harbor Hospital | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute on Aging (NIA) |
United States,
Anderson DE, McNeely JD, Chesney MA, Windham BG. Breathing variability at rest is positively associated with 24-h blood pressure level. Am J Hypertens. 2008 Dec;21(12):1324-9. doi: 10.1038/ajh.2008.292. Epub 2008 Sep 25. — View Citation
Benson H. The Relaxation Response. New York: Avon Books, 1975
Elliot WJ, Izzo JL Jr, White WB, Rosing DR, Snyder CS, Alter A, Gavish B, Black HR. Graded blood pressure reduction in hypertensive outpatients associated with use of a device to assist with slow breathing. J Clin Hypertens (Greenwich). 2004 Oct;6(10):553-9; quiz 560-1. — View Citation
Grossman E, Grossman A, Schein MH, Zimlichman R, Gavish B. Breathing-control lowers blood pressure. J Hum Hypertens. 2001 Apr;15(4):263-9. — View Citation
Meles E, Giannattasio C, Failla M, Gentile G, Capra A, Mancia G. Nonpharmacologic treatment of hypertension by respiratory exercise in the home setting. Am J Hypertens. 2004 Apr;17(4):370-4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in tidal volume and minute ventilation during guided breathing | before (10 min), during (15 min) and following (10 min) initial performance of the breathing task, and 28 days later | No | |
Secondary | Changes in blood pressure, end tidal CO2 and heart rate variability | during guided breathing and 28 days later | No | |
Secondary | Changes in 24 hour blood pressure and urinary marinobufagenin excretion | after 28 days of guided breathing | No |
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