Physsurg - a Controlled Randomized Trial on the Effect of Physical Activity in Relation to Outcome After Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 761
- 试验地点
- 2
- 主要终点
- Recovery measured as physical recovery measured in questionnaire
研究概览
简要总结
This study will compare the outcome after surgery between a group of patients that receives instructions for prehabilitation training and one group that received standard treatment.
详细描述
The aim of this study is to investigate whether a training program with intensified physical activity prior to and after a surgical procedure reduces the surgical-related postoperative recovery time, hospital stay, sick leave and complication rate.
A secondary aim is to investigate the effect of a training program with pre- and post- operative PA on the rate of resumption of QoL and normal physical function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed colorectal cancer and a planned surgical procedure
排除标准
- •HIPEC surgery, not able to give informed consent or understand the intervention
研究组 & 干预措施
Pre and postoperative exercise
The intervention is prehabilitation preoperatively and physical training postoperatively. During the hospital stay both groups will be treated in the same manner.
Preoperative intervention:
One half hour of exercise daily added to the existing daily exercise routine. The level of exercise should produce shortness of breath but the patient should be able to talk without much effort.
Inspiratory muscle training. Thirty breaths x two twice daily. Postoperative intervention is mainly the same as preoperatively.
干预措施: Physical activity (Other)
Control
Standard treatment with one exception, patients will fill in a physical activity diary
结局指标
主要结局
Recovery measured as physical recovery measured in questionnaire
时间窗: 4-6 weeks
次要结局
- Postoperative pain measured with Brief Pain Inventory-Short form(4 weeks)
- Health economic analysis(4 weeks)
- Complications according to Clavien-Dindo(within 90 days)
- QoL measured using EQ-5D(4-6 weeks and 1 year)
- Psychological recovery measured in a questionnaire, patient reported(4-6 weeks and 1 year post-operatively)
- QoL measured using a specifically developed instrument for this study(4-6 weeks and 1 year)
- Total time of hospital stay(1 year)
- Mortality(3 and 5 years)
- Re-admissions(1 year)
- Reoperations(1 year)
- Recovery measured as time back to work(1 year)
- QoL measured using SF-36(4-6 weeks and 1 year)
- IGF-1 and IGFBP-3(4 weeks postopeartively)
- Postoperative pain measured with Brief Pain Inventory-Short form(12 months)
- Health economic analysis(12 months)
研究者
Eva Haglind, MD, PhD, professor
Consultant Surgeon, Professor
Sahlgrenska University Hospital