Uncontrolled HypertensionNCT03320577
Pranayama Breathing and Uncontrolled Hypertension
A study testing Class instruction of breathing exercises and DVD instruction of breathing exercises in people with Uncontrolled Hypertension, run by University of Missouri-Columbia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Uncontrolled Hypertension
- What is being tested?
- Class instruction of breathing exercises and DVD instruction of breathing exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2016to 8 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- comorbidities of COPD, renal disease or chronic alcoholism
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri-Columbia
Columbia, Missouri, 65212
About this study
Official title: Take a Deep Breath: Randomized Controlled Trial of the Effects of Breathing Exercises on Blood Pressure
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.
Read the 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
- Being tested
- Class instruction of breathing exercises, DVD instruction of breathing exercises, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Class instruction of breathing exercisesBehavioural
Pranayama Breathing exercises practiced at least 5 times a week and log practice times
DVD instruction of breathing exercisesBehavioural
Pranayama Breathing exercises practiced at least 5 times a week and log practice times
ControlBehavioural
Log dinner times
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced blood pressure from breathing exercises
5 mmHg point reduction in blood pressure (dichotomous variable) associated with breathing exercises
Measured: Baseline to week 10
Secondary outcomes (4)
Beta blocker medication affect on blood pressure reduction
Differences on blood pressure (mean mmHg) reduction stratified by use of beta blockers (dichotomous)
Measured: Baseline to week 6
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;
Measured: Baseline to week 10
Self Efficacy response to breathing exercises
General self efficacy scale ( point change; range: 10-40) increase in response to breathing exercises
Measured: Baseline to week 18
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
Measured: Baseline to week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start1 Aug 2016
- Primary completion8 Jun 2017
- Study completion8 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncontrolled HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jane McElroy, University of Missouri-Columbia
- Investigators
- Jane A McElroy, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320577
- Sponsor's protocol ID
- 2005875
- Status last verified
- Jul 2023
- First submitted
- 12 Oct 2017
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Take a Deep Breath: Randomized Controlled Trial of the Effects of Breathing Exercises on Blood Pressure
- ClinicalTrials.gov ID
- NCT03320577
- Acronym / sponsor ID
- 2005875
- Conditions
- Uncontrolled Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 8 Jun 2017 (actual)
- Study completion
- 8 Jun 2017 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Class instruction of breathing exercises | Active comparator | Behavioral: Class instruction of breathing exercisesClass 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. |
| DVD instruction of breathing exercises | Active comparator | Behavioral: DVD instruction of breathing exercisesReceived 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. |
| Control | Placebo comparator | Behavioral: ControlCompleted 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- comorbidities of COPD, renal disease or chronic alcoholism
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Class instruction of breathing exercisesPranayama Breathing exercises practiced at least 5 times a week and log practice times | Behavioural | Class instruction of breathing exercises |
| DVD instruction of breathing exercisesPranayama Breathing exercises practiced at least 5 times a week and log practice times | Behavioural | DVD instruction of breathing exercises |
| ControlLog dinner times | Behavioural | Control |
Primary outcome
Reduced blood pressure from breathing exercises
Time frame: Baseline to week 10
5 mmHg point reduction in blood pressure (dichotomous variable) associated with breathing exercises
4 secondary outcomes
Beta blocker medication affect on blood pressure reduction
Time frame: Baseline to week 6
Perceived political stress level of participant affect on blood pressure reduction
Time frame: Baseline to week 10
Self Efficacy response to breathing exercises
Time frame: Baseline to week 18
Depressive severity response to breathing exercises
Time frame: Baseline to week 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane A McElroy, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Class instruction of breathing exercises and DVD instruction of breathing exercises in people with Uncontrolled Hypertension, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced blood pressure from breathing exercises (time frame: Baseline to week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.