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Pulmonary Rehabilitation in Patients With Sarcoidosis

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ClinicalTrials.gov Identifier: NCT02044939
Recruitment Status : Terminated (Not enough recruitment)
First Posted : January 24, 2014
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Stage 4 Pulmonary Sarcoidosis Other: Pulmonary rehabilitation program Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pulmonary Rehabilitation in Fibrotic Pulmonary Sarcoidosis (Stage IV): Randomized Controlled Trial
Actual Study Start Date : July 10, 2012
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pulmonary rehabilitation
Sarcoidosis patients will realize a pulmonary rehabilitation program
Other: Pulmonary rehabilitation program
Pulmonary rehabilitation program should follow ATS/ERS Guidelines (2006)

No Intervention: Controls
Sarcoidosis patients who do not achieve a respiratory rehabilitation program but will have physical activity counseling.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Daily activity assessed by time spent in moderate activity (superior to 2,5 MET) [ Time Frame: 2 and 6 months ]
  2. 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 ]
  3. MRC scale for dyspnea [ Time Frame: 2, 6 and 12 months ]
  4. Questionnaire to evaluate quality of life and/or psychological state : VSRQ [ Time Frame: 2, 6 and 12 months ]
  5. Questionnaire to evaluate quality of life and/or psychological state : MRF 28 [ Time Frame: 2, 6 and 12 months ]
  6. Questionnaire to evaluate quality of life and/or psychological state : HAD [ Time Frame: 2, 6 and 12 months ]
  7. Questionnaire to evaluate quality of life and/or psychological state : FAS [ Time Frame: 2, 6 and 12 months ]
  8. Questionnaire to evaluate quality of life and/or psychological state : DIRECT [ Time Frame: 2, 6 and 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02044939


Locations
France
Clinique des Maladies Respiratoires, CHRU de LILLE
Lille, Nord, France, 59037
Service de Pneumologie, CH Béthune
Béthune, Pas De Calais, France, 62408
Service de Pneumologie, CH Arras
Arras, France, 62000
Service de pneumologie, Hôpital Avicenne AP-HP
Bobigny, France, 93009
CHU Nord, APHM Marseille
Marseille, France, 13354
Service de Pneumologie, Hôpital Pasteur - Pavillon H, CHU de Nice
Nice, France, 06002
Service de Pneumologie, Hôpital européen Georges Pompidou. AP-HP
Paris, France, 75015
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69310
Hôpital Maison Blanche, CHU de Reims
Reims, France, 51100
Service de Pneumologie, Hôpital Victor Provo
Roubaix, France, 59056
Clinique des Voies Respiratoires, Hôpital Larrey
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Benoît WALLAERT, MD PhD Clinique des Maladies Respiratoires, CHRU de Lille
Principal Investigator: Frédéric BART, MD Service de Pneumologie, CH Béthune
Principal Investigator: Dominique VALEYRE, MD PhD Service de pneumologie, Hôpital Avicenne AP-HP
Principal Investigator: Dominique ISRAEL-BIET, MD PhD Service de Pneumologie, Hôpital européen Georges Pompidou. AP-HP
Principal Investigator: Jean AMOURETTE, MD Service de Pneumologie, CH Arras
Principal Investigator: Yves PACHECO, MD PhD Centre Hospitalier Lyon Sud
Principal Investigator: Vincent COTTIN, MD PhD Service de Pneumologie, Hôpital Louis Pradel, Lyon
Principal Investigator: Martine REYNAUD-GAUBERT, MD PhD CHU Nord, APHM Marseille
Principal Investigator: Sylvie LEROY, MD Service de Pneumologie, Hôpital Pasteur - Pavillon H, CHU de Nice
Principal Investigator: Gaëtan DESLEE, MD Hôpital Maison Blanche, CHU de Reims
Principal Investigator: François STEENHOUWER, MD Service de Pneumologie, Hôpital Victor Provo, Roubaix
Principal Investigator: Alain DIDIER, MD Clinique des Voies Respiratoires, Hôpital Larrey, Toulouse

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02044939     History of Changes
Other Study ID Numbers: 2011_23/1917
2012-A00347-36 ( Other Identifier: ID-RCB Number, ANSM )
First Posted: January 24, 2014    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
Sarcoidosis, pulmonary rehabilitation

Additional relevant MeSH terms:
Sarcoidosis
Sarcoidosis, Pulmonary
Lymphoproliferative Disorders
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases