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
馃嚝馃嚪Pierre Benite, France
H么pital Maison Blanche, CHU de Reims
馃嚝馃嚪Reims, France
Service de Pneumologie, H么pital Victor Provo
馃嚝馃嚪Roubaix, France
Clinique des Voies Respiratoires, H么pital Larrey
馃嚝馃嚪Toulouse, France
Clinique des Maladies Respiratoires, CHRU de LILLE
馃嚝馃嚪Lille, Nord, France
Service de Pneumologie, CH Arras
馃嚝馃嚪Arras, France
Service de pneumologie, H么pital Avicenne AP-HP
馃嚝馃嚪Bobigny, France
CHU Nord, APHM Marseille
馃嚝馃嚪Marseille, France
Service de Pneumologie, H么pital Pasteur - Pavillon H, CHU de Nice
馃嚝馃嚪Nice, France
Service de Pneumologie, H么pital europ茅en Georges Pompidou. AP-HP
馃嚝馃嚪Paris, France
Service de Pneumologie, CH B茅thune
馃嚝馃嚪B茅thune, Pas De Calais, France