A Randomized Controlled Trial of Cardiac Rehabilitation inMyocardial Infarction Patients with Percutaneous Coronary Intervention
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 382
- 试验地点
- 1
- 主要终点
- Physical activity
研究概览
简要总结
This study is a two-group randomized controlled trial with participants who have experienced myocardial infarction and who have already undergone percutaneous coronary intervention as well. At the end of a period of 6 months, the primary outcomes will be measured with respect to physical activity, functional capacity, knowledge related to coronary artery disease, depression scores, medication adherence. Secondary outcome measures will be health related quality of life; anthropometric measures i.e., body mass index, waist circumference; risk profile; biochemical measures i.e., blood pressure, low density lipoprotein, high density lipoprotein, fasting glucose, HbA1c; cost effective implementation of cardiac rehabilitation model and all-cause mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •18-80 years of age
- •Diagnosed myocardial infarction who have undergone percutaneous coronary intervention not at risk due to other comorbidities.
- •Willing to give informed consent
- •Individuals with Acute Myocardial Infarction
- •Patients with New York Heart Association (NYHA) functional class I, II & III symptoms.
排除标准
- •Participants with medical conditions which could put them at risk during physical activity testing or training (e.g., angina) or conditions that could limit the participant’s ability to exercise (e.g., severe orthopaedic or neurologic impairments)
- •Individuals with Prior Myocardial Infarction.
结局指标
主要结局
Physical activity
时间窗: 6 months
Functional capacity
时间窗: 6 months
Depression scores
时间窗: 6 months
Knowledge related to coronary artery disease
时间窗: 6 months
Medication adherence
时间窗: 6 months
次要结局
- Health related quality of life.(Anthropometric measures: Body Mass Index (BMI), Waist circumference.)