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 ]

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.


Original Primary Outcome: Daily activity assessed by time (in minutes) spent in moderate activity (superior to 2,5 MET) [ Time Frame: 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 4,5 days including the weekend.


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