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Breathe: Slow Paced Breathing to Lower Blood Pressure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier:
NCT00328016
First received: May 18, 2006
Last updated: June 5, 2017
Last verified: December 2016
  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
High Blood Pressure Behavioral: Guided Breathing Device: RESPeRATE

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Treatment
Official Title: Respiratory Adaptations to Behavioral Interventions in Elevated Blood Pressure

Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) ):

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


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

  • 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


Enrollment: 44
Study Start Date: April 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00328016     History of Changes
Other Study ID Numbers: AG0067
Study First Received: May 18, 2006
Results First Received: April 30, 2013
Last Updated: June 5, 2017
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) ):
hypertension
high blood pressure
meditation

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 16, 2017