Effects of Preoperative Rehabilitation in Patients Resected for Lung Cancer

Not Applicable

Recruiting

• Conditions: Lungcancer
• Interventions: Other: preoperative chest physiotherapy; Other: preoperative rehabilitation program

• Registration Number: NCT03020251
• Lead Sponsor: Centre Jean Perrin

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-20
• Study First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-13
• Study Start: 2017-05-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rehabilitation group (R group)	preoperative chest physiotherapy	patient will receive preoperative chest physiotherapy and a preoperative rehabilitation program at home (exercise training)
control group (C group)	preoperative chest physiotherapy	patient will receive preoperative chest physiotherapy (standard supportive care)
rehabilitation group (R group)	preoperative rehabilitation program	patient will receive preoperative chest physiotherapy and a preoperative rehabilitation program at home (exercise training)

Primary Outcome Measures

Name	Time	Method
Hospital length of stay after resection for lung cancer	time from the date of the surgery (Day 0) until the date of discharge (Day n) (assessed up to 56 days)	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

Secondary Outcome Measures

Name	Time	Method
the number of complications	during the stay in the surgery department or the intensive care unit (up to 56 days)
maximal voluntary quadriceps strength	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)	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)
body composition (bioimpedancemetry)	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)	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)
peak oxygen consumption	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)	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)
maximal inspiratory and expiratory strength	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)	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)
oxidative adaptations of the muscle	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)	optional ancillary study on quadricipal and intercostal muscle biopsies.
6 minutes walking distance	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)	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)
real length of stay	between the first postoperative day (Day 1) and the real discharge date (up to 56 days)	the real day of discharge from surgery department

Trial Locations

Locations (6)

CHU Clermont Ferrand, Gabriel Montpied, service de médecine du sport et explorations fonctionnelles,; 🇫🇷 Clermont-Ferrand, France

Centre de Recherche en Nutrition Humaine; 🇫🇷 Clermont-Ferrand, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

CHU Grenoble, Hôpital Michallon; 🇫🇷 Grenoble, France

Hospices Civiles de Lyon, groupement hospitalier Est, Hopital Louis Pradel; 🇫🇷 Lyon, France

CHU Saint-Etienne, CHU Hopital Nord; 🇫🇷 Saint Etienne, France