Effects of Yoga on Physical and Psychological Outcomes in Older Patients Discharged From Cardiac Rehabilitation: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Retention rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Control
Participants in the control group will not receive any intervention but will be provided with printed or electronic versions of the American Heart Association's 'Life's Essential 8' at baseline, which includes information on how to improve and maintain cardiovascular health.
Online Yoga Intervention
Participants in the intervention group will attend two virtual 60-minute gentle yoga sessions per week for 12 weeks.
干预措施: Gentle Yoga (Behavioral)
结局指标
主要结局
Retention rate
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Geunyeong Cha
Principal Investigator
University of Kentucky