Breathe: Slow Paced Breathing to Lower Blood Pressure

NCT00328016 | Completed Results

• 1 other identifier: AG0067
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

High Blood Pressure

Keywords

hypertension; high blood pressure; meditation

Outcome Measures

Primary Outcomes (1)

• Breathing Rate

  Breathing rate was monitored continuously via inductive plethysmography.

  After 15 minutes of guided breathing or control task

Secondary Outcomes (2)

• Minute Ventilation

  After 15 minutes of guided breathing or control task

• End Tidal CO2 (PetCO2)

  After 15 minutes of guided breathing or control task

Study Arms (2)

Device Guided Breathing

EXPERIMENTAL

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.

Device: RESPeRATE

Control Group

PLACEBO COMPARATOR

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.

Behavioral: Guided Breathing

Interventions

Guided Breathing 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

Control Group

RESPeRATE DEVICE

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

Device Guided Breathing

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 21 years
• Systolic blood pressure 130-160 or diastolic blood pressure 85-100

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Aging (NIA): lead

Study Sites (1)

NIA Clinical Research Unit

Baltimore, Maryland, 21225, United States

Location

Related Publications (6)

• 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.

  PMID: 15062893 BACKGROUND

• 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.

  PMID: 15470284 BACKGROUND

• 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.

  PMID: 11319675 BACKGROUND

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

  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.

  PMID: 18820654 RESULT

• 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.

  PMID: 20200548 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Jessica McNeeley, Research Fellow
• Organization: National Institute on Aging

mcneeleyj@mail.nih.gov

410-558-8110

Study Officials

• William B. Ershler, M.D.

  NIA, Clinical research Unit

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2006
• First Posted: May 19, 2006
• Study Start: April 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 2, 2017
• Results First Posted: July 2, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)