Breathe: Slow Paced Breathing to Lower Blood Pressure

Respiratory Adaptations to Behavioral Interventions in Elevated Blood Pressure

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.

Study Overview

• Status: Completed
• Conditions: High Blood Pressure
• Intervention / Treatment: Device: RESPeRATE; Behavioral: Guided Breathing

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • NIA Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: RESPeRATE; The participant will be trained to perform a guided breathing task that involves a chest expansion sensor, battery-powered microcomputer, and earphones
Placebo Comparator: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breathing Rate	Breathing rate was monitored continuously via inductive plethysmography.	After 15 minutes of guided breathing or control task

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minute Ventilation	Minute Ventilation was continuously monitored via inductive plethysmography	After 15 minutes of guided breathing or control task
End Tidal CO2 (PetCO2)	End tidal CO2 was monitored continuously using a respiratory gas monitor	After 15 minutes of guided breathing or control task

Collaborators and Investigators

• Sponsor: National Institute on Aging (NIA)
• Investigators: Principal Investigator: William B. Ershler, M.D., NIA, Clinical research Unit

Publications and helpful links

General 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. doi: 10.1016/j.amjhyper.2003.12.009.
• 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.
• 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.
• Benson H. The Relaxation Response. New York: Avon Books, 1975
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: May 18, 2006
• First Submitted That Met QC Criteria: May 18, 2006
• First Posted (Estimate): May 19, 2006

Study Record Updates

• Last Update Posted (Actual): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 5, 2017
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: hypertension; meditation; high blood pressure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: AG0067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual level data.