Pulmonary Rehabilitation in Patients With Sarcoidosis

Study Overview
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Brief Summary
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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: 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
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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 : 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

Official Title
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Pulmonary Rehabilitation in Fibrotic Pulmonary Sarcoidosis (Stage IV): Randomized Controlled Trial

Conditions
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Stage 4 Pulmonary Sarcoidosis

Intervention / Treatment
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* Other: Pulmonary rehabilitation program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulmonary rehabilitation<br>Sarcoidosis patients will realize a pulmonary rehabilitation program | Other: Pulmonary rehabilitation program<br>* Pulmonary rehabilitation program should follow ATS/ERS Guidelines (2006)<br>|
| No Intervention: Controls<br>Sarcoidosis patients who do not achieve a respiratory rehabilitation program but will have physical activity counseling. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcoidosis, pulmonary rehabilitation