Pfirrmann Daniel, Tug Suzan, Brosteanu Oana, Mehdorn Matthias, Busse Martin, Grimminger Peter P, Lordick Florian, Glatz Torben, Hoeppner Jens, Lang Hauke, Simon Perikles, Gockel Ines
Department of Sports Medicine, Disease Prevention and Rehabilitation, Johannes Gutenberg-University of Mainz, Albert-Schweitzer-Str. 22, D-55128, Mainz, Germany.
Clinical Trial Centre Leipzig, University Leipzig, Leipzig, Germany.
BMC Cancer. 2017 Jun 14;17(1):413. doi: 10.1186/s12885-017-3400-8.
Patients undergoing surgery for esophageal cancer have a high risk for postoperative deterioration of lung function and pulmonary complications. This is partly due to one-lung ventilation during thoracotomy. This often accounts for prolonged stay on intensive care units, delayed postoperative reconvalescence and reduced quality of life. Socioeconomic disadvantages can result from these problems. Physical preconditioning has become a crucial leverage to optimize fitness and lung function in patients scheduled for esophagectomy, in particular during the time period of neoadjuvant therapy.
METHODS/STUDY DESIGN: We designed a prospective multicenter randomized-controlled trial. The objective is to evaluate the impact of an internet-based exercise program on postoperative respiratory parameters and pneumonia rates in patients with Barrett's carcinoma scheduled for esophagectomy. Patients are randomly assigned to either execute internet-based perioperative exercise program (iPEP), including daily endurance, resistance and ventilation training or treatment as usual (TAU). During neoadjuvant therapy and recovery, patients in the intervention group receive an individually designed intensive exercise program based on functional measurements at baseline. Personal feedback of the supervisor with customized training programs is provided in weekly intervals.
This study will evaluate if an intensive individually adapted training program via online supervision during neoadjuvant therapy will improve cardiorespiratory fitness and reduce pulmonary complications following esophagectomy for Barrett's cancer.
NCT02478996 , registered 26 May 2015.
接受食管癌手术的患者术后肺功能恶化及肺部并发症风险较高。部分原因是开胸手术期间的单肺通气。这常常导致在重症监护病房停留时间延长、术后恢复延迟以及生活质量下降。这些问题可能会造成社会经济方面的不利影响。身体预适应已成为优化计划接受食管切除术患者的健康状况和肺功能的关键手段，尤其是在新辅助治疗期间。
方法/研究设计：我们设计了一项前瞻性多中心随机对照试验。目的是评估基于互联网的运动计划对计划接受食管切除术的巴雷特癌患者术后呼吸参数和肺炎发生率的影响。患者被随机分配至执行基于互联网的围手术期运动计划（iPEP），包括每日耐力、阻力和通气训练，或接受常规治疗（TAU）。在新辅助治疗和恢复期间，干预组患者根据基线功能测量结果接受个性化设计的强化运动计划。每周提供主管的个人反馈及定制训练计划。
本研究将评估在新辅助治疗期间通过在线监督进行的强化个体化适应性训练计划是否会改善巴雷特癌食管切除术后的心肺适能并减少肺部并发症。
NCT02478996，于2015年5月26日注册。
