- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03020251
Effects of Preoperative Rehabilitation in Patients Resected for Lung Cancer (Rexochir)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Clermont-Ferrand, France, 63011
- Centre Jean Perrin
-
Clermont-Ferrand, France, 63000
- CHU Clermont Ferrand, Gabriel Montpied, service de médecine du sport et explorations fonctionnelles,
-
Clermont-Ferrand, France, 63009
- Centre de Recherche en Nutrition Humaine
-
Grenoble, France, 38700
- CHU Grenoble, Hôpital Michallon
-
Lyon, France, 69677
- Hospices Civiles de Lyon, groupement hospitalier Est, Hopital Louis Pradel
-
Saint-Etienne, France, 42055
- CHU Saint-Etienne, CHU Hopital Nord
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control group (C group)
patient will receive preoperative chest physiotherapy (standard supportive care)
|
preoperative chest physiotherapy : 5 sessions per week during 3 weeks
|
|
Experimental: rehabilitation group (R group)
patient will receive preoperative chest physiotherapy and a preoperative rehabilitation program at home (exercise training)
|
preoperative chest physiotherapy : 5 sessions per week during 3 weeks
exercise training at home : 5 sessions per week during 3 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital length of stay after resection for lung cancer
Time Frame: 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
|
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
Time Frame: during the stay in the surgery department or the intensive care unit (up to 56 days)
|
during the stay in the surgery department or the intensive care unit (up to 56 days)
|
|
|
peak oxygen consumption
Time Frame: 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) |
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
Time Frame: 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) |
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
Time Frame: 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) |
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
Time Frame: 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) |
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
Time Frame: between the first postoperative day (Day 1) and the real discharge date (up to 56 days)
|
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)
Time Frame: 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) |
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
Time Frame: 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.
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marc FILAIRE, Pr, Centre Jean Perrin
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-A00622-49
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
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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