Breathe: Slow Paced Breathing to Lower Blood Pressure - Full Text View

Sponsored by:	National Institute on Aging (NIA)
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00328016

Purpose

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.

Condition	Intervention	Phase
High Blood Pressure	Behavioral: Guided Breathing Device: Resperate	Phase III

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Respiratory Adaptations to Behavioral Interventions in Elevated Blood Pressure

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:

Change in tidal volume and minute ventilation during guided breathing [ Time Frame: before (10 min), during (15 min) and following (10 min) initial performance of the breathing task, and 28 days later ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in blood pressure, end tidal CO2 and heart rate variability [ Time Frame: during guided breathing and 28 days later ] [ Designated as safety issue: No ]
Changes in 24 hour blood pressure and urinary marinobufagenin excretion [ Time Frame: after 28 days of guided breathing ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	April 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Device: Resperate The participant will be trained to perform a guided breathing task that involves a chest expansion sensor, battery-powered microcomputer, and earphones
2: Active Comparator	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

Detailed 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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328016

Contacts

Contact: Jessica McNeely, BA

410-350-7379

mcneelyj@grc.nia.nih.gov

Locations

United States, Maryland
Harbor Hospital	Recruiting
Baltimore, Maryland, United States, 21225
Contact: Jessica McNeely, BA 410-350-7379 mcneelyj@grc.nih.nia.gov
Contact: NIA Recruiter 410-350-3941 NIAStudiesRecruitment@mail.nih.gov
Principal Investigator: David E. Anderson, PhD

Sponsors and Collaborators

National Institute on Aging (NIA)

Investigators

Principal Investigator:

David E. Anderson, PhD

NIA, Behavioral Hypertension Unit

More Information

Additional Information:

Breathe Study This link exits the ClinicalTrials.gov site

Publications:

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.

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.

Grossman E, Grossman A, Schein MH, Zimlichman R, Gavish B. Breathing-control lowers blood pressure. J Hum Hypertens. 2001 Apr;15(4):263-9.

Benson H. The Relaxation Response. New York: Avon Books, 1975

Responsible Party:	National Institute on Aging ( David Anderson, Ph.D., Clinical Research Branch )
Study ID Numbers:	AG0067
Study First Received:	May 18, 2006
Last Updated:	August 28, 2008
ClinicalTrials.gov Identifier:	NCT00328016 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

hypertension
high blood pressure
meditation

Study placed in the following topic categories:

Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Vascular Diseases
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009