Early Intensive Mobilization Following Acute High-risk Abdominal Surgery - a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mobilization within 24 hours after surgery assessed by CAS
研究概览
简要总结
Acute High-risk abdominal surgery (AHA) is associated with high mortality rates, multiple postoperative complications and prolonged duration of hospital admission. A recent study revealed very low level of physical performance in the first postoperative week in patients undergoing AHA. Furthermore the included patients who were non-independently mobilized or had low level of 24-hour physical activity more often experienced a pulmonary complication. Studies examining the feasibility of early and intensive mobilization are needed, prior to investigating the effect of the intervention in an Randomised Controlled Trial. The purpose of this study is evaluating the feasibility of early and intensive mobilization during the first week postoperatively among patients who receive Acute High-Risk Abdominal Surgery (AHA). The aim is also to describe physical performance, physical activity, pulmonary function and health-related quality of life, as well as barriers to mobilization following AHA surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Patients (18 years and older) undergoing emergency laparotomy or laparoscopy (inclusive reoperations after elective surgery).
排除标准
- •Patients undergoing minor emergency operations (uncomplicated appendectomy, laparoscopic cholecystectomy, diagnostic laparoscopy or laparotomy without intervention).
- •Patients not able to give consent to participation in the study within 48 hours after surgery.
结局指标
主要结局
Mobilization within 24 hours after surgery assessed by CAS
时间窗: Up to 24 hours after surgery
Percentage of participants that is mobilized within 24 hours after surgery assessed by the Cumulated Ambulation Score (CAS). Pre-defined criteria of feasibility; \>=80% feasible, 60-79% potentially feasible, and \<60% considered not feasible.
Time out of bed (minutes per day) assessed by a accelerometer
时间窗: Up to 7 days after surgery
Percentage of participants able to meet the predefined daily targets of time out of bed (minutes per day) assessed by a accelerometer recording time spent in lying, sitting and standing/walking. Pre-defined criteria of feasibility; \>=80% feasible, 60-79% potentially feasible, and \<60% considered not feasible.
Mobilization 4 times a day registered in a journal
时间窗: Up to 7 days after surgery
Percentage of participants mobilized 4 times a day registered by the hospital staff in a journal. Pre-defined criteria of feasibility; \>=80% feasible, 60-79% potentially feasible, and \<60% considered not feasible.
Able to complete the outcome measures: NRS, VAFS, CST, Peakflow and EQ-5D-5L
时间窗: Up to 7 days after surgery
Percentage of participants able to complete the selected outcome measures: Numeric Rating scale (NRS), Visual Analog Fatigue Scale (VAFS), 30-second Chair Stand Test (CST), Peakflow meter and health-related quality of life EQ-5D-5L. Pre-defined criteria of feasibility; \>=80% feasible, 60-79% potentially feasible, and \<60% considered not feasible.
次要结局
- Visual Analog Fatigue Scale (VAFS, 0-10 points)(Up to 7 days after surgery)
- Pain assessed by Numeric Rating scale (NRS, 0-10 points)(Up to 7 days after surgery)
- Cumulated Ambulation Score (CAS, 0-6 points)(Up to 7 days after surgery)
- 30-second Chair Stand Test (CST)(Up to 7 days after surgery)
- Functional independence in Activity of Daily Living assessed by Barthel Index (BI, 0-100 points)(Up to 7 days after surgery)
- 24-hour physical activity (minutes per day)(Up to 7 days after surgery)
- Postoperative Pulmonary complication(Up to 2 weeks after surgery)
- Pulmonary function assessed by Peak flow meter(Up to 7 days after surgery)
- Health-related quality of life assessed by EQ-5D-5L (0-100 points)(Up to 7 days after surgery)
研究者
Morten Tange Kristensen PT, PhD
Senior researcher, PT, Phd
Hvidovre University Hospital