The Second Affilliated Hospital of Zhejiang University, School of Medicine
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Preoperative physical function
研究概览
简要总结
Aim: To determine the impact of an evidence-based comprehensive prehabilitation (EBCPrehab) program on pre- and postoperative capacity, functional capacity and health related quality of life (HRQoL) in patients awaiting elective coronary artery bypass graft surgery (CABG) or valvular surgery. Design: A single-center randomized controlled trail. SUBJECTS: Overall 160 preoperative elective cardiac surgery patients will be randomly assigned to an intervention or control group. Intervention: one-week EBCPrehab intervention, including supervised exercise, mindfulness and nutrition assessment. Control group: usual care. Main measures: At baseline, one day before surgery, three days after surgery and before discharge. The following measurements will be performed: six-minute walk test, ICU delirium, health related quality of life and flow state.
详细描述
Enhanced recovery improves the quality of recovery following cardiac surgery, while the evidence of prehabilitation is still limited. We hypothesize that the implementation of a comprehensive prehabilitation program, including physical, mental and nutrition support could optimize the postoperative outcomes during hospital stay.
A randomized controlled study of patients undergoing cardiac surgery with prehabilitation approach, is designed to compare patient outcomes. The samples will be collected from hospital registration and the invention will be conducted before surgery. During the 5-day prehabilitation intervention, patients will receive exercises, mindfulness and nutrition risk assessment. After surgery, the 6-minute walk test, delirium assessment, flow state and health related quality of life will be assessed to explore the effects of prehabilitation on patient outcomes.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients awaiting selective coronary artery bypass graft surgery (CABG) or valvular surgery
排除标准
- •Disability, severe psychiatric disease.
研究组 & 干预措施
Intervention group
comprehensive prehabilitation program including supervised exercise., mindfulness and nutrition assessment.
干预措施: Prehabilitation (Behavioral)
Standard care
Standard care before surgery
干预措施: Standard care (Behavioral)
结局指标
主要结局
Preoperative physical function
时间窗: up to 1 week
6-minute walk test distance in meters
Postoperative physical function
时间窗: up to 2 weeks
6-minute walk test distance in meters
次要结局
- ICU delirium(Up to 5 days)
- Health related quality of life(up to 4 weeks)
- Flow State(up to 2 weeks)
- Postoperative delirium(Up to 2 weeks)
- Gut microbiome diversity(up to 2 weeks)
- Short chain fatty acids (SCFAs)(up to 2 weeks)