Pulmonary Rehabilitation in Patients With Sarcoidosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Hospital, Lille
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT02044939
First received: January 22, 2014
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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 Intervention
Stage 4 Pulmonary Sarcoidosis
Other: Pulmonary rehabilitation program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pulmonary Rehabilitation in Fibrotic Pulmonary Sarcoidosis (Stage IV): Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • Daily activity assessed by time (in minutes) spent in moderate activity (superior to 2,5 MET) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • Daily activity assessed by time spent in moderate activity (superior to 2,5 MET) [ Time Frame: 2 and 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • MRC scale for dyspnea [ Time Frame: 2, 6 and 12 months ] [ Designated as safety issue: No ]
  • Questionnaire to evaluate quality of life and/or psychological state : VSRQ [ Time Frame: 2, 6 and 12 months ] [ Designated as safety issue: No ]
  • Questionnaire to evaluate quality of life and/or psychological state : MRF 28 [ Time Frame: 2, 6 and 12 months ] [ Designated as safety issue: No ]
  • Questionnaire to evaluate quality of life and/or psychological state : HAD [ Time Frame: 2, 6 and 12 months ] [ Designated as safety issue: No ]
  • Questionnaire to evaluate quality of life and/or psychological state : FAS [ Time Frame: 2, 6 and 12 months ] [ Designated as safety issue: No ]
  • Questionnaire to evaluate quality of life and/or psychological state : DIRECT [ Time Frame: 2, 6 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: June 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02044939

Contacts
Contact: Benoît WALLAERT, MD PhD +33 320 44 59 48 benoit.wallaert@chru-lille.fr
Contact: Morgane FOULON, CRA +33 320 44 59 48 ext 30966 morgane.foulon@chru-lille.fr

Locations
France
Clinique des Maladies Respiratoires, CHRU de LILLE Recruiting
Lille, Nord, France, 59037
Contact: Benoît WALLAERT, MD PhD    +33 320 44 59 48    benoit.wallaert@chru-lille.fr   
Contact: Morgane FOULON, CRA    + 33 320 44 59 48    morgane.foulon@chru-lille.fr   
Principal Investigator: Benoît WALLAERT, MD PhD         
Service de Pneumologie, CH Béthune Not yet recruiting
Béthune, Pas de Calais, France, 62408
Contact: Frédéric BART, MD    +33 321 64 43 36    fbart@ch-bethune.fr   
Principal Investigator: Frédéric BART, MD         
Service de Pneumologie, CH Arras Not yet recruiting
Arras, France, 62000
Contact: Jean AMOURETTE, MD PhD    +33 3 21 21 13 46    jean.amourette@ch-arras.fr   
Principal Investigator: Jean AMOURETTE, MD PhD         
Service de pneumologie, Hôpital Avicenne AP-HP Active, not recruiting
Bobigny, France, 93009
Service de Pneumologie, Hôpital Louis Pradel Not yet recruiting
Bron, France, 69677
Contact: Vincent COTTIN, MD PhD    +33 4 72 35 70 72    vincent.cottin@chu-lyon.fr   
Principal Investigator: Vincent COTTIN, MD PhD         
CHU Nord, APHM Marseille Not yet recruiting
Marseille, France, 13354
Contact: Martine REYNAUD-GAUBERT, MD PhD    +33 4 91 96 61 45    martine.reynaud@ap-hm.fr   
Principal Investigator: Martine REYNAUD-GAUBERT, MD PhD         
Service de Pneumologie, Hôpital Pasteur - Pavillon H, CHU de Nice Active, not recruiting
Nice, France, 06002
Service de Pneumologie, Hôpital européen Georges Pompidou. AP-HP Active, not recruiting
Paris, France, 75015
Centre Hospitalier Lyon Sud Not yet recruiting
Pierre Benite, France, 69310
Contact: Yves PACHECO, MD PhD    +33 4.78.86.15.18    yves.pacheco@chu-lyon.fr   
Principal Investigator: Yves PACHECO, MD PhD         
Hôpital Maison Blanche, CHU de Reims Not yet recruiting
Reims, France, 51100
Contact: Gaëtan DESLEE, MD    +33 3 26 78 37 71    gdeslee@chu-reims.fr   
Principal Investigator: Gaëtan DESLEE, MD         
Service de Pneumologie, Hôpital Victor Provo Not yet recruiting
Roubaix, France, 59056
Contact: François STEENHOUWER, MD    +33 3.20.99.31.74    francois.steenhouwer@ch-roubaix.fr   
Principal Investigator: François STEENHOUWER, MD         
Clinique des Voies Respiratoires, Hôpital Larrey Active, not recruiting
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
  More Information

No publications provided

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02044939     History of Changes
Other Study ID Numbers: 2011_23/1917
Study First Received: January 22, 2014
Last Updated: June 18, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

ClinicalTrials.gov processed this record on July 20, 2014