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Pranayama Breathing and Uncontrolled Hypertension

Not Applicable
Completed
Conditions
Uncontrolled Hypertension
Interventions
Behavioral: Class instruction of breathing exercises
Behavioral: DVD instruction of breathing exercises
Behavioral: Control
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
Arm && Interventions
GroupInterventionDescription
Class instruction of breathing exercisesClass instruction of breathing exercisesClass 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.
DVD instruction of breathing exercisesDVD instruction of breathing exercisesReceived 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.
ControlControlCompleted 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.
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

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