Preoperative Physical Activity Intervention in Patients Before Planned Liver Resection for Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Change of Oxgen consumption at anaerobic threshold :
研究概览
简要总结
The aim of this study is to assess the impact of preoperative physical activity on physical capacities of patients undergoing liver resection for primary or secondary liver cancer.
详细描述
The purpose of this study is to investigate the effects of a preoperative exercise program in patients with primary or secondary liver cancer undergoing hepatectomy. Preoperative exercise programs have been shown to be effective in other cancer populations, but have been poorly studied in patients with liver cancer. For these patients, it remains unclear what the optimal composition of such programs should be and how they should be delivered. Outcome measures in this study will include preoperative outcomes (oxygen consumption, quality of life, fatigue and physical activity level, anthropometric measures, plasma concentrations of hepatokines) and postoperative outcomes (length of hospital stay and postoperative complications).
After the study is explained and consent obtained, subjects will be tested on a submaximal exercise on cycloergometer with gas exchanges analysis and with pre and post blood test. Then, they will answer various questionnaires assessing physical activity, quality of life and fatigue.
Patients scheduled for liver resection will be randomized to one of two groups. The first group (experimental group) will be subdivided into two groups: interval training 1 and interval training 2, which differentiate themselves by two different intensities.The second group (control group) will receive standard care.
The prehabilitation program will last 6 weeks with 3 sessions per week and will consist in two interval training programs on a cycloergometer with two different intensities.
One month after surgery, peri and postoperative complications will be noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Men and women aged >18 years old.
- •Patients with primary liver cancer, biliary tract cancer, liver metastasis endorsed in the University Hospital of Besancon
- •No opposition of patients
- •Join a French social security or receiving such a scheme
排除标准
- •Legal incapacity or limited legal capacity
- •Patients being in the disqualification of another study or under the national register of volunteers
- •Patients unlikely to cooperate or anticipated low cooperation
- •Patients with a maximal oxygen consumption above 35 ml/min/kg
结局指标
主要结局
Change of Oxgen consumption at anaerobic threshold :
时间窗: 6 weeks
Oxygen consumption at anaerobic threshold will be assessed at baseline and at the end of the 6 weeks' program with a submaximal exercise performed on cycloergometer
次要结局
- Intensive care stay :(One month after surgery)
- Postoperative complications with the Dindo Clavien classification :(One month after surgery)
- Changes of Hepatokines plasmatic concentrations :(Comparison between plasmatic concentrations pre-exercise (day 1), post exercise (day 1) and at 6 weeks)
- Hepatokines plasmatic concentrations :(Comparison between plasmatic concentrations pre-exercise (day 1), post exercise (day 1) and at 6 weeks)
- Changes in Physical activity level :(Comparison between baseline, after the 6 weeks' program)
- Changes in Quality of life :(Comparison between baseline, after the 6 weeks' program)
- Changes in Fatigue :(Comparison between baseline, after the 6 weeks' program)
研究者
Célia Turco
Principal Investigator
Centre Hospitalier Universitaire de Besancon