Effects of a Supervised Versus Non-supervised Exercise Program on Adherence and Functional Outcomes in Colorectal Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Six Minute Walk Test (6MWT)
研究概览
简要总结
Investigation into prehabilitation by increasing the supervision of exercise in patients undergoing colorectal resection for cancer and comparing with patients involved in a rehabilitation group receiving exercise after surgery.
详细描述
The aims of this research project are the following:
To determine to what extent a structured multimodal prehabilitation regimen, which includes aerobic and resistance exercise, nutritional supplementation and psychological coping strategies, initiated before surgery, and continued while in hospital and after surgery, optimizes the recovery of functional walking capacity following colorectal resection for cancer.
To understand 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
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •referred electively for resection of malignant, non metastasized, colorectal lesions.
- •French or English speaking
排除标准
- •ASA class 4-5
- •co-morbid medical, physical and mental conditions (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis)
- •cardiac abnormalities
- •severe end-organ disease such as cardiac failure (New York Heart Association classes I-IV), COPD, renal failure (creatinine > 1.5mg/dl, and hepatic failure ALT and AST > 50% over the normal range)
- •Morbid obesity (BMI > 40)
- •Anemia (hematocrit < 30%, haemoglobin < 10g/dl, albumin < 25mg/dl).
研究组 & 干预措施
Prehabilitation Plus
Patients in this group will be enrolled in a multimodal program before surgery involving supervised exercise, nutrition counseling and relaxation strategies. Supervised exercise is provided once a week for four weeks before surgery as well as during the hospital stay post surgery. Patients are to continue with a home-based exercise program for 8 weeks after discharge.
干预措施: Prehabilitation Plus (Other)
Rehabilitation
Patients in this group are provided with in-hospital supervised exercises with a kinesiologist post surgery until discharge. Patients, upon discharge are provided with a home-based exercise program, nutritional counseling and relaxation strategies for 8 weeks.
结局指标
主要结局
Six Minute Walk Test (6MWT)
时间窗: up to 8 weeks after surgery
Change in functional walking capacity will be assessed throughout the study according to the 6-Minute Walk Test (6MWT). 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
MD
McGill University Health Centre/Research Institute of the McGill University Health Centre