Last updated on February 2019

A clinical trial sponsored by University Hospital, Lille for a research study for the treatment of Chronic Obstructive Lung Disease

Brief description of study

The aim of this clinical trial is to establish the non-inferiority of home-based respiratory rehabilitation compared to respiratory rehabilitation in center in terms of exercise tolerance as evaluated by the 6 minutes Stepper test..

This trial will also 1) evaluate the Medico-economic aspects of the home-based Respiratory rehabilitation versus respiratory Rehabilitation in center; 2) analyse the patient preferences between home-based respiratory rehabilitation and respiratory rehabilitation in center and 3) Compare home-based respiratory rehabilitation vs respiratory rehabilitation in center in terms of dyspnea, quality of life, anxiety and depression.

Detailed Study Description

The purpose of this study is to perform a comparative analysis of the clinical and medico-economic effectiveness of center-based RR versus home-based RR in the departments of Nord and Pas de Calais in France. All COPD patients eligible for RR and willing to participate in the study will be followed.

Patient preferences will be evaluated at inclusion. After presentation of both RR modalities, patients expressing a strong preference for one or other of the terms will be taken care of according to their wishes. Indifferent patients between the two RR modalities will be randomized.

This design is justified in the light of three cases:

  • It is impossible to evaluate blind intervention,
  • The effectiveness of RR depends on patient preferences,
  • Patients' adherence to the protocol is facilitated.

Clinical Study Identifier: NCT03453606

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