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: August 2, 2012
Last verified: August 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Respiratory Adaptations to Behavioral Interventions in Elevated Blood Pressure

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in tidal volume and minute ventilation during guided breathing [ Time Frame: before (10 min), during (15 min) and following (10 min) initial performance of the breathing task, and 28 days later ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in blood pressure, end tidal CO2 and heart rate variability [ Time Frame: during guided breathing and 28 days later ] [ Designated as safety issue: No ]
  • Changes in 24 hour blood pressure and urinary marinobufagenin excretion [ Time Frame: after 28 days of guided breathing ] [ Designated as safety issue: No ]

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: 1 Device: Resperate
The participant will be trained to perform a guided breathing task that involves a chest expansion sensor, battery-powered microcomputer, and earphones
Other Name: Resperate
Active Comparator: 2 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 will be trained in either computer-guided breathing exercises or meditative relaxation. 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:   21 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00328016

Locations
United States, Maryland
Harbor Hospital
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Investigators
Principal Investigator: William B. Ershler, M.D. NIA, Clinical research Unit
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier: NCT00328016     History of Changes
Other Study ID Numbers: AG0067
Study First Received: May 18, 2006
Last Updated: August 2, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
hypertension
high blood pressure
meditation

Additional relevant MeSH terms:
Hypertension
Hypotension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014