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Pranayama Breathing and Uncontrolled Hypertension

Not Applicable
Completed
Conditions
Uncontrolled Hypertension
Registration Number
NCT03320577
Lead Sponsor
University of Missouri-Columbia
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
103
Inclusion Criteria

Not provided

Exclusion Criteria

comorbidities of COPD, renal disease or chronic alcoholism

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Reduced blood pressure from breathing exercisesBaseline to week 10

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

Secondary Outcome Measures
NameTimeMethod
Beta blocker medication affect on blood pressure reductionBaseline to week 6

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

Depressive severity response to breathing exercisesBaseline 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

Perceived political stress level of participant affect on blood pressure reductionBaseline 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;

Self Efficacy response to breathing exercisesBaseline to week 18

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

Trial Locations

Locations (1)

University of Missouri-Columbia

🇺🇸

Columbia, Missouri, United States

University of Missouri-Columbia
🇺🇸Columbia, Missouri, United States
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