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临床试验/NCT06202222
NCT06202222招募中不适用

Interest of Intensive Postoperative Rehabilitation Following Minimally Invasive Lung Resection: A Randomized Controlled Study

University Hospital, Rouen6 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2024年9月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
184
试验地点
6
主要终点
Number of chair lifts at the scheduled visit 30 days after surgery

研究概览

简要总结

For patients diagnosed with non-small cell lung cancer (NSCLC), lung resection surgery remains the gold standard for curative treatment. This scheduled operation is associated with significant morbidity, particularly in individuals with impaired cardio-respiratory function. Therefore, patient optimization is paramount. The process begins prior to surgery with preoperative rehabilitation, commonly referred to as "prehabilitation," serving as the foundation for various Enhanced Recovery After Surgery programs. The training methods employed in these programs bear similarity to rehabilitation programs designed for patients with chronic obstructive pulmonary disease (COPD).

Postoperatively, patients undergoing thoracic surgery partake in daily physiotherapy sessions, aiming to optimize the postoperative period, minimize the respiratory impact of surgery, and reduce the length of hospital stay. However, this treatment is not currently standardized and primarily involves early mobilization, including walking, and respiratory physiotherapy. Our focus is on the intensity and methods of this postoperative rehabilitation.

There is limited literature on effective early rehabilitation in the immediate postoperative period, and existing studies suggest no adverse events associated with postoperative training. Therefore, our objective is to assess whether combining endurance training with standard physiotherapy (walking and respiratory physiotherapy) enhances the functional capacity of individuals undergoing lung surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • Patients requiring surgery for diagnosed or undergoing diagnosis of lung cancer.
  • Patients in need of major lung resection through a minimally invasive approach.
  • Patients capable of performing the chair rise test.

排除标准

  • - Contraindications to cyclo-ergometry: Deep vein thrombosis in a lower limb. Patients with one or both lower limbs amputated. Rheumatological pathology, trauma, or previous surgery in the lower limb, pelvis, or spine, resulting in limited joint amplitude or strict immobilization.
  • Dermatological conditions with severe lesions preventing prolonged sitting on a bicycle.
  • Glasgow score less than
  • Patients who have not undergone pulmonary resection by minimally invasive surgery.
  • Patients hospitalized outside the thoracic surgery department before the first post-operative visit with the physiotherapist on Day 0.

结局指标

主要结局

Number of chair lifts at the scheduled visit 30 days after surgery

时间窗: 30 days after surgery

number of chair lifts

次要结局

  • number of complication GRADE II of clavien dindo classification(30 days after surgery)
  • number of days between surgery and discharge patient(30 days after surgery)
  • chair rise test(7 days after surgery)

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (6)

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