Respiratory Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease

Last updated: August 24, 2020
Sponsor: University Hospital, Lille
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03453606
2017_08
2017-A02393-50
PREPS-16-249
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:According to HAS recommendations, SPLF, ERS / ATS (3) (18) (19) can beincluded any patient, over 18 years old, with stage II - III - IV COPD presenting disablingdyspnoea in activities of daily living, and / or in the course of acute exacerbation ofCOPD (EABPCO), with no other respiratory pathology diagnosed.

Exclusion

Exclusion Criteria: According to the recommendations, HAS, SPLF, ERS / ATS will not be included any patienthaving :

  • co-morbidities including unstabilized cardiovascular disease,

  • significant cognitive disorders: patients with a history of pathologiesneurodegenerative with loss of mental faculties (example: Alzheimer)

  • psychiatric disorders: patients with impaired judgment and perception

  • neurological or orthopedic disorders that do not allow the realization of physicalactivities Also, will not be included, the patient (s):

  • waiting for lung transplantation,

  • pregnant or nursing,

  • in an emergency situation

  • unable to receive enlightened information,

  • unable to participate in the entire study,

  • not covered by the social security scheme,

  • refusing to sign the consent,

Study Design

Total Participants: 670
Study Start date:
October 24, 2018
Estimated Completion Date:
January 31, 2022

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.

Connect with a study center

  • CH de Béthune

    Béthune,
    France

    Active - Recruiting

  • Centre hospitalier de béthune

    Béthune,
    France

    Active - Recruiting

  • Hôpital Calmette, CHU

    Lille,
    France

    Active - Recruiting

  • CH de Loos

    Loos,
    France

    Active - Recruiting

  • CH Victor Provot, Roubaix

    Roubaix,
    France

    Active - Recruiting

  • CH de Tourcoing

    Tourcoing,
    France

    Active - Recruiting

  • CH de Wattrelos

    Wattrelos,
    France

    Active - Recruiting

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