Clinical trial NCT03320577: Pranayama Breathing and Uncontrolled Hypertension
Official title: Take a Deep Breath: Randomized Controlled Trial of the Effects of Breathing Exercises on Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uncontrolled Hypertension
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 103
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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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Primary outcomes:
measure: Reduced blood pressure from breathing exercises
timeFrame: Baseline to week 10
Secondary outcomes:
measure: Beta blocker medication affect on blood pressure reduction
timeFrame: Baseline to week 6
measure: Perceived political stress level of participant affect on blood pressure reduction
timeFrame: Baseline to week 10
measure: Self Efficacy response to breathing exercises
timeFrame: Baseline to week 18
measure: Depressive severity response to breathing exercises
timeFrame: Baseline to week 18
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Jane A McElroy, PhD
role: PRINCIPAL_INVESTIGATOR
References: