Clinical trial NCT06155240: Yoga for a Healthy Heart
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single cohort
Primary purpose: TREATMENT

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.

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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Eligibility criteria: 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

Primary outcomes:
measure: Blood pressure
timeFrame: 8 weeks
measure: Perceived Stress Scale (PSS)
timeFrame: 8 weeks
measure: Canadian Occupational Performance Measurement
timeFrame: 8 weeks
measure: Mini and Medi Cog
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Warrensville Heights
country: United States
facility: South Pointe Hospital
state: Ohio
Study officials:
affiliation: South Pointe Hospital
name: Allan Chiunda, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
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