Multimodal Prehabilitation to Enhance Functional Recovery After Lung Surgery
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
- 2
- 主要终点
- Six-minute walk test
研究概览
简要总结
The investigators propose a randomized controlled study in patients undergoing lung resection for cancer to compare the impact of multimodal intervention composed of exercise, nutritional supplement and psychological well-being on functional exercise capacity. One group (rehabilitation group) will receive the multimodal intervention after surgery for 8 weeks; the other will start 4 weeks before surgery and continue for 8 weeks postop (prehabilitation group). In this case, both groups will be exposed to the program, which will be available to both groups postoperatively. One of the two groups will start this program 4 weeks before surgery and continue for 8 weeks postoperatively, and the other will start once they leave the hospital and continue for 8 weeks postoperatively.
详细描述
Interventions
The multidisciplinary program is composed of 3 elements: exercise, nutritional supplements and psychological coping strategies
Exercise program
Patients will be seen by a kinesiologist for a period of 1 hour and he/she will assess patients' mobility and capacity to undertake exercise, will prepare a personalized program and will explain and monitor the exercise program. Patients will be instructed on how to conduct aerobic exercise in the lab and at home, by either walking or cycling initially at 50% of the calculated heart rate reserve for 20 min three times per week, and this will be increased in stepwise increments by 10% each week, if tolerable.
Muscular resistance training will be also carried out 3 times a week to avoid muscle soreness. Persons will be instructed to do push-up, sit-ups, and standing strides (lunges) until volitional fatigue increasing this number to reach 12 repetitions. The resistance chosen for strengthening of biceps, deltoids and quadriceps will be based on what the person can lift to reach volitional fatigue with 8 repetitions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •aged 18 and above
- •referred electively for resection of malignant, non-metastasized lung lesion
排除标准
- •persons with American Society of Anesthesiologists (ASA) health status class 4-5
- •persons with co-morbid medical, physical, and mental abnormalities (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis), cardiac abnormalities, severe end-organ disease such as cardia failure, COPD, renal failure, sepsis, morbid obesity, anemia, and other conditions interfering with the ability to perform exercise at home or to complete testing procedures
- •poor English or French comprehension
研究组 & 干预措施
Prehabilitation
Immediately after randomization, until surgery and to be continued for 8 weeks after 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, until surgery and to be continued for 8 weeks after 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, until surgery and to be continued for 8 weeks after 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 patient in the other arm but to be started after surgery.
干预措施: Whey Protein Isolate Powder (Dietary Supplement)
Rehabilitation
Patients in this arm will receive the same personalized physical exercise program, nutritional intervention and relaxation techniques as patient 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 patient in the other arm but to be started after surgery.
干预措施: Relaxation Techniques (Behavioral)
结局指标
主要结局
Six-minute walk test
时间窗: 8 weeks after surgery
The 6MWT evaluates the ability of an individual to maintain a moderate level of physical activity over a time period reflective of the activities of daily living. Subjects are instructed to walk back and forth, in a 20 m stretch of hallway, for six minutes, at a pace that would make them tired by the end of the walk; encouragement and feedback are given according to published guidelines.
次要结局
- Physical activity level(8 weeks after surgery)
- Nutritional status(8 weeks after surgery)
- Depression and anxiety(8 weeks after surgery)
- Health-related quality of life(8 weeks after surgery)
- Quality of Life(8 weeks after surgery)
研究者
Franco Carli
MD
McGill University Health Centre/Research Institute of the McGill University Health Centre