Interest of Intensive Postoperative Rehabilitation Following Minimally Invasive Lung Resection

NCT06202222 | Recruiting

• 1 other identifier: 2020/0427/HP
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 3

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

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

  number of chair lifts

  30 days after surgery

Secondary Outcomes (3)

• number of days between surgery and discharge patient

  30 days after surgery

• chair rise test

  7 days after surgery

• number of complication GRADE II of clavien dindo classification

  30 days after surgery

Study Arms (2)

standard rehabilitation

NO INTERVENTION

standard rehabilitation and cycloergometer

EXPERIMENTAL

Other: rehabilitation

Interventions

rehabilitation OTHER

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.

standard rehabilitation and cycloergometer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (3)

Valenciennes, Hospital

Valenciennes, Hauts-de-France, 59322, France

RECRUITING

CAEN, university Hospital

Caen, Normandy, 14033, France

RECRUITING

Rouen, University Hospital

Rouen, Normandy, 76 031, France

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Jean-Marc BASTE, PhD

CONTACT

+33 2 32 88 87 04; jean-marc.baste@chu-rouen.fr

Fairuz BOUJIBAR, PhD

CONTACT

+33 2 32 88 89 90; fairuz.biujibar@chu-rouen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 11, 2024
• Study Start: September 9, 2024
• Primary Completion (Estimated): May 9, 2027
• Study Completion (Estimated): May 9, 2027
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)