Clinical trial NCT06235658: Yoga in Older Cardiac Patients
Official title: Effects of Yoga on Physical and Psychological Outcomes in Older Patients Discharged From Cardiac Rehabilitation: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases in Old Age
Keywords: Physical Activity
Yoga
Mind-body therapies
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to compare, at 3 months, the effects of a yoga intervention on physical health, including balance, muscle strength, physical activity levels, cardiac autonomic function, and physical vulnerability, as well as psychological health, including depressive symptoms and anxiety, in cardiac patients who are older than 65 years old and randomized to the intervention or control group. The main questions aim to 1) determine if yoga can improve physical health outcomes such as balance, muscle strength, cardiac function, and physical vulnerability in older adults with cardiovascular disease, and 2) determine if yoga can positively impact psychological health, including reducing depressive symptoms and anxiety in this population. Participants in the intervention group will attend yoga sessions twice a week for three months. The intervention group will be asked to complete surveys and physical function assessments at the beginning and three months later. Researchers will compare the intervention group and the control group to see if there is any difference and improvement in physical and psychological health between the two groups.


Eligibility criteria: Inclusion Criteria:

* have a history of an acute myocardial infarction within the preceding year, stable angina, cardiac surgery (including heart transplantation, valve surgery, or coronary artery bypass), coronary artery angioplasty or stents, or heart failure (ejection fraction \< 35%) diagnosed in the past year
* have completed facility-based cardiac rehabilitation program (phase CR-II) within 12 months
* can read and understand English
* have no major comorbidities limiting their ability to participate in a yoga intervention
* reside in Kentucky.

Exclusion Criteria:

* have incapacitating neurologic, orthopedic, or neoplastic conditions such as stroke paralysis, terminal cancer, or a cognitive disorder
* currently practice yoga
* have no home WIiFi access

Primary outcomes:
measure: Recruitment rate
timeFrame: Three months
measure: Retention rate
timeFrame: Three months
measure: Intervention adherence rate
timeFrame: Three months
measure: Intervention acceptability
timeFrame: Three months
measure: Intervention satisfaction
timeFrame: Three months
Secondary outcomes:
measure: Change in Patient Health Questionnaire-9
timeFrame: Baseline and Three months
measure: Change in Brief Symptom Inventory
timeFrame: Baseline and Three months
measure: Change in Vulnerable Elders Survey 13
timeFrame: Baseline and Three months
measure: Change in Short-term Heart Rate Variability
timeFrame: Baseline and Three months
measure: Change in Muscle strength
timeFrame: Baseline and Three months
measure: Change in Balance
timeFrame: Baseline and Three months
measure: Change in Physical activity
timeFrame: Baseline and Three months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Debra K Moser, Ph.D
role: STUDY_CHAIR
References: