Stage 4 Pulmonary Sarcoidosis
Conditions
Keywords
Sarcoidosis, pulmonary rehabilitation
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
Interventions
Pulmonary rehabilitation program should follow ATS/ERS Guidelines (2006)
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Stage IV Sarcoidosis * No hospitalization for respiratory distress in the 3 months preceding the inclusion * Dyspnea on exertion * Age over 18 years
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Daily activity assessed by time spent in moderate activity (superior to 2,5 MET) | 2 and 6 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 : VSRQ | 2, 6 and 12 months |
| Questionnaire to evaluate quality of life and/or psychological state : MRF 28 | 2, 6 and 12 months |
| Questionnaire to evaluate quality of life and/or psychological state : HAD | 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORBenoît WALLAERT, MD PhD
Clinique des Maladies Respiratoires, CHRU de Lille
PRINCIPAL_INVESTIGATORFrédéric BART, MD
Service de Pneumologie, CH Béthune
PRINCIPAL_INVESTIGATORDominique VALEYRE, MD PhD
Service de pneumologie, Hôpital Avicenne AP-HP
PRINCIPAL_INVESTIGATORDominique ISRAEL-BIET, MD PhD
Service de Pneumologie, Hôpital européen Georges Pompidou. AP-HP
PRINCIPAL_INVESTIGATORJean AMOURETTE, MD
Service de Pneumologie, CH Arras
PRINCIPAL_INVESTIGATORYves PACHECO, MD PhD
Centre Hospitalier Lyon Sud
PRINCIPAL_INVESTIGATORVincent COTTIN, MD PhD
Service de Pneumologie, Hôpital Louis Pradel, Lyon
PRINCIPAL_INVESTIGATORMartine REYNAUD-GAUBERT, MD PhD
CHU Nord, APHM Marseille
PRINCIPAL_INVESTIGATORSylvie LEROY, MD
Service de Pneumologie, Hôpital Pasteur - Pavillon H, CHU de Nice
PRINCIPAL_INVESTIGATORGaëtan DESLEE, MD
Hôpital Maison Blanche, CHU de Reims
PRINCIPAL_INVESTIGATORFrançois STEENHOUWER, MD
Service de Pneumologie, Hôpital Victor Provo, Roubaix
PRINCIPAL_INVESTIGATORAlain DIDIER, MD
Clinique des Voies Respiratoires, Hôpital Larrey, Toulouse
Outcome results
None listed