Clinical Trial: Pulmonary Rehabilitation in Patients With Sarcoidosis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Pulmonary Rehabilitation in Fibrotic Pulmonary Sarcoidosis (Stage IV): Randomized Controlled Trial
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 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
Sponsor: University Hospital, Lille
Current Primary Outcome: Daily activity assessed by time (in minutes) spent in moderate activity (superior to 2,5 MET) [ Time Frame: 12 months ]
Original Primary Outcome: Daily activity assessed by time (in minutes) spent in moderate activity (superior to 2,5 MET) [ Time Frame: 12 months ]
Current Secondary Outcome:
- Daily activity assessed by time spent in moderate activity (superior to 2,5 MET) [ Time Frame: 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 [ Time Frame: 2, 6 and 12 months ]
- MRC scale for dyspnea [ Time Frame: 2, 6 and 12 months ]
- Questionnaire to evaluate quality of life and/or psychological state : VSRQ [ Time Frame: 2, 6 and 12 months ]
- Questionnaire to evaluate quality of life and/or psychological state : MRF 28 [ Time Frame: 2, 6 and 12 months ]
- Questionnaire to evaluate quality of life and/or psychological state : HAD [ Time Frame: 2, 6 and 12 months ]
- Questionnaire to evaluate quality of life and/or psychological state : FAS [ Time Frame: 2, 6 and 12 months ]
- Questionnaire to evaluate quality of life and/or psychological state : DIRECT [ Time Frame: 2, 6 and 12 months ]
Original Secondary Outcome:
- Daily activity assessed by time spent in moderate activity (superior to 2,5 MET) [ Time Frame: 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 [ Time Frame: 2, 6 and 12 months ]
- MRC scale for dyspnea [ Time Frame: 2, 6 and 12 months ]
- Several questionnaires to evaluate quality of life and psychological state : VSRQ, MRF 28, HAD [ Time Frame: 2, 6 and 12 months ]
Information By: University Hospital, Lille
Dates:
Date Received: January 22, 2014
Date Started: July 10, 2012
Date Completion: July 2018
Last Updated: May 17, 2017
Last Verified: May 2017