Respiratory Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Other: Home respiratory rehabilitationOther: Center respiratory rehabilitation
- Registration Number
- NCT03453606
- Lead Sponsor
- University Hospital, Lille
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 670
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.
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,
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description home group Home respiratory rehabilitation - center group Center respiratory rehabilitation -
- Primary Outcome Measures
Name Time Method Change from baseline the 6 minutes Stepper test at 2 months 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
- Secondary Outcome Measures
Name Time Method Percentage of patients expressing a preference marked for home-based respiratory rehabilitation or respiratory rehabilitation in center Baseline Change from baseline the 6 minutes Stepper test at 6 and 12 months at 6 months, at12 months The 6 minutes stepper test (ST6), performed on a Stepper allows to analyze the number of strokes (or steps) performed in 6 minutes
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 baseline, after RR (2 months); 6 months and12 months The COPD assessment test (CAT) is a short questionnaire initially intended for assess quality of life and clinical impact of COPD
Change from Baseline Modified Medical Research Council (MMRC) Dyspnea Scale at 2,6,12 months baseline, after RR (2 months); 6 months and12 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.
Change from Baseline Anxiety and Depression (HAD) at 2,6,12 months Baseline, after RR (2 months); 6 months and12 months To determine the levels of anxiety and depression that a COPD patients are experiencing
EPICES score baseline 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)
Trial Locations
- Locations (7)
Centre hospitalier de béthune
🇫🇷Béthune, France
CH de Béthune
🇫🇷Béthune, France
Hôpital Calmette, CHU
🇫🇷Lille, France
CH de Loos
🇫🇷Loos, France
CH de Tourcoing
🇫🇷Tourcoing, France
CH Victor Provot, Roubaix
🇫🇷Roubaix, France
CH de Wattrelos
🇫🇷Wattrelos, France