Effects of Preoperative Rehabilitation in Patients Resected for Lung Cancer

NCT03020251 | Completed

• 1 other identifier: 2016-A00622-49
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 6

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

Conditions

Lungcancer

Keywords

preoperative rehabilitation program; chest physiotherapy; lung cancer resection

Outcome Measures

Primary Outcomes (1)

• Hospital length of stay after resection for lung cancer

  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

  time from the date of the surgery (Day 0) until the date of discharge (Day n) (assessed up to 56 days)

Secondary Outcomes (8)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

control group (C group)

ACTIVE COMPARATOR

patient will receive preoperative chest physiotherapy (standard supportive care)

Other: preoperative chest physiotherapy

rehabilitation group (R group)

EXPERIMENTAL

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

Other: preoperative chest physiotherapy; Other: preoperative rehabilitation program

Interventions

preoperative chest physiotherapy OTHER

preoperative chest physiotherapy : 5 sessions per week during 3 weeks

control group (C group); rehabilitation group (R group)

preoperative rehabilitation program OTHER

exercise training at home : 5 sessions per week during 3 weeks

rehabilitation group (R group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Jean Perrin: lead

Study Sites (6)

CHU Clermont Ferrand, Gabriel Montpied, service de médecine du sport et explorations fonctionnelles,

Clermont-Ferrand, 63000, France

Location

Centre de Recherche en Nutrition Humaine

Clermont-Ferrand, 63009, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

CHU Grenoble, Hôpital Michallon

Grenoble, 38700, France

Location

Hospices Civiles de Lyon, groupement hospitalier Est, Hopital Louis Pradel

Lyon, 69677, France

Location

CHU Saint-Etienne, CHU Hopital Nord

Saint-Etienne, 42055, France

Location

Related Publications (1)

• 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.

  PMID: 29133320 DERIVED

Study Officials

• Marc FILAIRE, Pr

  Centre Jean Perrin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: January 13, 2017
• Study Start: May 12, 2017
• Primary Completion: February 13, 2026
• Study Completion: February 13, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)