Clinical trial NCT06202222: Interest of Intensive Postoperative Rehabilitation Following Minimally Invasive Lung Resection
Official title: Interest of Intensive Postoperative Rehabilitation Following Minimally Invasive Lung Resection: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Cancer
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

- 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 15.
* 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.

Primary outcomes:
measure: Number of chair lifts at the scheduled visit 30 days after surgery
timeFrame: 30 days after surgery
Secondary outcomes:
measure: number of days between surgery and discharge patient
timeFrame: 30 days after surgery
measure: chair rise test
timeFrame: 7 days after surgery
measure: number of complication GRADE II of clavien dindo classification
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Valenciennes
country: France
facility: Valenciennes, Hospital
state: Hauts De France
city: Caen
country: France
facility: CAEN, university Hospital
state: Normandie
city: Rouen
country: France
facility: Rouen, University Hospital
state: Normandie
Study officials:
References: