Breathe: Slow Paced Breathing to Lower Blood Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00328016
Recruitment Status : Completed
First Posted : May 19, 2006
Results First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )

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.

Condition or disease Intervention/treatment Phase
High Blood Pressure Behavioral: Guided Breathing Device: RESPeRATE Not Applicable

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  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Respiratory Adaptations to Behavioral Interventions in Elevated Blood Pressure
Study Start Date : April 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

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.
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

Primary Outcome Measures :
  1. Breathing Rate [ Time Frame: After 15 minutes of guided breathing or control task ]
    Breathing rate was monitored continuously via inductive plethysmography.

Secondary Outcome Measures :
  1. Minute Ventilation [ Time Frame: After 15 minutes of guided breathing or control task ]
    Minute Ventilation was continuously monitored via inductive plethysmography

  2. End Tidal CO2 (PetCO2) [ Time Frame: After 15 minutes of guided breathing or control task ]
    End tidal CO2 was monitored continuously using a respiratory gas monitor

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00328016

United States, Maryland
NIA Clinical Research Unit
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
National Institute on Aging (NIA)
Principal Investigator: William B. Ershler, M.D. NIA, Clinical research Unit

Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: National Institute on Aging (NIA) Identifier: NCT00328016     History of Changes
Other Study ID Numbers: AG0067
First Posted: May 19, 2006    Key Record Dates
Results First Posted: July 2, 2017
Last Update Posted: July 2, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual level data.

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) ):
high blood pressure

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases