Breathe: Slow Paced Breathing to Lower Blood Pressure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Respiratory Adaptations to Behavioral Interventions in Elevated Blood Pressure

Conditions
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High Blood Pressure

Intervention / Treatment
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* Behavioral: Guided Breathing
* Device: RESPeRATE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device Guided Breathing<br>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<br>* The participant will be trained to perform a guided breathing task that involves a chest expansion sensor, battery-powered microcomputer, and earphones<br>|
| Placebo Comparator: Control Group<br>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<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, high blood pressure, meditation