Pranayama Breathing and Uncontrolled Hypertension

Take a Deep Breath: Randomized Controlled Trial of the Effects of Breathing Exercises on Blood Pressure

This study will compare participants who have uncontrolled hypertension and perform a set of five breathing exercises (Pranayama breathing) to a control group. The purpose of the study is to determine the effect of the breathing exercises on reduction of blood pressure.

Study Overview

• Status: Completed
• Conditions: Uncontrolled Hypertension
• Intervention / Treatment: Behavioral: Class instruction of breathing exercises; Behavioral: DVD instruction of breathing exercises; Behavioral: Control

Detailed Description

Untreated or uncontrolled hypertension is a leading cause of heart disease, stroke, and kidney failure. Hypertension, is a modifiable risk factor that may be successfully treated using one or a combination of treatment options, including medication, diet, exercise, tobacco cessation, or complementary and alternative medicine such as breathing exercises. A well-established cascade of adverse health outcomes are associated with hypertension as well as increased mortality rates. For patient-centered care, providing patients with additional strategies for their health care also has the potential to empower the patient, augment patient-physician team approach to the patient's health care, and support the standards of care for treating hypertension. As explained by McCaffrey et al from their focus group work with patients, "Participants do not want prescription medications except as a last resort and feel that conventional medicine overemphasizes prescription medicines. This may be because of a combination of factors including distrust in conventional medicine, fear of side effects from medicines, and an underlying belief that the body can heal itself given the right nutrition, rest, and time"

Using a randomized controlled trial study design with a 1-month and 3-month follow-up, the investigators hypothesize that practicing breathing at least 5 times per week will show a mean reduction in systolic (SBP) and diastolic (DBP) blood pressures in uncontrolled hypertensive patients compared to control patients. Participants will be randomized into one of three arms of the study. For the intervention arm, participants will be either assigned to a weekly class for the pranayama breathing instruction and practice or given a DVD that contains instructions on the breathing exercises and the 15-minute practice session.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri-Columbia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• English-speaking adults
• less than 60 years of age with BP measurements of ≥140/ ≥90 mm Hg
• 60 years of age or older with BP measurements of ≥150/ ≥90 mm Hg
• diagnosed with diabetes with BP measurements of ≥140/ ≥90 mm Hg
• Patients with BP measurements of <180/ <110 mm Hg without hypertensive urgency symptoms

Exclusion Criteria:

comorbidities of COPD, renal disease or chronic alcoholism

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Class instruction of breathing exercises; Class participation/instruction weekly for 6 weeks and requested to practice Pranayama breathing exercises of 15 minute duration for an additional 4x during the week; completed log that indicated time/date/duration of practice; weekly blood pressure measurements and turn in logs; week 10 and week 18 blood pressure measurements also obtained. Survey instruments completed at baseline, week 6, 10, 18.	Behavioral: Class instruction of breathing exercises; Pranayama Breathing exercises practiced at least 5 times a week and log practice times
Active Comparator: DVD instruction of breathing exercises; Received DVD with instructions and 15 minute Pranayama breathing exercises of 15 minute duration. Participants requested to practice breathing exercises 5x during the week for 6 week intervention; completed log that indicated time/date/duration of practice; weekly blood pressure measurements and turn in logs; week 10 and week 18 blood pressure measurements also obtained. Survey instruments completed at baseline, week 6, 10, 18.	Behavioral: DVD instruction of breathing exercises; Pranayama Breathing exercises practiced at least 5 times a week and log practice times
Placebo Comparator: Control; Completed log that indicated time of eating dinner; weekly blood pressure measurements for the 6 week intervention; control participants also turned in dinner time logs; week 10 and week 18 blood pressure measurements also obtained. Survey instruments completed at baseline, week 6, 10, 18.	Behavioral: Control; Log dinner times

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduced blood pressure from breathing exercises	5 mmHg point reduction in blood pressure (dichotomous variable) associated with breathing exercises	Baseline to week 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beta blocker medication affect on blood pressure reduction	Differences on blood pressure (mean mmHg) reduction stratified by use of beta blockers (dichotomous)	Baseline to week 6
Perceived political stress level of participant affect on blood pressure reduction	Differences on blood pressure (mean mmHg / dichotomous 5 mmHg reduction) reduction stratified by participants reported stress using one question about stress related to the 2016 elelction rated on a 5-point Likert scale from high stress (extremely-somewhat) to low stress (slightly-not at all); range 5-1;	Baseline to week 10
Self Efficacy response to breathing exercises	General self efficacy scale ( point change; range: 10-40) increase in response to breathing exercises	Baseline to week 18
Depressive severity response to breathing exercises	% participants who had PHQ-9 Patient Health Questionnaire which screens for depression (score <5 or >9; range 0-27) in response to breathing exercises	Baseline to week 18

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Investigators: Principal Investigator: Jane A McElroy, PhD, University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): June 8, 2017
• Study Completion (Actual): June 8, 2017

Study Registration Dates

• First Submitted: October 12, 2017
• First Submitted That Met QC Criteria: October 20, 2017
• First Posted (Actual): October 25, 2017

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 2005875

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No