Interest of Intensive Postoperative Rehabilitation Following Minimally Invasive Lung Resection (IRPOL)
Interest of Intensive Postoperative Rehabilitation Following Minimally Invasive Lung Resection: A Randomized Controlled Study
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.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jean-Marc BASTE, PhD
- Phone Number: +33 2 32 88 87 04
- Email: jean-marc.baste@chu-rouen.fr
Study Contact Backup
- Name: Fairuz BOUJIBAR, PhD
- Phone Number: 65593 +33 2 32 88 89 90
- Email: fairuz.biujibar@chu-rouen.fr
Study Locations
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Hauts-de-France
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Valenciennes, Hauts-de-France, France, 59322
- Recruiting
- Valenciennes, Hospital
-
Contact:
- François MONTAGNE
- Phone Number: +33327140121
- Email: Montagne-f@ch-valenciennes.fr
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Normandy
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Caen, Normandy, France, 14033
- Recruiting
- CAEN, university Hospital
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Contact:
- Maxime HENDRYNDRICKX
- Phone Number: +33231064450
- Email: heyndrickx-m@chu-rouen.fr
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Rouen, Normandy, France, 76 031
- Recruiting
- Rouen, University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: standard rehabilitation
|
|
|
Experimental: standard rehabilitation and cycloergometer
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of chair lifts at the scheduled visit 30 days after surgery
Time Frame: 30 days after surgery
|
number of chair lifts
|
30 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
number of days between surgery and discharge patient
Time Frame: 30 days after surgery
|
30 days after surgery
|
|
chair rise test
Time Frame: 7 days after surgery
|
7 days after surgery
|
|
number of complication GRADE II of clavien dindo classification
Time Frame: 30 days after surgery
|
30 days after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/0427/HP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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