Facilitation of Early Mobilization After Colorectal Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Functional walking capacity (six-minute walk test)
研究概览
简要总结
Early mobilization (i.e. initiation of out of bed activities from the day of surgery) is considered an important component of postoperative care after colorectal surgery. Having a health professional dedicated to facilitate early mobilization has the potential to enhance postoperative recovery by preventing the negative effects of prolonged bed rest (e.g. increased risk for complications, muscle loss, deconditioning and functional decline); however, the need to implement this resource-intensive approach is not evidence based. This study aims to contribute evidence about the role of facilitated early mobilization as a strategy to enhance recovery after colorectal surgery.
详细描述
The primary research question of this study is: to what extent does postoperative facilitation of early mobilization impact on recovery of functional walking capacity at 4 weeks after surgery in comparison to standard care (preoperative education).
The hypothesis is that, by 4 weeks after surgery, facilitated early mobilization will result in a greater proportion of participants returning to preoperative levels of functional walking, as measured by the six-minute walk test (6MWT).
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 (Outcomes Assessor)
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
- •Adult people (>18 years)
- •Colonic or rectal diseases (i.e. cancer, inflammatory bowel disease, diverticulitis) planned for surgical resection
排除标准
- •Metastatic disease
- •Medical conditions that preclude postoperative mobilization (e.g. neurological or musculoskeletal diseases)
- •Inability to understand English or French
- •Admission to intensive care immediately after the surgery
研究组 & 干预措施
Facilitated early mobilization
Early mobilization facilitated by a dedicated health professional
干预措施: Facilitated early mobilization (Other)
Usual care
Instructions about early mobilization covered in a preoperative education session
干预措施: Usual care (Other)
结局指标
主要结局
Functional walking capacity (six-minute walk test)
时间窗: before surgery; 4 weeks after surgery
The outcome of interest will be the proportion of participants returning to preoperative levels of functional walking capacity at 4 weeks after surgery (within an estimated measurement error of 20 meters)
次要结局
- Time out of bed (sitting and standing)(postoperative day (POD) 0, 1, 2 and 3)
- Time to readiness for discharge(duration of hospital stay (expected average of 3 days after surgery))
- Time to recovery of gastrointestinal motility(Expected average of 2 days after surgery)
- Postoperative fatigue (Multidimensional Fatigue Inventory)(before surgery; POD 1, 2 and 3; 2 weeks after surgery; 4 weeks after surgery.)
- Self-reported physical activity status (Duke Activity Status Index)(before surgery; 2 weeks after surgery; 4 weeks after surgery)
- Mobility (Life-Space Mobility Assessment)(before surgery; 4 weeks after surgery)
- Condition-specific health-related quality of life (Abdominal Surgery Impact Scale)(before surgery; POD 1, 2 and 3; 2 weeks after surgery; 4 weeks after surgery)
- Generic heath-related quality of life (RAND-36)(before surgery; 4 weeks after surgery)
- Postoperative complications(up to 4 weeks after surgery)
- Pulmonary function (spirometry)(before surgery; POD 1, 2 and 3; 4 weeks after surgery)
研究者
Dr. Liane S. Feldman
MD
McGill University Health Centre/Research Institute of the McGill University Health Centre