Using Multimodal Prehabilitation to Improve Outcomes for Frail Patients Undergoing Resection of Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Post operative complications
研究概览
简要总结
The purpose of this study is to determine if a program of physical activity, nutritional supplements and relaxation techniques is effective at decreasing post operative complications in frail colorectal cancer patients undergoing resection.
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 (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colorectal cancer patient undergoing resection
- •Frail or intermediately frail patients (Fried score 2 and above)
排除标准
- •Unable to communicate in French or English
- •Premorbid conditions contraindicating physical exercise (dementia, Parkinson Disease, previous stroke with paresis, taking carbidopa/levodopa, donepezil or antidepressants)
研究组 & 干预措施
Prehabilitation
Immediately after randomization and until surgery, patients in this arm will:
-
- Receive a personalized physical exercise program
-
- Receive nutritional counselling with Whey protein isolate powder
-
- Receive relaxation techniques
干预措施: Physical Exercise Program (Behavioral)
Prehabilitation
Immediately after randomization and until surgery, patients in this arm will:
-
- Receive a personalized physical exercise program
-
- Receive nutritional counselling with Whey protein isolate powder
-
- Receive relaxation techniques
干预措施: Whey Protein Isolate Powder (Dietary Supplement)
Prehabilitation
Immediately after randomization and until surgery, patients in this arm will:
-
- Receive a personalized physical exercise program
-
- Receive nutritional counselling with Whey protein isolate powder
-
- Receive relaxation techniques
干预措施: Relaxation Techniques (Behavioral)
Rehabilitation
Patients in this arm will receive the same personalized physical exercise program, nutritional intervention and relaxation techniques as patients in the other arm but to be started after surgery.
干预措施: Relaxation Techniques (Behavioral)
Rehabilitation
Patients in this arm will receive the same personalized physical exercise program, nutritional intervention and relaxation techniques as patients in the other arm but to be started after surgery.
干预措施: Physical Exercise Program (Behavioral)
Rehabilitation
Patients in this arm will receive the same personalized physical exercise program, nutritional intervention and relaxation techniques as patients in the other arm but to be started after surgery.
干预措施: Whey Protein Isolate Powder (Dietary Supplement)
结局指标
主要结局
Post operative complications
时间窗: 30 days after surgery
Comprehensive Complication Index (CCI)
次要结局
- 6 Minutes Walk Test Distance(4 weeks after discharge)
- Readmission rates(30 days after discharge)
- Hospital Length of Stay(3-6 days)
- Anxiety and Depression(30 days after discharge)
- Health Related Quality of Life(30 days after discharge)
研究者
Franco Carli
Professor, Montreal General Hospital Department of Anesthesia
McGill University Health Centre/Research Institute of the McGill University Health Centre