NCT03320577

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 25, 2017

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

10 months

First QC Date

October 12, 2017

Last Update Submit

July 7, 2023

Conditions

Uncontrolled Hypertension

Outcome Measures

Primary Outcomes (1)

  • Reduced blood pressure from breathing exercises

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

    Baseline to week 10

Secondary Outcomes (4)

  • Beta blocker medication affect on blood pressure reduction

    Baseline to week 6

  • Perceived political stress level of participant affect on blood pressure reduction

    Baseline to week 10

  • Self Efficacy response to breathing exercises

    Baseline to week 18

  • Depressive severity response to breathing exercises

    Baseline to week 18

Study Arms (3)

Class instruction of breathing exercises

ACTIVE COMPARATOR

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.

Behavioral: Class instruction of breathing exercises

DVD instruction of breathing exercises

ACTIVE COMPARATOR

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.

Behavioral: DVD instruction of breathing exercises

Control

PLACEBO COMPARATOR

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.

Behavioral: Control

Interventions

Class instruction of breathing exercisesBEHAVIORAL

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

Class instruction of breathing exercises
DVD instruction of breathing exercisesBEHAVIORAL

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

DVD instruction of breathing exercises
ControlBEHAVIORAL

Log dinner times

Control

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English-speaking adults
  • less than 60 years of age with BP measurements of ≥140/ ≥90 mm Hg
  • 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

You may not qualify if:

  • comorbidities of COPD, renal disease or chronic alcoholism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65212, United States

Location

Study Officials

  • Jane A McElroy, PhD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 12, 2017

First Posted

October 25, 2017

Study Start

August 1, 2016

Primary Completion

June 8, 2017

Study Completion

June 8, 2017

Last Updated

July 10, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)