Stage 4 Pulmonary Sarcoidosis Clinical Trial
Official title:
Pulmonary Rehabilitation in Fibrotic Pulmonary Sarcoidosis (Stage IV): Randomized Controlled Trial
| Verified date | June 2018 |
| Source | University Hospital, Lille |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Terminated |
| Enrollment | 36 |
| Est. completion date | June 2018 |
| Est. primary completion date | June 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Service de Pneumologie, CH Arras | Arras | |
| France | Service de Pneumologie, CH Béthune | Béthune | Pas De Calais |
| France | Service de pneumologie, Hôpital Avicenne AP-HP | Bobigny | |
| France | Clinique des Maladies Respiratoires, CHRU de LILLE | Lille | Nord |
| 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 | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Lille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | Daily activity assessed by time spent in moderate activity (superior to 2,5 MET) | 2 and 6 months | ||
| Secondary | 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 | ||
| Secondary | MRC scale for dyspnea | 2, 6 and 12 months | ||
| Secondary | Questionnaire to evaluate quality of life and/or psychological state : VSRQ | 2, 6 and 12 months | ||
| Secondary | Questionnaire to evaluate quality of life and/or psychological state : MRF 28 | 2, 6 and 12 months | ||
| Secondary | Questionnaire to evaluate quality of life and/or psychological state : HAD | 2, 6 and 12 months | ||
| Secondary | Questionnaire to evaluate quality of life and/or psychological state : FAS | 2, 6 and 12 months | ||
| Secondary | Questionnaire to evaluate quality of life and/or psychological state : DIRECT | 2, 6 and 12 months |