Clinical trial NCT00328016: Breathe: Slow Paced Breathing to Lower Blood Pressure
Official title: Respiratory Adaptations to Behavioral Interventions in Elevated Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Blood Pressure
Keywords: hypertension
high blood pressure
meditation
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2006-05-19
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: In this randomized clinical trial, persons with moderately elevated blood pressure were trained in either computer-guided breathing exercises or meditative relaxation to breathing. The computer-guided breathing exercise involves listening to tones of ascending and descending pitch to which breathing is entrained to low frequencies over a 15 minute interval. The meditative relaxation involves passive attention to natural breathing for the same duration. Participants will perform these breathing exercises daily at home for four weeks. Before and after the intervention, respiratory, cardiovascular, and urinary endogenous digitalis-like factors will be systematically recorded to determine the extent to which chronic neuroendocrine changes underlie the reductions in blood pressure.

Eligibility criteria: 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

Primary outcomes:
measure: Breathing Rate
timeFrame: After 15 minutes of guided breathing or control task
Secondary outcomes:
measure: Minute Ventilation
timeFrame: After 15 minutes of guided breathing or control task
measure: End Tidal CO2 (PetCO2)
timeFrame: After 15 minutes of guided breathing or control task
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: NIA Clinical Research Unit
state: Maryland
Study officials:
affiliation: NIA, Clinical research Unit
name: William B. Ershler, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.amjhyper.2003.12.009.
citation: 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. doi: 10.1111/j.1524-6175.2004.03553.x.
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. doi: 10.1038/sj.jhh.1001147.
citation: Benson H. The Relaxation Response. New York: Avon Books, 1975
citation: 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.
citation: Anderson DE, McNeely JD, Windham BG. Regular slow-breathing exercise effects on blood pressure and breathing patterns at rest. J Hum Hypertens. 2010 Dec;24(12):807-13. doi: 10.1038/jhh.2010.18. Epub 2010 Mar 4.