Pulmonary Rehabilitation in Patients With Sarcoidosis
- Conditions
- Stage 4 Pulmonary Sarcoidosis
- Interventions
- Other: Pulmonary rehabilitation program
- Registration Number
- NCT02044939
- Lead Sponsor
- University Hospital, Lille
- Brief Summary
The primary objective of the study is to assess the improvement of daily activity in subjects with Stage IV Pulmonary Sarcoidosis one year after the conduct of a pulmonary rehabilitation program.
The secondary objectives are the following:
* assess the improvement of daily activity at several times : 2, 6 and 12 months after the beginning of a pulmonary rehabilitation program
* assess the improvement of exercise capacity by tests used in medical practice
* assess the correlation between daily activity and exercise capacity
* assess the improvement of dyspnea
* assess the improvement of quality of life and psychological state
- Detailed Description
The primary objective of the study is to assess the improvement of daily activity in subjects with Stage IV Pulmonary Sarcoidosis one year after the conduct of a pulmonary rehabilitation program
The secondary objectives are the following :
* assess the improvement of daily activity at several times : 2, 6 and 12 months after the beginning of a pulmonary rehabilitation program
* assess the improvement of exercise capacity by tests used in medical practice
* assess the correlation between daily activity and exercise capacity
* assess the improvement of dyspnea
* assess the improvement of quality of life and psychological state
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 36
- Stage IV Sarcoidosis
- No hospitalization for respiratory distress in the 3 months preceding the inclusion
- Dyspnea on exertion
- Age over 18 years
- Physical disability does not allow the creation of a rehabilitation program
- Inability to give written consent to the study
- Refusal of contraception in women of childbearing age
- Inability to participate in the entire study
- No cover by the social security system
- Inability to perform self-questionnaires etude
The trial does not include special populations include:
- Pregnant women
- Breastfeeding women
- People in emergencies
- Persons unable to consent
- Persons deprived of liberty
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pulmonary rehabilitation Pulmonary rehabilitation program Sarcoidosis patients will realize a pulmonary rehabilitation program
- Primary Outcome Measures
Name Time Method Daily activity assessed by time (in minutes) spent in moderate activity (superior to 2,5 MET) 12 months In everyday life, it corresponds to a walking in 5 km/h or in domestic chores. This measure will be realized by using Armband's accelerometer, in ambulatory. The measure will be realized over a period of 4 full days including the weekend.
- Secondary Outcome Measures
Name Time Method Questionnaire to evaluate quality of life and/or psychological state : VSRQ 2, 6 and 12 months Questionnaire to evaluate quality of life and/or psychological state : FAS 2, 6 and 12 months Questionnaire to evaluate quality of life and/or psychological state : DIRECT 2, 6 and 12 months exercise capacity assessed by symptom-limited cardiopulmonary exercise test, 6 minutes walk test, endurance test on bicycle, St Etienne questionnaire, 6 minutes stepper test 2, 6 and 12 months MRC scale for dyspnea 2, 6 and 12 months Questionnaire to evaluate quality of life and/or psychological state : MRF 28 2, 6 and 12 months Daily activity assessed by time spent in moderate activity (superior to 2,5 MET) 2 and 6 months Questionnaire to evaluate quality of life and/or psychological state : HAD 2, 6 and 12 months
Trial Locations
- Locations (11)
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite, France
Hôpital Maison Blanche, CHU de Reims
🇫🇷Reims, France
Service de Pneumologie, Hôpital Victor Provo
🇫🇷Roubaix, France
Clinique des Voies Respiratoires, Hôpital Larrey
🇫🇷Toulouse, France
Clinique des Maladies Respiratoires, CHRU de LILLE
🇫🇷Lille, Nord, France
Service de Pneumologie, CH Arras
🇫🇷Arras, France
Service de pneumologie, Hôpital Avicenne AP-HP
🇫🇷Bobigny, France
CHU Nord, APHM Marseille
🇫🇷Marseille, France
Service de Pneumologie, Hôpital Pasteur - Pavillon H, CHU de Nice
🇫🇷Nice, France
Service de Pneumologie, Hôpital européen Georges Pompidou. AP-HP
🇫🇷Paris, France
Service de Pneumologie, CH Béthune
🇫🇷Béthune, Pas De Calais, France