Effect of Baduanjin Sequential Therapy on the Cardiac Function and Exercise Endurance in Patients With AMI and Reduced Ejection Fraction After Primary PCI
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Left ventricular ejection fraction (LVEF)
研究概览
简要总结
Acute myocardial infarction (AMI) is one of the leading causes of death around the world, with the potential for substantial morbidity and mortality. The increasing evidence indicates that exercise training has beneficial effects on LV remodelling in post-MI patients with greater benefits occurring when training earlier following MI, among which the earliest time for rehabilitation is one week after myocardial infarction. However, the effect of Baduanjin sequential therapy for patients after one week of AMI has yet to be assessed. Therefore, the aim of this study is to assess the impact of Baduanjin sequential therapy on cardiac and physical function in patients with AMI and reduced ejection fraction after primary PCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute myocardial infarction undergoing primary percutaneous coronary intervention;
- •Aged 18 years or over and under 80 years;
- •35% < LVEF < 50% and LV < 65mm;
- •With informed consents
排除标准
- •Severe symptomatic congestive heart failure (KILLIP cardiac function class III-IV);
- •Malignant arrhythmias (ventricular fibrillation, ventricular tachycardia, frequent multiple source ventricular premature);
- •Uncontrolled hypertension (systolic blood pressure greater than 160mmhg, diastolic blood pressure greater than 100mmhg);
- •Life-threatening diseases with limited life expectancy <6 months;
- •Inability or difficulty to exercise;
- •Participation in other clinical trials
结局指标
主要结局
Left ventricular ejection fraction (LVEF)
时间窗: baseline and 3 months
The change in echocardiographic measures of left ventricular ejection fraction，(LVEF). LVEF in %.
次要结局
- N-terminal pro-brain natriuretic peptide (NT-pro BNP)(baseline and 3 months)
- Minnesota Satisfaction Questionnaire (MSQ)(baseline and 3 months)
- CPET operators-metabolic equivalent (METs)(baseline and 3 months)
- 6-minute walk distance (6MWD)(baseline and 3 months)
- CPET operators-Peak VO2/kg(baseline and 3 months)
- Exercise compliance-exercise time(baseline and 3 months)
- Exercise compliance-Exercise frequency(baseline and 3 months)
- Generalized Anxiety Disorder 7-item (GAD-7)(baseline and 3 months)
- Patient Health Questionnaire (PHQ-9)(baseline and 3 months)
- Seattle Angina Questionnaire (SAQ)(baseline and 3 months)
- SF-36(baseline and 3 months)
- Traditional Chinese Medicine (TCM) symptom score scale(baseline and 3 months)
- LV end-diastolic volume (LVEDV)(baseline and 3 months)
- CPET operators-peak O2-pulse(baseline and 3 months)
- LV end-systolic volume (LVESV)(baseline and 3 months)
研究者
Han Yaling
Director of cardiology, General Hospital of Northern Theater Command
Shenyang Northern Hospital