Pranayama Breathing and Uncontrolled Hypertension

Uncontrolled Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03320577
• Other study ID #: 2005875
• Status: Completed
• Phase: N/A
• Start date: August 1, 2016
• Est. completion date: June 8, 2017

Study information

• Verified date: July 2023
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: June 8, 2017
• Est. primary completion date: June 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

-

Related Conditions & MeSH terms

• Hypertension
• Uncontrolled Hypertension

Intervention

Behavioral:
• Class instruction of breathing exercises
Pranayama Breathing exercises practiced at least 5 times a week and log practice times
• DVD instruction of breathing exercises
Pranayama Breathing exercises practiced at least 5 times a week and log practice times
• Control
Log dinner times

Locations

Country	Name	City	State
United States	University of Missouri-Columbia	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced blood pressure from breathing exercises	5 mmHg point reduction in blood pressure (dichotomous variable) associated with breathing exercises	Baseline to week 10
Secondary	Beta blocker medication affect on blood pressure reduction	Differences on blood pressure (mean mmHg) reduction stratified by use of beta blockers (dichotomous)	Baseline to week 6
Secondary	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;	Baseline to week 10
Secondary	Self Efficacy response to breathing exercises	General self efficacy scale ( point change; range: 10-40) increase in response to breathing exercises	Baseline to week 18
Secondary	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	Baseline to week 18