Prehabilitation to Enhance Postoperative Functional Capacity Following Esophageal Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- 6 minute walk test (6MWT)
研究概览
简要总结
Consenting patients scheduled for esophageal resection surgery will be randomized to receive standard nutrition counseling (including nutritional supplements as needed) or standard nutrition counseling and exercise 4 weeks before surgery and 8 weeks after surgery.
It is hypothesized that, compared with the group receiving nutrition alone, the addition of physical exercise to nutrition starting before surgery and continuing for 8 weeks after surgery will have a significantly greater impact on functional walking capacity during the prehabilitation period and during the postoperative period, and on the incidence of postoperative pulmonary complications.
详细描述
A randomized controlled study in patients undergoing esophageal resection for cancer to determine the impact of multimodal prehabilitation on functional exercise capacity and postoperative pulmonary complications. Patients who accept to be enrolled in the study will be randomized to receive either a standard nutritional intervention (including supplements as needed) as per current institution policy or standard nutritional intervention (including supplements as needed) combined with a physical exercise program before and after surgery.
Specific aims
The aims of this research project are the following:
- To determine the extent in which a multimodal prehabilitation regimen optimizes functional recovery in patients suffering from esophageal cancer and the incidence of postoperative pulmonary complications.
- To understand further which measures of immediate surgical recovery are sensitive to prehabilitation interventions, and predict change in later outcome measures.
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
- •18 and older
- •referred electively for resection of malignant esophageal lesion
排除标准
- •American Society of Anesthesiologists (ASA) health status class 4-5
- •Dementia and psychosis
- •Disabling orthopedic and neuromuscular disease
- •Severe cardiac abnormalities
- •Severe end-organ disease such as cardiac failure (New York Heart Association classes I-IV)
- •renal failure (creatinine > 1.5 mg/dl, and hepatic failure ALT and AST >50% over the normal range)
- •Morbid obesity (BMI >30)
- •Anemia (hematocrit < 30 %, haemoglobin <10g/dl, albumin < 25mg/dl)
研究组 & 干预措施
Exercise
Patients in this group will follow standard MUHC protocol of nutritional counseling and supplementation as needed in order to maintain caloric and protein requirements in the preoperative period. Additionally, these patients will be given a specific physical exercise program before and after surgery by kinesiologist.
干预措施: Exercise (Behavioral)
Standard nutrition counselling
Patients in this group will follow standard MUHC protocol of nutritional counseling and supplementation as needed in order to maintain caloric and protein requirements in the preoperative period. This group will receive general instructions on exercises (breathing, ankle rotation) to be done during hospital stay by kinesiologist.
结局指标
主要结局
6 minute walk 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; encouragement and feedback are given according to published guidelines.
次要结局
未报告次要终点
研究者
Franco Carli
Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre