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Pranayama Breathing and Uncontrolled Hypertension

Primary Purpose

Uncontrolled Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Class instruction of breathing exercises
DVD instruction of breathing exercises
Control
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uncontrolled Hypertension

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

-

Sites / Locations

  • University of Missouri-Columbia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Class instruction of breathing exercises

DVD instruction of breathing exercises

Control

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Reduced blood pressure from breathing exercises
5 mmHg point reduction in blood pressure (dichotomous variable) associated with breathing exercises

Secondary Outcome Measures

Beta blocker medication affect on blood pressure reduction
Differences on blood pressure (mean mmHg) reduction stratified by use of beta blockers (dichotomous)
Perceived political stress level of participant affect on blood pressure reduction
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 exercises
General self efficacy scale ( point change; range: 10-40) increase in response to breathing exercises
Depressive severity response to breathing exercises
% participants who had PHQ-9 Patient Health Questionnaire which screens for depression (score <5 or >9; range 0-27) in response to breathing exercises

Full Information

First Posted
October 12, 2017
Last Updated
July 7, 2023
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT03320577
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
June 8, 2017 (Actual)
Study Completion Date
June 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncontrolled Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Class instruction of breathing exercises
Arm Type
Active Comparator
Arm 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.
Arm Title
DVD instruction of breathing exercises
Arm Type
Active Comparator
Arm 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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Class instruction of breathing exercises
Intervention Description
Pranayama Breathing exercises practiced at least 5 times a week and log practice times
Intervention Type
Behavioral
Intervention Name(s)
DVD instruction of breathing exercises
Intervention Description
Pranayama Breathing exercises practiced at least 5 times a week and log practice times
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Log dinner times
Primary Outcome Measure Information:
Title
Reduced blood pressure from breathing exercises
Description
5 mmHg point reduction in blood pressure (dichotomous variable) associated with breathing exercises
Time Frame
Baseline to week 10
Secondary Outcome Measure Information:
Title
Beta blocker medication affect on blood pressure reduction
Description
Differences on blood pressure (mean mmHg) reduction stratified by use of beta blockers (dichotomous)
Time Frame
Baseline to week 6
Title
Perceived political stress level of participant affect on blood pressure reduction
Description
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;
Time Frame
Baseline to week 10
Title
Self Efficacy response to breathing exercises
Description
General self efficacy scale ( point change; range: 10-40) increase in response to breathing exercises
Time Frame
Baseline to week 18
Title
Depressive severity response to breathing exercises
Description
% participants who had PHQ-9 Patient Health Questionnaire which screens for depression (score <5 or >9; range 0-27) in response to breathing exercises
Time Frame
Baseline to week 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane A McElroy, PhD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri-Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Pranayama Breathing and Uncontrolled Hypertension

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