Effects of Preoperative Rehabilitation in Patients Resected for Lung Cancer

Study Overview
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Brief Summary
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This randomized controlled trial will evaluate the effect of a preoperative rehabilitation program at home in patients resected for lung cancer, comparing a control group (C group) receiving only chest physiotherapy and a rehabilitation group (R group) receiving both a training program at home and chest physiotherapy

Official Title
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Effects of Preoperative Rehabilitation in Patients Resected for Lung Cancer

Conditions
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Lungcancer

Intervention / Treatment
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* Other: preoperative chest physiotherapy
* Other: preoperative rehabilitation program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed for lung cancer (or highly suspicious for cancer tumor) eligible for resection surgery (lobectomy or pneumonectomy) Age > 18 years Presence of Chronic Obstructive Pulmonary Disease (COPD) stages 2-4 of Gold (forced expiratory volume (FEV )/ forced vital capacity (FVC) <70%, FEV <80% of predicted) and Exertional dyspnea stage MMRC (Medical Research Council) > 1 Patients must provide written consent Member of social security scheme Exclusion Criteria: Patients refusing to participate COPD stage 1 Gold (VEMS >= 80% of the theoretical value) Presenting an operating contraindication during the initial maximal exercise test Presenting cardiac or vascular contraindication to achieve the readaptation program Patient living alone at home Patient with ventilatory assistance at home (oxygen therapy or noninvasive ventilation (NIV)) With exercise hypoventilation (PaCO2 >45 mmHg) Cognitive difficulty unable major pregnancy, patients deprived of liberty by a court or administrative decision

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group (C group)<br>patient will receive preoperative chest physiotherapy (standard supportive care) | Other: preoperative chest physiotherapy<br>* preoperative chest physiotherapy : 5 sessions per week during 3 weeks<br>|
| Experimental: rehabilitation group (R group)<br>patient will receive preoperative chest physiotherapy and a preoperative rehabilitation program at home (exercise training) | Other: preoperative chest physiotherapy<br>* preoperative chest physiotherapy : 5 sessions per week during 3 weeks<br>Other: preoperative rehabilitation program<br>* exercise training at home : 5 sessions per week during 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay after resection for lung cancer | the date of discharge will be the real day of discharge from surgery department or the day where the patient will be medically considered as outgoing | time from the date of the surgery (Day 0) until the date of discharge (Day n) (assessed up to 56 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of complications |  | during the stay in the surgery department or the intensive care unit (up to 56 days) | 
| peak oxygen consumption | evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4). evaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5) | evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2: during the week before the date of surgery (week 5) | 
| 6 minutes walking distance | evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4). evaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5) | evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2: during the week before the date of surgery (week 5) | 
| maximal voluntary quadriceps strength | evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4). evaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5) | evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2: during the week before the date of surgery (week 5) | 
| maximal inspiratory and expiratory strength | evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4). evaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5) | evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2: during the week before the date of surgery (week 5) | 
| real length of stay | the real day of discharge from surgery department | between the first postoperative day (Day 1) and the real discharge date (up to 56 days) | 
| body composition (bioimpedancemetry) | evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4). evaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5) | evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2: during the week before the date of surgery (week 5) | 
| oxidative adaptations of the muscle | optional ancillary study on quadricipal and intercostal muscle biopsies. | evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2 after intervention : at the date of surgery (during the surgical time at Day 0 week 6) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preoperative rehabilitation program, chest physiotherapy, lung cancer resection