Respiratory Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: Home respiratory rehabilitation
* Other: Center respiratory rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:According to HAS recommendations, SPLF, ERS / ATS (3) (18) (19) can be included any patient, over 18 years old, with stage II - III - IV COPD presenting disabling dyspnoea in activities of daily living, and / or in the course of acute exacerbation of COPD (EABPCO), with no other respiratory pathology diagnosed. Exclusion Criteria: According to the recommendations, HAS, SPLF, ERS / ATS will not be included any patient having : co-morbidities including unstabilized cardiovascular disease, significant cognitive disorders: patients with a history of pathologies neurodegenerative 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 physical activities 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,

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: home group<br> | Other: Home respiratory rehabilitation<br>* Home care is individual (often with the spouse or the carer), during 1h30, one visit per week for 8 weeks, after completion of the educational diagnosis, under direct supervision of a member of the team, with continued physical activities in autonomy the others days of the week, according to a personalized action plan. No visit is scheduled in the pulmonologist, the general practitioner or in the rehabilitation center. The team includes pulmonologist, nurses, dietician, socio-medical beautician and a administrative assistant.<br>|
| Active Comparator: center group<br> | Other: Center respiratory rehabilitation<br>* In an outpatient setting, the course is performed in groups of 6 to 8 patients, during sessions from 3 to 7 am, under the direction of health professionals, 3 to 5 times a week, for 4 to 6 weeks, for a total of 20 to 24 sessions. Internally, patients come to complete hospitalization for 4 weeks. This duration can be modulated according to the evolution of the patients. Supervision is carried out by the entire team including pulmonologists, nurses, physiotherapists, psychologists, activity professors adapted physicists, dietician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline the 6 minutes Stepper test at 2 months | The 6 minutes stepper test (ST6), performed on a Stepper allows to analyze the number of strokes (or steps) performed in 6 minutes | At 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline the 6 minutes Stepper test at 6 and 12 months | The 6 minutes stepper test (ST6), performed on a Stepper allows to analyze the number of strokes (or steps) performed in 6 minutes | at 6 months, at12 months | 
| Percentage of patients expressing a preference marked for home-based respiratory rehabilitation or respiratory rehabilitation in center |  | Baseline | 
| Cost of interventions: respiratory rehabilitation in center or at home |  | At 12 months | 
| Change from Baseline COPD Assessment Test (CAT) at 2,6,12 months | The COPD assessment test (CAT) is a short questionnaire initially intended for assess quality of life and clinical impact of COPD | baseline, after RR (2 months); 6 months and12 months | 
| Change from Baseline Modified Medical Research Council (MMRC) Dyspnea Scale at 2,6,12 months | The scale measures a person's limitation base on a scale of 0-4 and uses the final value to determine how much disability is caused by shortness of breath.Five-option grading system called the Modified Medical Research Council (MMRC) Dyspnea Scale. | baseline, after RR (2 months); 6 months and12 months | 
| Change from Baseline Anxiety and Depression (HAD) at 2,6,12 months | To determine the levels of anxiety and depression that a COPD patients are experiencing | Baseline, after RR (2 months); 6 months and12 months | 
| EPICES score | EPICES score (Assessment of the precariousness and health inequalities in the Health Examination Centers, French) is an individual indicator of precariousness ,Self-administered questionnaire,quantify the level of social vulnerability and precariousness. It ranges from zero (no vulnerability) to 100 (maximum vunerability) | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary rehabilitation, home-based