Preoperative Excercise Training for Patients Undergoing Coronary Artery Bypass Graft Surgery- A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 2
- 主要终点
- Cardiopulmonary fitness
研究概览
简要总结
Patients (pts) with stable coronary artery disease (CAD) requiring coronary artery bypass graft surgery (CABG) may be physically inactive during the waiting period to avoid further risks. Aim of this study is to investigate the feasibility and safety of a preoperative aerobic exercise training in these pts during the waiting period and to analyze its effects on pre-, peri and postoperative outcomes
详细描述
Pts with stable coronary artery disease (CAD) and indication for elective CABG will be prospectively randomized into a preoperative training group (TG) or a non active control group (CG). Pts in TG have to perform six sessions of aerobic endurance training within two weeks prior to CABG. The following investigations will be performed at baseline, one day before surgery and at the beginning and at the end of cardiac rehabilitation: a maximal symptom limited ergospirometry, assessment of endothelial function (analysing the reactive hyperaemic index (RHI) via a finger-tonometry), assessment of quality of life (QoL) using the MacNew Heart Disease Questionnaire, laboratory testing of ischemic and inflammatory Parameters. Baseline, peri- and postoperative characteristics will be collected.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stable Angina
- •indication for elective CABG surgery
- •functional capacity > 50 watts
- •willingness to participate in the study
排除标准
- •unstable Angina
- •comorbidities precluding performance of aerobic exercise training (e.g. neurological disorders, orthopedic disorders etc)
- •functional Status NYHA IV
- •relevant ventricular arrhythmias
- •hemodynamic significant heart valve disease
- •myocarditis
- •cardiomyopathies
- •left main coronary artery disease > 50%
- •peripheral obstructive disease (Fontaine > IIb)
- •reduced life expectancy < 12 months
- •CABG surgery during the last six months
- •participation in another trial
研究组 & 干预措施
Training Group
Preoperative Exercise Training Optimal medical therapy,
干预措施: Preoperative Exercise Training (Other)
Training Group
Preoperative Exercise Training Optimal medical therapy,
干预措施: Optimal medical therapy (Other)
Control Group
Optimal medical therapy, inactive control group
干预措施: Optimal medical therapy (Other)
结局指标
主要结局
Cardiopulmonary fitness
时间窗: Baseline, prior surgery on hospital admission day, hospital discharge day ( postoperative day 7-14) , after 3 weeks of cardiac rehabilitation
Change of maximal Oxygen consumption
Endothelial function
时间窗: Baseline, prior surgery on hospital admission day, hospital discharge day (postoperative day 7-14), after 3 weeks of cardiac rehabilitation
Change of Reactive hyperemic index (RHI)
次要结局
- Length of hospital stay (LoS)(Within the acute care period)
- Ischemic blood marker 6(Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation)
- Inflammatory blood marker 2(Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation)
- Length of ventilation(Within the acute care period)
- Ischemic blood marker 3(Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation)
- Ischemic blood marker 7(Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation)
- Number of patients with a Pulmonary clinical event(Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation)
- Quality of life Questionnaire 3(Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation)
- Functional capacity(Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation)
- Quality of life Questionnaire 2(Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation)
- Ischemic blood marker 1(Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation)
- Ischemic blood marker 2(Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation)
- Ischemic blood marker 5(Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation)
- Inflammatory blood marker 1(Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation)
- Inflammatory blood marker 3(Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation)
- Arterial stiffness(Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation)
- Quality of life Questionnaire 1(Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation)
- Ischemic blood marker 4(Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation)
- Number of patients with a Clinical Event(Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation)
- Number of patients with a Cardiovascular event(after 30 days and 12 months)
- Number of patients with a Cerebrovascular event(after 30 days and 12 months)