Postoperative Rehabilitation in Operation for LUng CAncer (PROLUCA) - A Randomized Clinical Trial With Blinded Effect Evaluation
试验速览
- 阶段
- 不适用
- 入组人数
- 235
- 试验地点
- 2
- 主要终点
- A change in maximum oxygen consumption
研究概览
简要总结
Purpose The purpose of the PROLUCA study is to investigate the efficacy of early postoperative rehabilitation in a non-hospital setting in patients with operable lung cancer, with focus on exercise training.
Design/Methods
One hundred and twenty-eight (n=128) participants (64 patients/study arm) with Non-Small Cell Lung Cancer (NSCLC), stage I-IIIa, referred for surgery, will be randomized to one of the following two groups:
- Early postoperative rehabilitation initiated as early as two weeks after surgery
- Postoperative rehabilitation initiated 14 weeks after surgery Intervention The intervention consists of a supervised group exercise program comprising resistance and cardiorespiratory exercise two hours weekly for 12 weeks combined with individual counseling.
The primary study endpoint is Maximal oxygen uptake measured by a VO2peak test (direct measurement) Secondary endpoints include: Six minutes walk distance (6MWD), One-repetition-maximum (1RM) Patient-reported outcomes (PROs) on health related quality of life, fatigue, depression, lifestyle, postoperative complications, hospitalization time, sick leave, work status and survival.
Results The results of PROLUCA will identify the optimal timing of postoperative rehabilitation in NSCLC patients with focus on increasing physical capacity and health related quality of life and reducing the side effects from the treatment of the cancer disease.
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
- Triple (Care Provider, Investigator, 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
- •All subjects are assigned for curative lung cancer surgery at Department of Cardiothoracic Surgery RT at Copenhagen University Hospital (Rigshospitalet)
- •Performance status 0-2 (WHO)
- •Living in the City of Copenhagen or surrounding Municipalities
- •Ability to read and understand Danish
- •Approval by primary surgeon
排除标准
- •Presence of metastatic disease or surgical inoperability. Diagnosis of Lung Cancer not verified by histological diagnosis.
- •Decompensated heart failure, severe aortic stenosis, uncontrolled arrhythmia, acute coronary syndrome
- •Contraindications to maximal exercise testing as recommended by the American Thoracic Society and exercise testing guidelines for cancer patients
结局指标
主要结局
A change in maximum oxygen consumption
时间窗: A change in maximum oxygen consumption from baseline to post intervention (for group one, the experimental group, it is approximately 14 weeks after the operation and for group two it is approximately 26 weeks after the operation)
A change in maximum oxygen consumption from baseline to post interventon, measured by a VO2peak, evaluated by an incremental test using an electromagnetically braked cycle ergometer
次要结局
- Patient Reported outcomes(Baseline, post intervention, follow-up at 26 and 52 weeks after surgery)
- Lung capacity(Baseline, two and 8 weeks after surgery. post intervention, follow-up at 26 and 52 weeks after surgery)
- Muscle strength chest and leg press(Baseline, post intervention, follow-up at 26 and 52 weeks after surgery)
- Six minutes walk distance(Baseline, two and 8 weeks after surgery. post intervention, follow-up at 26 and 52 weeks after surgery)
- A change in maximum oxygen consumption(A change in maximum oxygen consumption from baseline to 52 weeks after operation)
研究者
Jesper Holst Pedersen
MD, MrDSci
Rigshospitalet, Denmark