Lungcancer
Conditions
Keywords
preoperative rehabilitation program, chest physiotherapy, lung cancer resection
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
Interventions
preoperative chest physiotherapy : 5 sessions per week during 3 weeks
OTHERpreoperative rehabilitation program
exercise training at home : 5 sessions per week during 3 weeks
Sponsors
Centre Jean Perrin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 : 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) |
| 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) |
| 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) |
| 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) |
| 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 |
| 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) |
| 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. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORMarc FILAIRE, Pr
Centre Jean Perrin
Outcome results
None listed