Effect of a Home-based, Supervised Prehabilitation With Wearable Technology for Patients With Non-small Cell Lung Cancer Before Lung Resection: a Single-arm, Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Exercise capacity
研究概览
简要总结
To explore the safety and compliance of a wearable telemedicine device that can receive basic vital signs in real time, and its active supervision mode with real-time adjustment of exercise prescription for preoperative prehabilitation exercises in patients at home; and to evaluate the effectiveness of preoperative prehabilitation exercises in a telemedicine active supervision mode in patients undergoing thoracoscopic lung tumour resection, taking into account the patient's cardiopulmonary exercise test, postoperative complications and quality of life scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Capacity to give informed consent.
- •Are able to tolerate surgery (i.e., segmentectomy, lobectomy) as indicated by standard clinical pre-op evaluation, including pulmonary function tests and cardiopulmonary exercise testing.
- •Patients who can use a smartphone application.
- •Patients who are diagnosed of stage I or II Non-small-cell lung carcinoma (NSCLC) diagnosis, with or without pre-operative histologic confirmation.
- •Patients who can perform an exercise program for at least 4 weeks from the first visit to the preoperative clinic to elective surgery.
排除标准
- •Known contraindication for cardiopulmonary exercise testing.
- •Patients who have a major medical or psychiatric disorder that is expected to affect exercise.
- •Pregnancy or lactating women.
研究组 & 干预措施
single arm
4 weeks of multimodal pre-rehabilitation
干预措施: Multimodal prehabilitation (Behavioral)
结局指标
主要结局
Exercise capacity
时间窗: Baseline, 4 weeks after prehabilitation exercise
Exercise testing on a cycloergometer(VO2 max)
Study feasibility
时间窗: Baseline, 4 weeks after prehabilitation exercise
Assessed by the following indicators: study participation rate, screening and enrollment rates, intervention completion rate, number of completed exercise days, wearable-device wearing days and wearing rate, analyzable activity days, paper-log completion, app-based electronic-log completion, alert generation and closure, intervention discontinuation, adverse events, and serious adverse events
次要结局
- Change in grip-strength(Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery)
- Forced expiratory volume in 1 s(FEV1)(Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery)
- Forced vital capacity (FVC)(Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery)
- Acceptance of technology(4 weeks of prehabilitation exercise)
- Change in quality of life(Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery)
- Adherence to exercise(4 weeks of prehabilitation exercise)
- Length of stay in hospital(Up to 30 postoperative days)
- Post-operative complications(From day of surgery to 30-days afterwards)
- Pre-post changes in cardiopulmonary exercise testing(Baseline, 4 weeks of prehabilitation exercise)
- Post-operative complications(30-days after surgery (T4))
- Moderate to vigorous physical activity(Baseline, 4 weeks of prehabilitation exercise)