Short-Term Pre-operative Rehabilitation for Patients With Lung Cancer: A Randomized Trial.
For patients with non small cell lung cancer (NSCLC), lung resection surgery is the only
treatment option which increases survival. However, surgery can not be offered to those with
significant heart disease, limited lung function or lacking physical fitness. These are all
major risk factors for operative outcome. Cardio-pulmonary exercise testing (CPET) allows
direct measurement of aerobic physical fitness through maximal oxygen consumption (VO2 max).
A recent update of professional guidelines (ERS/ESTS) has emphasized the importance of CPET
in preoperative risk stratification of patients with NSCLC. Interestingly, intensive
physical training has been shown to increase aerobic fitness in animals and healthy subjects
whereas improvement of VO2 max has been observed in preliminary pilot studies conducted in
patients undergoing surgery for NSCLC. However, the net effect of short-term, intensive,
outpatient rehabilitation on clinically relevant outcomes, such as major post-operative
cardio-pulmonary complications, as well as physiological outcomes is unknown.
Objectives:
1. To assess the physiological effect of 3 weeks of intensive physical training in
patients eligible for NSCLC surgery.
2. To assess the effect of physical training on post-operative outcomes.
3. To identify the clinical variables, laboratory tests and specific gene polymorphisms
(SNPs) associated with these outcomes.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
A composite endpoint of respiratory or cardiac or other post-operative complications requiring therapy
Respiratory Pneumonia Atelectasis (requiring bronchoscopy or positive expiratory pressure) Mechanical ventilation >12 hours Unplanned re-intubation Acute lung injury or acute respiratory distress syndrome (ALI/ARDS) Cardiac Acute heart failure Myocardial infarction or acute coronary syndrome Arrhythmia Other Delirium, mental status changes Stroke or transient ischemic accident 30-day mortality Acute renal failure (doubling of baseline pre-operative value) Surgical site infection
30 days after surgery
No
Switzerland: Commission Centrale d'éthique
Protocole 09-263
NCT01258478
December 2010
January 2014
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