Effects of a Training Intervention After Thoracoabdominal Oesophagus 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
- 64
- 主要终点
- Degree of physical disability estimated by the Disability Rating Index (DRI)
研究概览
简要总结
This study evaluates the effect of a training intervention after thoracoabdominal resection of the oesophagus. Half of the patients scheduled for thoracoabdominal oesophagus surgery were randomized to an intervention group while the other half a control group.
详细描述
It is well known that thoracoabdominal oesophageal resection for cancer is a procedure with high risks for complications. Earlier trials have shown that respiratory restrictions persist after the operation as well as lower physical function, range of motion in the rib-cage and limitations in activities in daily living. There are, however, only two clinical studies that evaluate postoperative breathing exercises and none evaluating any other rehabilitation interventions.
In other types of extensive surgery that may affect mobility with trauma to muscles and bone structures in the thorax and thoracic spinal column, there is strong evidence that speaks for an active rehabilitation approach in favour of a less active one.
The intervention evaluated was a rehabilitation program including exercises to restore lung function, range of motion in the thoracic spine and shoulders and strength exercises for the back extensors, shoulders and legs.
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
- 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 scheduled for thoracoabdominal oesophageal resection
- •Ability to perform 90 W during a sub-maximal bicycle test
- •Ability to speak Swedish
排除标准
- •Serious untreated cardiac disease that may be critical
- •Musculoskeletal or neurological disease or trauma affecting respiration or range of motion in the rib cage
结局指标
主要结局
Degree of physical disability estimated by the Disability Rating Index (DRI)
时间窗: 3 months
12 items covering activities from dressing and going for walks to lifting heavy objects and exercising. The item responses were rated on visual analogue scales (0-100)
次要结局
- FVC (Forced Vital Capacity)(3 months)
- Pain in the neck, rib cage and shoulders (visual analogue scale)(3 months)
- Range of motion(3 months)
- Physical function (Time stand test and heel rise test)(3 months)
- Physical Activity (six-level scale)(3 months)
- Quality of Life by EORTC QLQ-C30(3 months)
- PEF (Peak Expiratory Flow)(3 months)
- FEV1 s(3 months)