Clinical trial NCT03020251: Effects of Preoperative Rehabilitation in Patients Resected for Lung Cancer
Official title: Effects of Preoperative Rehabilitation in Patients Resected for Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lungcancer
Keywords: preoperative rehabilitation program
chest physiotherapy
lung cancer resection
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: 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

Primary outcomes:
measure: Hospital length of stay after resection for lung cancer
timeFrame: time from the date of the surgery (Day 0) until the date of discharge (Day n) (assessed up to 56 days)
Secondary outcomes:
measure: the number of complications
timeFrame: during the stay in the surgery department or the intensive care unit (up to 56 days)
measure: peak oxygen consumption
timeFrame: 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)
measure: 6 minutes walking distance
timeFrame: 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)
measure: maximal voluntary quadriceps strength
timeFrame: 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)
measure: maximal inspiratory and expiratory strength
timeFrame: 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)
measure: real length of stay
timeFrame: between the first postoperative day (Day 1) and the real discharge date (up to 56 days)
measure: body composition (bioimpedancemetry)
timeFrame: 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)
measure: oxidative adaptations of the muscle
timeFrame: 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)
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont Ferrand, Gabriel Montpied, service de médecine du sport et explorations fonctionnelles,
city: Clermont-Ferrand
country: France
facility: Centre de Recherche en Nutrition Humaine
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Grenoble
country: France
facility: CHU Grenoble, Hôpital Michallon
city: Lyon
country: France
facility: Hospices Civiles de Lyon, groupement hospitalier Est, Hopital Louis Pradel
city: Saint Etienne
country: France
facility: CHU Saint-Etienne, CHU Hopital Nord
Study officials:
affiliation: Centre Jean Perrin
name: Marc FILAIRE, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Laurent H, Galvaing G, Thivat E, Coudeyre E, Aubreton S, Richard R, Kwiatkowski F, Costes F, Filaire M. Effect of an intensive 3-week preoperative home rehabilitation programme in patients with chronic obstructive pulmonary disease eligible for lung cancer surgery: a multicentre randomised controlled trial. BMJ Open. 2017 Nov 12;7(11):e017307. doi: 10.1136/bmjopen-2017-017307.