- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06155240
Yoga for a Healthy Heart (YHH)
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
Study Overview
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.
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Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ohio
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Warrensville Heights, Ohio, United States, 44122
- South Pointe Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- Unable to tolerate sitting for 1 hour
- BP over 200/100
- Unable to independently walk or use a wheelchair to the bathroom
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Yoga participant
Providing once weekly class for 8 weeks, participants will take part in performing yoga poses and yoga breathing and meditation for stress management
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Yoga interventions include yoga poses, breathing, and meditation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Blood pressure
Time Frame: 8 weeks
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take both systolic and diastolic blood pressure before and after intervention each class and from beginning of session to end of 8 week session
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8 weeks
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Perceived Stress Scale (PSS)
Time Frame: 8 weeks
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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
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8 weeks
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Canadian Occupational Performance Measurement
Time Frame: 8 weeks
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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.
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8 weeks
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Mini and Medi Cog
Time Frame: 8 weeks
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To assess changes in outcomes on managing medications and on short term memory
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8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Allan Chiunda, MD, PhD, South Pointe Hospital
Publications and helpful links
General Publications
- Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Pullen 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.
- Lorig 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.
- 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.
- Ferdinand 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.
- Lam 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.
- Beech 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.
- Basu-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.
- Rana 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.
- Sorrentino 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.
- Ziaeian 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-445
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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