INRA, Unité de Nutrition Humaine (UNH), Université Clermont Auvergne, CRNH Auvergne, Clermont-Ferrand, France.
Service de Médecine Physique et Réadaptation, Centre Hospitalier Universitaire Clermont-Ferrand, Clermont-Ferrand, France.
BMJ Open. 2017 Nov 12;7(11):e017307. doi: 10.1136/bmjopen-2017-017307.
Surgery is the standard curative treatment for lung cancer but is only possible in patients with local tumour and preserved exercise capacity. Improving fitness before surgery can reduce postoperative complications and mortality. However, preoperative rehabilitation remains difficult to implement for several reasons. We aim to investigate the effectiveness of an intensive 3-week home-based preoperative exercise training programme on hospital discharge ability, postoperative complications and physical performance in patients with chronic obstructive pulmonary disease (COPD) who are eligible for lung cancer surgery.
We designed a multicentre randomised controlled trial. The randomisation sequence will be generated and managed electronically by a research manager independent of assessments or interventions. We will recruit 90 patients with COPD and a diagnosis of lung cancer from four university hospitals. The rehabilitation group (R group) will receive a standardised preoperative home exercise programme for 3 weeks, combining both high-intensity training and usual physical therapy. The R group will perform 15 training sessions over 3 weeks on a cycloergometer. A physical therapist experienced in pulmonary rehabilitation will visit the patient at home and supervise one session a week. The R group will be compared with a control group receiving preoperative usual physical therapy only. The primary outcome will be hospital discharge ability assessed with a 10-item list. Secondary outcomes will be postoperative course (complication rate and mortality) as well as pulmonary function, exercise capacity and quality of life assessed 1 month before and the day before surgery.
This protocol has been approved by the French health authority for research (2016-A00622-49) and the research ethics committee/institutional review board (AU1267). Adverse events that occur during the protocol will be reported to the principal investigator. The results will be published in an international peer-reviewed journal.
NCT03020251.
手术是治疗肺癌的标准疗法,但仅适用于局部肿瘤且运动能力未受损的患者。手术前提高体能可以降低术后并发症和死亡率。然而,由于多种原因,术前康复仍然难以实施。我们旨在研究一项为期 3 周的强化家庭术前运动训练计划对适合肺癌手术的慢性阻塞性肺疾病(COPD)患者出院能力、术后并发症和身体表现的有效性。
我们设计了一项多中心随机对照试验。随机序列将由一名独立于评估或干预的研究经理以电子方式生成和管理。我们将从四家大学医院招募 90 名 COPD 合并肺癌诊断的患者。康复组(R 组)将接受为期 3 周的标准化家庭术前运动方案,包括高强度训练和常规物理治疗。R 组将在 3 周内使用自行车测力计进行 15 次训练。一位有经验的肺部康复物理治疗师将家访并每周监督一次。R 组将与仅接受术前常规物理治疗的对照组进行比较。主要结局将使用 10 项清单评估出院能力。次要结局将包括术后过程(并发症发生率和死亡率)以及 1 个月前和手术前一天评估的肺功能、运动能力和生活质量。
该方案已获得法国卫生当局(2016-A00622-49)和研究伦理委员会/机构审查委员会(AU1267)的批准。协议期间发生的不良事件将报告给主要研究者。结果将发表在国际同行评议期刊上。
NCT03020251。