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Yoga for a Healthy Heart

NCT ID: NCT06155240

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-31

Study Completion Date

2024-05-11

Brief Summary

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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

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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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Conditions

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Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single cohort
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Therapeutic yoga

Intervention Type BEHAVIORAL

Yoga interventions include yoga poses, breathing, and meditation

Interventions

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Therapeutic yoga

Yoga interventions include yoga poses, breathing, and meditation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Allan Chiunda

Principle Investigator, The Brentwood Foundation Chair in Research and Data Analytics | Director of Cleveland Clinic South Pointe Hospital Clinical Effectiveness, Initiatives and Innovations, MD, PhD, MPH

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Allan Chiunda, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

South Pointe Hospital

Locations

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South Pointe Hospital

Warrensville Heights, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lynda Robinson, BS

Role: CONTACT

Phone: 216-491-7297.

Email: [email protected]

Allan Chiunda, MD, PhD

Role: CONTACT

Phone: 216-491-7014

Email: [email protected]

Facility Contacts

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Lynda Robinson, BS

Role: primary

Allan Chiunda, MD, PhD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 30384895 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6668417 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28856834 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21486736 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10413387 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34552904 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29770683 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19952833 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33447782 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31472880 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26432556 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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23-445

Identifier Type: -

Identifier Source: org_study_id