Effects of Preoperative Rehabilitation in Patients Resected for Lung Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 6
- Primary Endpoint
- Hospital length of stay after resection for lung cancer
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
control group (C group)
patient will receive preoperative chest physiotherapy (standard supportive care)
Intervention: preoperative chest physiotherapy (Other)
rehabilitation group (R group)
patient will receive preoperative chest physiotherapy and a preoperative rehabilitation program at home (exercise training)
Intervention: preoperative chest physiotherapy (Other)
rehabilitation group (R group)
patient will receive preoperative chest physiotherapy and a preoperative rehabilitation program at home (exercise training)
Intervention: preoperative rehabilitation program (Other)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- real length of stay(between the first postoperative day (Day 1) and the real discharge date (up to 56 days))