NCT06155240

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable hypertension

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 4, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

May 24, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2024

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

November 2, 2023

Last Update Submit

April 8, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    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.

    8 weeks

  • Mini and Medi Cog

    To assess changes in outcomes on managing medications and on short term memory

    8 weeks

Study Arms (1)

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

Behavioral: Therapeutic yoga

Interventions

Yoga interventions include yoga poses, breathing, and meditation

Yoga participant

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unable to tolerate sitting for 1 hour
  • BP over 200/100
  • Unable to independently walk or use a wheelchair to the bathroom

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Pointe Hospital

Warrensville Heights, Ohio, 44122, United States

Location

Related Publications (11)

  • 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.

    PMID: 30384895BACKGROUND
  • 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.

    PMID: 6668417BACKGROUND
  • 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.

    PMID: 28856834BACKGROUND
  • 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.

    PMID: 21486736BACKGROUND
  • 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.

    PMID: 10413387BACKGROUND
  • 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.

    PMID: 34552904BACKGROUND
  • 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.

    PMID: 29770683BACKGROUND
  • 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.

    PMID: 19952833BACKGROUND
  • 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.

    PMID: 33447782BACKGROUND
  • 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.

    PMID: 31472880BACKGROUND
  • 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.

    PMID: 26432556BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Allan Chiunda, MD, PhD

    South Pointe Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single cohort
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
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

Study Record Dates

First Submitted

November 2, 2023

First Posted

December 4, 2023

Study Start

May 24, 2024

Primary Completion

July 19, 2024

Study Completion

July 19, 2024

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations