Breathe: Slow Paced Breathing to Lower Blood Pressure

NCT ID: NCT00328016

Last Updated: 2017-07-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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High Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Device Guided Breathing

Individual breathing rate was determined from an expandable band around the torso connected to a commercially available device (RESPeRATE, Lod, Israel) that presented distinctive tones via earphones.

Group Type EXPERIMENTAL

RESPeRATE

Intervention Type DEVICE

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

Control Group

Control group were instructed to sit in the same manner passively attend to their breathing, and silently repeat 'one' during each exhalation. If other thoughts came to mind, they were instructed to calmly attend to their breathing.

Group Type PLACEBO_COMPARATOR

Guided Breathing

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

RESPeRATE

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William B. Ershler, M.D.

Role: PRINCIPAL_INVESTIGATOR

NIA, Clinical research Unit

Locations

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NIA Clinical Research Unit

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15062893 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15470284 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11319675 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type RESULT
PMID: 18820654 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20200548 (View on PubMed)

Other Identifiers

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AG0067

Identifier Type: -

Identifier Source: org_study_id

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