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Clinical Trials/NCT03320577
NCT03320577
Completed
Not Applicable

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

University of Missouri-Columbia1 site in 1 country103 target enrollmentAugust 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Uncontrolled Hypertension
Sponsor
University of Missouri-Columbia
Enrollment
103
Locations
1
Primary Endpoint
Reduced blood pressure from breathing exercises
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2016
End Date
June 8, 2017
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jane McElroy

Associate Professor

University of Missouri-Columbia

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • comorbidities of COPD, renal disease or chronic alcoholism

Outcomes

Primary Outcomes

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

  • Beta blocker medication affect on blood pressure reduction(Baseline to week 6)
  • Depressive severity response to breathing exercises(Baseline to week 18)
  • Perceived political stress level of participant affect on blood pressure reduction(Baseline to week 10)
  • Self Efficacy response to breathing exercises(Baseline to week 18)

Study Sites (1)

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