Breathe: Slow Paced Breathing to Lower Blood Pressure

High Blood Pressure Clinical Trial

Official title:

Respiratory Adaptations to Behavioral Interventions in Elevated Blood Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00328016
• Other study ID #: AG0067
• Status: Completed
• Phase: N/A
• First received: May 18, 2006
• Last updated: August 2, 2012
• Start date: April 2006
• Est. completion date: December 2009

Study information

• Verified date: August 2012
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

In this randomized clinical trial, persons with moderately elevated blood pressure will be trained in either computer-guided breathing exercises or meditative relaxation. 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• High Blood Pressure
• Hypertension

Intervention

Behavioral:
• Guided Breathing
The participant will engage in daily 15 min sessions of meditative relaxation that involves quiet attention to breathing pattern with no attempt to manipulate breathing pattern

Device:
• Resperate
The participant will be trained to perform a guided breathing task that involves a chest expansion sensor, battery-powered microcomputer, and earphones

Locations

Country	Name	City	State
United States	Harbor Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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

Outcome

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