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Completed

NCT Number: NCT03320577

Pranayama Breathing and Uncontrolled Hypertension

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.

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Key information

Conditions

Uncontrolled Hypertension

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri-Columbia

Columbia, Missouri, 65212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

-

Treatment and study plan

Class instruction of breathing exercises

Behavioral

Pranayama Breathing exercises practiced at least 5 times a week and log practice times

DVD instruction of breathing exercises

Behavioral

Pranayama Breathing exercises practiced at least 5 times a week and log practice times

Control

Behavioral

Log dinner times

Primary outcomes

  1. Reduced blood pressure from breathing exercises

    Time frame: Baseline to week 10

    5 mmHg point reduction in blood pressure (dichotomous variable) associated with breathing exercises

Secondary outcomes

  1. Beta blocker medication affect on blood pressure reduction

    Time frame: Baseline to week 6

    Differences on blood pressure (mean mmHg) reduction stratified by use of beta blockers (dichotomous)

  2. Perceived political stress level of participant affect on blood pressure reduction

    Time frame: Baseline to week 10

    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;

  3. Self Efficacy response to breathing exercises

    Time frame: Baseline to week 18

    General self efficacy scale ( point change; range: 10-40) increase in response to breathing exercises

  4. Depressive severity response to breathing exercises

    Time frame: Baseline to week 18

    % participants who had PHQ-9 Patient Health Questionnaire which screens for depression (score <5 or >9; range 0-27) in response to breathing exercises

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 25, 2017
Registry last updated
Jul 10, 2023

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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