Pranayama Breathing and Uncontrolled Hypertension

University of Missouri (MU)

Status: Completed

Conditions: Uncontrolled Hypertension

Treatments: Behavioral: Control; Behavioral: DVD instruction of breathing exercises; Behavioral: Class instruction of breathing exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT03320577

2005875

Details and patient eligibility

About

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.

Full 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.

Enrollment: 103 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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103 participants in 3 patient groups, including a placebo group

Class instruction of breathing exercises

Active Comparator group

Description:

Class 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.

Treatment:

Behavioral: Class instruction of breathing exercises

DVD instruction of breathing exercises

Active Comparator group

Description:

Received 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.

Treatment:

Behavioral: DVD instruction of breathing exercises

Control

Placebo Comparator group

Description:

Completed 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.

Treatment:

Behavioral: Control