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YHH: Yoga for a Healthy Heart

Sponsor
The Cleveland Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT06155240
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
6.3
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Therapeutic yoga
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single cohortSingle cohort
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 31, 2023
Anticipated Primary Completion Date :
May 11, 2024
Anticipated Study Completion Date :
May 11, 2024

Arms and Interventions

Arm Intervention/Treatment
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

Behavioral: Therapeutic yoga
Yoga interventions include yoga poses, breathing, and meditation

Outcome Measures

Primary Outcome Measures

  1. Blood pressure [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

  2. Perceived Stress Scale (PSS) [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

  3. Canadian Occupational Performance Measurement [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.

  4. Mini and Medi Cog [8 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 South Pointe Hospital Warrensville Heights Ohio United States 44122

Sponsors and Collaborators

  • The Cleveland Clinic

Investigators

  • Principal Investigator: Allan Chiunda, MD, PhD, South Pointe Hospital

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
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, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT06155240
Other Study ID Numbers:
  • 23-445
First Posted:
Dec 4, 2023
Last Update Posted:
Dec 4, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hypertension

Study Results

No Results Posted as of Dec 4, 2023