Personalized Trimodal Prehabilitation for Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 128
- 试验地点
- 3
- 主要终点
- Postoperative morbidity rate by Clavien-Dindo
研究概览
简要总结
Prehabilitation has been demonstrated to be an effective strategy to improve outcomes in patients undergoing some of the abdominal operations. It may increase the physical capacity of the patient, improve postoperative quality of life and even decrease the postoperative morbidity. Currently, the most effective strategy seems to be a trimodal prehabilitation which includes: 1) Nutritional support 2) Psychological support and 3) Physical training.
详细描述
This study will investigate personalized trimodal prehabilitation for patients undergoing gastrectomy for gastric cancer.
Prehabilitation group:
Patients will undergo 6 Minutes Walking Test (6-MWT), spiroergometry (VO2 max; AT), a grip strength test, a timed Up & Go (TUG) test, 10 m sprint test and sit to stand test before and after prehabilitation. The trimodal intervention will involve:
- Nutritional intervention: The dietetic physician will perform physical examination and evaluation of the nutritional status to provide individualized care to each patient. Patients will receive personalized recommendations for the prevention or correction of malnutrition.
- Psychological intervention: Patients will undergo consultation by specialized onco-psychologist. The anxiety and depression level will be evaluated by HAD score and patients will be trained to perform techniques, such as relaxation to reduce and manage anxiety on at home basis.
The psychologist also will enhance patients' motivation to comply with the exercise and nutritional aspects of the intervention. 3. Exercise intervention: Patients will be consulted by PM&R physicians and physiotherapists and personalized exercise plans will be developed according to the results of 6MWT, AT and VO2peak. Exercises will focus on skeletal muscles and cardiopulmonary function training and the exercises feasible at home basis will be selected. All patients will undergo three supervised training sessions to learn the correct exercise techniques.
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
- •Patient ≥ 18 years old
- •Patient agrees to participate in a clinical study
- •Patient requires surgical treatment for gastric cancer
排除标准
- •Patient requiring surgical treatment for recurrent gastric cancer
- •Patient condition not allowing to postpone surgery for at least 4 weeks
- •Patients physical or mental condition which will not allow the patient to participate in prehabilitation program
结局指标
主要结局
Postoperative morbidity rate by Clavien-Dindo
时间窗: At 90 days postoperatively
次要结局
- Quality of Life by EORTC questionnaires(Baseline, pre-surgery, 3, 6 and 12 months after surgery)
- Physical status by grip strength test(Baseline, pre-surgery, 3, 6 and 12 months after surgery)
- Nutritional status by albumin level(Baseline, pre-surgery, 3, 6 and 12 months after surgery)
- Physical status by 6 minutes walk test(Baseline, pre-surgery, 3, 6 and 12 months after surgery)
- Physical status by International Physical Activity Questionnaire (IPAQ)(Baseline, pre-surgery, 3, 6 and 12 months after surgery)
- Percentage of patients reaching the complete oncological treatment fixed in a multidisciplinary tumour board (including preoperative chemotherapy, surgery and postoperative chemotherapy)(12 months after surgery)
- Physical status by the sit to stand test(Baseline, pre-surgery, 3, 6 and 12 months after surgery)
- Postoperative mortality rate(At 30 and 90 days postoperatively)
- Physical status by the timed up&go test(Baseline, pre-surgery, 3, 6 and 12 months after surgery)
- Psychological status by Hospital Anxiety and Depression Scale (HADS).(Baseline, pre-surgery, 3, 6 and 12 months after surgery)
- Physical status by Spiroergometry(Baseline, pre-surgery, 3, 6 and 12 months after surgery)