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Clinical Trials/NCT03020251
NCT03020251
Completed
N/A

Effects of Preoperative Rehabilitation in Patients Resected for Lung Cancer

Centre Jean Perrin6 sites in 1 country90 target enrollmentMay 12, 2017

Overview

Phase
N/A
Intervention
preoperative chest physiotherapy
Conditions
Lungcancer
Sponsor
Centre Jean Perrin
Enrollment
90
Locations
6
Primary Endpoint
Hospital length of stay after resection for lung cancer
Status
Completed
Last Updated
last month

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

Registry
clinicaltrials.gov
Start Date
May 12, 2017
End Date
February 13, 2026
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centre Jean Perrin
Responsible Party
Sponsor

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,

Arms & Interventions

control group (C group)

patient will receive preoperative chest physiotherapy (standard supportive care)

Intervention: preoperative chest physiotherapy

rehabilitation group (R group)

patient will receive preoperative chest physiotherapy and a preoperative rehabilitation program at home (exercise training)

Intervention: preoperative chest physiotherapy

rehabilitation group (R group)

patient will receive preoperative chest physiotherapy and a preoperative rehabilitation program at home (exercise training)

Intervention: preoperative rehabilitation program

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))

Study Sites (6)

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