Pranayama Breathing and Uncontrolled Hypertension

NCT ID: NCT03320577

Last Updated: 2023-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-01
• Study Completion Date: 2017-06-08

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.

Conditions

Uncontrolled Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Class instruction of breathing exercises

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.

Group Type: ACTIVE_COMPARATOR

Class instruction of breathing exercises

Intervention Type: BEHAVIORAL

Pranayama Breathing exercises practiced at least 5 times a week and log practice times

DVD instruction of breathing exercises

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.

Group Type: ACTIVE_COMPARATOR

DVD instruction of breathing exercises

Intervention Type: BEHAVIORAL

Pranayama Breathing exercises practiced at least 5 times a week and log practice times

Control

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.

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: BEHAVIORAL

Log dinner times

Interventions

Class instruction of breathing exercises

Pranayama Breathing exercises practiced at least 5 times a week and log practice times

Intervention Type: BEHAVIORAL

DVD instruction of breathing exercises

Pranayama Breathing exercises practiced at least 5 times a week and log practice times

Intervention Type: BEHAVIORAL

Control

Log dinner times

Intervention Type: BEHAVIORAL

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

-

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Jane McElroy

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jane A McElroy, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

University of Missouri-Columbia

Columbia, Missouri, United States

Countries

United States

Other Identifiers

2005875

Identifier Type: -

Identifier Source: org_study_id