Interest of Intensive Postoperative Rehabilitation Following Minimally Invasive Lung Resection

Lung Cancer Clinical Trial

— IRPOL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06202222
• Other study ID #: 2020/0427:HP
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: September 1, 2026

Study information

• Verified date: November 2023
• Source: University Hospital, Rouen
• Contact: Jean-Marc BASTE, PhD
• Phone: +33 2 32 88 87 04
• Email: jean-marc.baste[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 184
• Est. completion date: September 1, 2026
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
France	CAEN, university Hospital	Caen	Normandie
France	Rouen, University Hospital	Rouen	Normandie
France	Valenciennes, Hospital	Valenciennes	Hauts De France

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of chair lifts at the scheduled visit 30 days after surgery	number of chair lifts	30 days after surgery
Secondary	number of days between surgery and discharge patient		30 days after surgery
Secondary	chair rise test		7 days after surgery
Secondary	number of complication GRADE II of clavien dindo classification		30 days after surgery