Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Respiratory Rehabilitation at Home vs in the Center for Patients With Chronic Obstructive Pulmonary Disease: Efficacy, Preferences and Costs
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.
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.
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