Prehabilitation in Patients With Esophageal or Gastric Cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Retention rate
研究概览
简要总结
Objectives: The primary objective of this study is to assess the feasibility of a internet-based preoperative exercise program in patients with esophageal or gastric cancers. Secondary objectives are to evaluate the effects of this preoperative program on functional capacity, anxiety and depression, quality of life and fatigue Methods: This feasibility study will be conduct at University Hospital Saint-Luc in Brussels. Twenty patients with esophageal or gastric cancers will participate in internet-based program 3 sessions per week. Each session will combine aerobic and resistance training. Moreover, inspiratory muscle strengthening (IMT) will be performed daily. The researcher will conduct weekly telephone calls to educate and motivate subjects. Assessments will be performed at baseline, one day before surgery, 1 month and 3 months after surgery. The following parameters will be measured: functional capacity, quality of life, fatigue, anxiety and depression.
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
- •Diagnosis of esophageal cancer or gastric cancer requiring surgery
- •More than 18 years
- •Able to read, write and understand French or English
- •Time before surgery > 2 weeks
排除标准
- •Surgical emergency
- •Cognitive or neuropsychiatric diseases
- •Neuromuscular or orthopedic disorders limiting exercises
- •Cardiopulmonary disease contraindicating exercises
结局指标
主要结局
Retention rate
时间窗: At study completion (3 months after surgery)
Proportion of patients who complete the tele-prehabilitation and all assessments
Percentage of patients who experienced one or more adverse events
时间窗: At study completion (3 months after surgery)
Adverse events will be evaluated by listing adverse events that occur (e.g. fall, injury or exercise-related symptom)
Recruitment rate
时间窗: At study completion (3 months after surgery)
ratio of the number of the recruited patients to the number of eligible patients
Attendance
时间窗: At study completion (3 months after surgery)
(Number of completed sessions/Number of planned sessions) x 100
Program satisfaction
时间窗: At study completion (3 months after surgery)
Program satisfaction will be evaluated by a questionnaire including items about internet program
次要结局
- Change in anxiety and depression(Baseline, one day before surgery, 1 and 3 months after surgery)
- Change in quality of life(Baseline, one day before surgery, 1 and 3 months after surgery)
- Change in fatigue(Baseline, one day before surgery, 1 and 3 months after surgery)
- Change in functional capacity(Baseline, one day before surgery, 1 and 3 months after surgery)