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Clinical Trials/NCT06235658
NCT06235658
Recruiting
Not Applicable

Effects of Yoga on Physical and Psychological Outcomes in Older Patients Discharged From Cardiac Rehabilitation: A Pilot Study

Geunyeong Cha1 site in 1 country40 target enrollmentNovember 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases in Old Age
Sponsor
Geunyeong Cha
Enrollment
40
Locations
1
Primary Endpoint
Retention rate
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 15, 2023
End Date
December 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Geunyeong Cha
Responsible Party
Sponsor Investigator
Principal Investigator

Geunyeong Cha

Principal Investigator

University of Kentucky

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

Outcomes

Primary Outcomes

Retention rate

Time Frame: Three months

The retention rate will be calculated by dividing the total number of patients by the number of patients who will complete the study and then multiplying it by 100.

Intervention acceptability

Time Frame: Three months

The investigators will use modified versions of the Treatment Acceptability Adherence Scale (TAAS) to assess acceptability of the yoga intervention at 3-months follow-up. The TAAS is a 10-item self-report questionnaire designed to evaluate treatment acceptability and adherence. Items are rated on a 7-point Likert-type scale (1 = disagree strongly; 7 = agree strongly). The total score is a sum of seven items, ranging from 10 to 49 where a higher score means greater adherence.

Recruitment rate

Time Frame: Three months

The recruitment rate (%) will be calculated by dividing the total number of patients enrolled by approached eligible patients and then multiplying it by 100.

Intervention adherence rate

Time Frame: Three months

The intervention adherence rate will be calculated by dividing the total number of sessions attended by the total number of intervention sessions (i.e., 24) and multiplying that number by 100.

Intervention satisfaction

Time Frame: Three months

The investigators will use modified versions of the Client Satisfaction Questionnaire (CSQ) to assess the satisfaction of the yoga intervention at 3-month follow-up. The CSQ is an 8-item self-report questionnaire to evaluate participant satisfaction with a specific intervention. Items are rated on a 4-point Likert-type scale (1 = very satisfied; 4= quite dissatisfied). The total score is the sum of eight items, ranging from 8 to 32, where a higher score indicates greater satisfaction with the intervention. This instrument was validated for patients and has internal consistency reliability.

Secondary Outcomes

  • Change in Brief Symptom Inventory(Baseline and Three months)
  • Change in Vulnerable Elders Survey 13(Baseline and Three months)
  • Change in Balance(Baseline and Three months)
  • Change in Physical activity(Baseline and Three months)
  • Change in Muscle strength(Baseline and Three months)
  • Change in Patient Health Questionnaire-9(Baseline and Three months)
  • Change in Short-term Heart Rate Variability(Baseline and Three months)

Study Sites (1)

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