HypertensionYHHNCT06155240
Yoga for a Healthy Heart
A study testing Therapeutic yoga in people with Hypertension, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The Yoga for a Healthy Heart study will address various barriers to both medication management and blood pressure regulation for African American patients with hypertension. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Therapeutic yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2024to 19 Jul 2024
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18
- has transportation to South Pointe Hospital
- Has the ability to walk, or use a wheelchair from the entrance of the building
- Able to attend all 8 sessions
- Diagnosis of hypertension
- African American
Show all 10Show fewer
- Prescribed antihypertensive medication
- Able to stand up from the chair independently
- Able to walk to the bathroom independently with or without a device
- Approved by cardiologist to participate
Who cannot join
- Unable to tolerate sitting for 1 hour
- BP over 200/100
- Unable to independently walk or use a wheelchair to the bathroom
Trial locations and contacts
1 site in 1 country.
United States1 site
South Pointe Hospital
Warrensville Heights, Ohio, 44122
About this study
Official title: Yoga for a Healthy Heart Study: Addressing Stress Management and Functional Cognition as Barriers to Both Medication Management and Blood Pressure Regulation for African American Patients With Hypertension
The Yoga for a Healthy Heart study will address various barriers to both medication management and blood pressure regulation for African American patients with hypertension.
Read the detailed description
The program will take place in person at South Pointe's hospital community outreach center. The program will be an 8-week program, once per week, 60 minutes in length, consisting of meditation, or relaxation, pranayama which are breathing techniques and asana, or physical postures. Yoga, is defined as the fluctuations or roaming tendencies of the mind according the Patanjali's Yoga Sutras. In addition to therapeutic yoga techniques, lifestyle management will be discussed or self-reflections written in journals. Lifestyle management skills include learning how to take blood pressure and manage a pillbox, as well as develop prosocial communication skills through lessons on mindful communication. The classes will be taught in person. The instructor facilitating the program will be a skilled healthcare professional certified in both Occupational Therapy and Yoga teaching at the 500-hour level. The Occupational Therapist will provide both skilled assessments and interventions in the group setting of the community health class. Assessments include: 1. Perceived Stress Scale 2. Canadian Occupational Performance Measurement 3. Mini and Medi-Cog 4. Blood pressure assessments pre and post class.
.
- Conditions
- Hypertension
- Being tested
- Therapeutic yoga
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic yogaBehavioural
Yoga interventions include yoga poses, breathing, and meditation
| Study group | Role | What they receive |
|---|---|---|
| Yoga participant | Experimental | Providing once weekly class for 8 weeks, participants will take part in performing yoga poses and yoga breathing and meditation for stress management Receives: Behavioral: Therapeutic yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
take both systolic and diastolic blood pressure before and after intervention each class and from beginning of session to end of 8 week session
Measured: 8 weeks
Perceived Stress Scale (PSS)
Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. To assess changes in outcomes for perceived stress from beginning of intervention to completion of intervention
Measured: 8 weeks
Canadian Occupational Performance Measurement
Changes in components of the COPM that reflect self-care, productivity, and leisure activities may also be analyzed separately in a similar manner using the participants that have rated a problem within these categories among the 5 most important problems used to calculate their total COPM score.
Measured: 8 weeks
Mini and Medi Cog
To assess changes in outcomes on managing medications and on short term memory
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start24 May 2024
- Primary completion19 Jul 2024
- Study completion19 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single cohort
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allan Chiunda, The Cleveland Clinic
- Investigators
- Allan Chiunda, MD, PhD, Principal investigator, South Pointe Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155240
- Sponsor's protocol ID
- 23-445
- Acronym
- YHH
- Status last verified
- Apr 2026
- First submitted
- 2 Nov 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aggarwal M, Bozkurt B, Panjrath G, Aggarwal B, Ostfeld RJ, Barnard ND, Gaggin H, Freeman AM, Allen K, Madan S, Massera D, Litwin SE; American College of Cardiology's Nutrition and Lifestyle Committee of the Prevention of Cardiovascular Disease Council. Lifestyle Modifications for Preventing and Treating Heart Failure. J Am Coll Cardiol. 2018 Nov 6;72(19):2391-2405. doi: 10.1016/j.jacc.2018.08.2160.
PubMed 30384895Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Ferdinand KC, Yadav K, Nasser SA, Clayton-Jeter HD, Lewin J, Cryer DR, Senatore FF. Disparities in hypertension and cardiovascular disease in blacks: The critical role of medication adherence. J Clin Hypertens (Greenwich). 2017 Oct;19(10):1015-1024. doi: 10.1111/jch.13089. Epub 2017 Aug 30.
PubMed 28856834Lam AY, Anderson K, Borson S, Smith FL. A pilot study to assess cognition and pillbox fill accuracy by community-dwelling older adults. Consult Pharm. 2011 Apr;26(4):256-63. doi: 10.4140/TCP.n.2011.256.
PubMed 21486736Lorig KR, Sobel DS, Stewart AL, Brown BW Jr, Bandura A, Ritter P, Gonzalez VM, Laurent DD, Holman HR. Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalization: a randomized trial. Med Care. 1999 Jan;37(1):5-14. doi: 10.1097/00005650-199901000-00003.
PubMed 10413387Beech BM, Ford C, Thorpe RJ Jr, Bruce MA, Norris KC. Poverty, Racism, and the Public Health Crisis in America. Front Public Health. 2021 Sep 6;9:699049. doi: 10.3389/fpubh.2021.699049. eCollection 2021.
PubMed 34552904Basu-Ray I, Mehta DH, Shah S. Initial Treatment of Hypertension. N Engl J Med. 2018 May 17;378(20):1952-3. doi: 10.1056/NEJMc1804084. No abstract available.
PubMed 29770683Pullen PR, Thompson WR, Benardot D, Brandon LJ, Mehta PK, Rifai L, Vadnais DS, Parrott JM, Khan BV. Benefits of yoga for African American heart failure patients. Med Sci Sports Exerc. 2010 Apr;42(4):651-7. doi: 10.1249/MSS.0b013e3181bf24c4.
PubMed 19952833Rana J, Oldroyd J, Islam MM, Tarazona-Meza CE, Islam RM. Prevalence of hypertension and controlled hypertension among United States adults: Evidence from NHANES 2017-18 survey. Int J Cardiol Hypertens. 2020 Oct 26;7:100061. doi: 10.1016/j.ijchy.2020.100061. eCollection 2020 Dec.
PubMed 33447782Sorrentino MJ. The Evolution from Hypertension to Heart Failure. Heart Fail Clin. 2019 Oct;15(4):447-453. doi: 10.1016/j.hfc.2019.06.005. Epub 2019 Aug 7.
PubMed 31472880Ziaeian B, Fonarow GC. The Prevention of Hospital Readmissions in Heart Failure. Prog Cardiovasc Dis. 2016 Jan-Feb;58(4):379-85. doi: 10.1016/j.pcad.2015.09.004. Epub 2015 Oct 21.
PubMed 26432556
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga for a Healthy Heart Study: Addressing Stress Management and Functional Cognition as Barriers to Both Medication Management and Blood Pressure Regulation for African American Patients With Hypertension
- ClinicalTrials.gov ID
- NCT06155240
- Acronym / sponsor ID
- YHH / 23-445
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 24 May 2024 (actual)
- Primary completion
- 19 Jul 2024 (actual)
- Study completion
- 19 Jul 2024 (actual)
- First posted
- 4 Dec 2023 (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.
The Yoga for a Healthy Heart study will address various barriers to both medication management and blood pressure regulation for African American patients with hypertension.
Detailed description
The program will take place in person at South Pointe's hospital community outreach center. The program will be an 8-week program, once per week, 60 minutes in length, consisting of meditation, or relaxation, pranayama which are breathing techniques and asana, or physical postures. Yoga, is defined as the fluctuations or roaming tendencies of the mind according the Patanjali's Yoga Sutras. In addition to therapeutic yoga techniques, lifestyle management will be discussed or self-reflections written in journals. Lifestyle management skills include learning how to take blood pressure and manage a pillbox, as well as develop prosocial communication skills through lessons on mindful communication. The classes will be taught in person. The instructor facilitating the program will be a skilled healthcare professional certified in both Occupational Therapy and Yoga teaching at the 500-hour level. The Occupational Therapist will provide both skilled assessments and interventions in the group setting of the community health class. Assessments include: 1. Perceived Stress Scale 2. Canadian Occupational Performance Measurement 3. Mini and Medi-Cog 4. Blood pressure assessments pre and post class.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single cohort
| Arm | Type | Receives |
|---|---|---|
| Yoga participant | Experimental | Behavioral: Therapeutic yogaProviding once weekly class for 8 weeks, participants will take part in performing yoga poses and yoga breathing and meditation for stress management |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Over 18
- has transportation to South Pointe Hospital
- Has the ability to walk, or use a wheelchair from the entrance of the building
- Able to attend all 8 sessions
- Diagnosis of hypertension
Key exclusion criteria (3 listed)
- Unable to tolerate sitting for 1 hour
- BP over 200/100
- Unable to independently walk or use a wheelchair to the bathroom
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 |
|---|---|---|
| Therapeutic yogaYoga interventions include yoga poses, breathing, and meditation | Behavioural | Yoga participant |
Primary outcome
Blood pressure
Time frame: 8 weeks
take both systolic and diastolic blood pressure before and after intervention each class and from beginning of session to end of 8 week session
Perceived Stress Scale (PSS)
Time frame: 8 weeks
Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. To assess changes in outcomes for perceived stress from beginning of intervention to completion of intervention
Canadian Occupational Performance Measurement
Time frame: 8 weeks
Changes in components of the COPM that reflect self-care, productivity, and leisure activities may also be analyzed separately in a similar manner using the participants that have rated a problem within these categories among the 5 most important problems used to calculate their total COPM score.
Mini and Medi Cog
Time frame: 8 weeks
To assess changes in outcomes on managing medications and on short term memory
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 13 Apr 2026.
- Background: PubMed 30384895Aggarwal M, Bozkurt B, Panjrath G, Aggarwal B, Ostfeld RJ, Barnard ND, Gaggin H, Freeman AM, Allen K, Madan S, Massera D, Litwin SE; American College of Cardiology's Nutrition and Lifestyle Committee of the Prevention of Cardiovascular Disease Council. Lifestyle Modifications for Preventing and Treating Heart Failure. J Am Coll Cardiol. 2018 Nov 6;72(19):2391-2405. doi: 10.1016/j.jacc.2018.08.2160.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 28856834Ferdinand KC, Yadav K, Nasser SA, Clayton-Jeter HD, Lewin J, Cryer DR, Senatore FF. Disparities in hypertension and cardiovascular disease in blacks: The critical role of medication adherence. J Clin Hypertens (Greenwich). 2017 Oct;19(10):1015-1024. doi: 10.1111/jch.13089. Epub 2017 Aug 30.
- Background: PubMed 21486736Lam AY, Anderson K, Borson S, Smith FL. A pilot study to assess cognition and pillbox fill accuracy by community-dwelling older adults. Consult Pharm. 2011 Apr;26(4):256-63. doi: 10.4140/TCP.n.2011.256.
- Background: PubMed 10413387Lorig KR, Sobel DS, Stewart AL, Brown BW Jr, Bandura A, Ritter P, Gonzalez VM, Laurent DD, Holman HR. Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalization: a randomized trial. Med Care. 1999 Jan;37(1):5-14. doi: 10.1097/00005650-199901000-00003.
- Background: PubMed 34552904Beech BM, Ford C, Thorpe RJ Jr, Bruce MA, Norris KC. Poverty, Racism, and the Public Health Crisis in America. Front Public Health. 2021 Sep 6;9:699049. doi: 10.3389/fpubh.2021.699049. eCollection 2021.
- Background: PubMed 29770683Basu-Ray I, Mehta DH, Shah S. Initial Treatment of Hypertension. N Engl J Med. 2018 May 17;378(20):1952-3. doi: 10.1056/NEJMc1804084. No abstract available.
- Background: PubMed 19952833Pullen PR, Thompson WR, Benardot D, Brandon LJ, Mehta PK, Rifai L, Vadnais DS, Parrott JM, Khan BV. Benefits of yoga for African American heart failure patients. Med Sci Sports Exerc. 2010 Apr;42(4):651-7. doi: 10.1249/MSS.0b013e3181bf24c4.
- Background: PubMed 33447782Rana J, Oldroyd J, Islam MM, Tarazona-Meza CE, Islam RM. Prevalence of hypertension and controlled hypertension among United States adults: Evidence from NHANES 2017-18 survey. Int J Cardiol Hypertens. 2020 Oct 26;7:100061. doi: 10.1016/j.ijchy.2020.100061. eCollection 2020 Dec.
- Background: PubMed 31472880Sorrentino MJ. The Evolution from Hypertension to Heart Failure. Heart Fail Clin. 2019 Oct;15(4):447-453. doi: 10.1016/j.hfc.2019.06.005. Epub 2019 Aug 7.
- Background: PubMed 26432556Ziaeian B, Fonarow GC. The Prevention of Hospital Readmissions in Heart Failure. Prog Cardiovasc Dis. 2016 Jan-Feb;58(4):379-85. doi: 10.1016/j.pcad.2015.09.004. Epub 2015 Oct 21.
- 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.
Allan Chiunda, MD, PhD principal investigator
South Pointe Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic yoga in people with Hypertension, run by The Cleveland Clinic 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 10 inclusion and 3 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 13 Apr 2026. 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. 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?
Blood pressure (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06155240, which also lists 11 linked publications.
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 13 Apr 2026.