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OpenTrials
Completed

NCT Number: NCT00328016

Breathe: Slow Paced Breathing to Lower 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.

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NIA Clinical Research Unit

Baltimore, Maryland, 21225, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Resperate

Device

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

Primary outcomes

  1. Breathing Rate

    Time frame: After 15 minutes of guided breathing or control task

    Breathing rate was monitored continuously via inductive plethysmography.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

National Institute on Aging (NIA)

Nih

Registry information

Official study title

Respiratory Adaptations to Behavioral Interventions in Elevated Blood Pressure

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
May 19, 2006
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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