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Recruiting NCT06202222

Interest of Intensive Postoperative Rehabilitation Following Minimally Invasive Lung Resection

No phase Interventional Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: rehabilitation.
Who it may be relevant to
Registry conditions: Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other rehabilitation
    The patient undergoes a daily session on the cycloergometer (Am3i Ergometer). The patient is instructed to pedal at a heart rate ranging from 60% to 80% of their maximum heart rate (calculated as 220 minus their age) for a duration of 20 minutes. These sessions can be conducted with oxygen therapy for patients dependent on oxygen. The sessions are maintained until the patient is discharged from the department.

Primary outcome measures

  • Number of chair lifts at the scheduled visit 30 days after surgery [Time frame: 30 days after surgery]
Secondary outcome measures (3)
  • number of days between surgery and discharge patient [Time frame: 30 days after surgery]
  • chair rise test [Time frame: 7 days after surgery]
  • number of complication GRADE II of clavien dindo classification [Time frame: 30 days after 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 3 centers
  • Valenciennes, Hospital — Valenciennes
  • CAEN, university Hospital — Caen
  • Rouen, University Hospital — Rouen

Identifiers

NCT: NCT06202222 · 2020/0427/HP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗