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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A00347-36 | Other Identifier | ID-RCB Number, ANSM |
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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:
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary rehabilitation | Experimental | Sarcoidosis patients will realize a pulmonary rehabilitation program |
|
| Controls | No Intervention | Sarcoidosis patients who do not achieve a respiratory rehabilitation program but will have physical activity counseling. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary rehabilitation program | Other | Pulmonary rehabilitation program should follow ATS/ERS Guidelines (2006) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Daily activity assessed by time (in minutes) spent in moderate activity (superior to 2,5 MET) | 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. | 12 months |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
The trial does not include special populations include:
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| Name | Affiliation | Role |
|---|---|---|
| Benoît WALLAERT, MD PhD | Clinique des Maladies Respiratoires, CHRU de Lille | Principal Investigator |
| Frédéric BART, MD | Service de Pneumologie, CH Béthune | Principal Investigator |
| Dominique VALEYRE, MD PhD | Service de pneumologie, Hôpital Avicenne AP-HP | Principal Investigator |
| Dominique ISRAEL-BIET, MD PhD | Service de Pneumologie, Hôpital européen Georges Pompidou. AP-HP | Principal Investigator |
| Jean AMOURETTE, MD | Service de Pneumologie, CH Arras | Principal Investigator |
| Yves PACHECO, MD PhD | Centre Hospitalier Lyon Sud | Principal Investigator |
| Vincent COTTIN, MD PhD | Service de Pneumologie, Hôpital Louis Pradel, Lyon | Principal Investigator |
| Martine REYNAUD-GAUBERT, MD PhD | CHU Nord, APHM Marseille | Principal Investigator |
| Sylvie LEROY, MD | Service de Pneumologie, Hôpital Pasteur - Pavillon H, CHU de Nice |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique des Maladies Respiratoires, CHRU de LILLE | Lille | Nord | 59037 | France | ||
| Service de Pneumologie, CH Béthune |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31855785 | Result | Wallaert B, Kyheng M, Labreuche J, Stelianides S, Wemeau L, Grosbois JM. Long-term effects of pulmonary rehabilitation on daily life physical activity of patients with stage IV sarcoidosis: A randomized controlled trial. Respir Med Res. 2020 Mar;77:1-7. doi: 10.1016/j.resmer.2019.10.003. Epub 2019 Oct 28. |
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| ID | Term |
|---|---|
| D017565 | Sarcoidosis, Pulmonary |
| D012507 | Sarcoidosis |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008232 | Lymphoproliferative Disorders |
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| 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 |
| Principal Investigator |
| Gaëtan DESLEE, MD | Hôpital Maison Blanche, CHU de Reims | Principal Investigator |
| François STEENHOUWER, MD | Service de Pneumologie, Hôpital Victor Provo, Roubaix | Principal Investigator |
| Alain DIDIER, MD | Clinique des Voies Respiratoires, Hôpital Larrey, Toulouse | Principal Investigator |
| Béthune |
| Pas De Calais |
| 62408 |
| France |
| Service de Pneumologie, CH Arras | Arras | 62000 | France |
| Service de pneumologie, Hôpital Avicenne AP-HP | Bobigny | 93009 | France |
| CHU Nord, APHM Marseille | Marseille | 13354 | France |
| Service de Pneumologie, Hôpital Pasteur - Pavillon H, CHU de Nice | Nice | 06002 | France |
| Service de Pneumologie, Hôpital européen Georges Pompidou. AP-HP | Paris | 75015 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69310 | France |
| Hôpital Maison Blanche, CHU de Reims | Reims | 51100 | France |
| Service de Pneumologie, Hôpital Victor Provo | Roubaix | 59056 | France |
| Clinique des Voies Respiratoires, Hôpital Larrey | Toulouse | 31059 | France |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |