Prehabilitation to Enhance Postoperative Functional Capacity Following Radical Cystectomy: Combining Physical Exercise to Stress Reduction Strategies and Nutritional Supplementation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Six minute walking test (6MWT)
研究概览
简要总结
The process of enhancing the functional capacity of an individual before an operation to enable him or her to withstand the stress of surgery has been termed prehabilitation. It has been shown that poor baseline capacity for physical performance and poor nutritional status increase the risk of complications after major non cardiac surgery and prolong recovery. A controlled randomized study in patients undergoing radical cystectomy for cancer is therefore proposed to determine the impact of multimodal prehabilitation on functional exercise capacity and functional recovery. Patients who accept to be enrolled in the study will be randomized to either a group receiving a multimodal intervention which includes nutritional supplementation (Immunocal® whey protein) combined with a physical exercise program and stress reduction strategies before and after surgery, or a control group who will receive standard preoperative treatment as per our institution.
详细描述
Study Arms
- Standard group Patients in this group will follow standard MUHC clinical guidelines. This group will receive general instructions on exercises (breathing, ankle rotation) to be done before and after surgery by the preoperative clinic nurse. They will also be seen by a nutritionist who will provide general counseling for healthy eating.
- Prehabilitation group Patients in this group will follow the multimodal protocol consisting of nutritional supplementation, a specific physical exercise program and stress reduction strategies.
Randomization Patients will be assigned to the two groups using a computer-generated randomization process whereby brown sealed envelopes will be prepared and opened after patients' consent has been signed.
Components of prehabilitation
- Nutritional supplementation The nutritional status of patients affected by bladder cancer is directly influenced by the presence of cancer which has an impact on all aspects of intermediary (protein, carbohydrate, lipid, trace element, vitamin) metabolism, and by other factors such as age, adjuvant cancer therapy and stage of the disease. In addition, a patient who is undernourished before surgery has greater risk of morbidity and mortality. The primary goal of nutrition therapy during the perioperative period is thus to optimize nutrient stores pre-operatively and provide adequate nutrition to compensate for the catabolic response of surgery postoperatively. This includes preventing the loss of lean body mass which is inversely correlated with the survival of critically ill patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 and older
- •Referred electively for radical resection of a bladder tumor (may or may not receive adjuvant therapy).
排除标准
- •American Society of Anesthesiologists (ASA) health status class 4-5 or co-morbid medical, physical and mental conditions (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis)
- •Severe cardiac abnormalities
- •Severe end-stage organ disease such as cardiac failure (New York Heart Association classes I-IV)
- •Chronic Obstructive Pulmonary Disease (COPD)
- •Hepatic failure (liver enzymes >50% over the normal range)
- •Morbid obesity (BMI >35)
- •Anemia (hematocrit < 30 %, haemoglobin <100 g/L, albumin < 25 g/L)
- •Poor comprehension of English or French.
研究组 & 干预措施
Control
Patients in this group will follow standard MUHC clinical guidelines. This group will receive general instructions, by the preoperative clinic nurse, on exercises (breathing, ankle rotation) to be done before and after surgery. They will also be seen by a nutritionist who will provide general counseling for healthy eating.
Prehabilitation
Patients in this group will follow the multimodal protocol consisting of nutritional counseling with Immunocal® whey protein supplementation, an individualized physical exercise program, and stress reduction strategies.
干预措施: Prehabilitation (Other)
结局指标
主要结局
Six minute walking test (6MWT)
时间窗: up to 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
次要结局
未报告次要终点
研究者
Franco Carli
MD, MPhil
McGill University Health Centre/Research Institute of the McGill University Health Centre