Pulmonary Rehabilitation in Patients With Sarcoidosis

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

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 Overview

• Status: Completed
• Conditions: Stage 4 Pulmonary Sarcoidosis
• Intervention / Treatment: Other: Pulmonary rehabilitation program

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
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Arras, France, 62000
    • Service de Pneumologie, CH Arras
  • Bobigny, France, 93009
    • Service de pneumologie, Hôpital Avicenne AP-HP
  • Marseille, France, 13354
    • CHU Nord, APHM Marseille
  • Nice, France, 06002
    • Service de Pneumologie, Hôpital Pasteur - Pavillon H, CHU de Nice
  • Paris, France, 75015
    • Service de Pneumologie, Hôpital européen Georges Pompidou. AP-HP
  • Pierre-Bénite, France, 69310
    • Centre Hospitalier Lyon Sud
  • Reims, France, 51100
    • Hôpital Maison Blanche, CHU de Reims
  • Roubaix, France, 59056
    • Service de Pneumologie, Hôpital Victor Provo
  • Toulouse, France, 31059
    • Clinique des Voies Respiratoires, Hôpital Larrey
  • Nord
    • Lille, Nord, France, 59037
      • Clinique des Maladies Respiratoires, CHRU de LILLE
  • Pas De Calais
    • Béthune, Pas De Calais, France, 62408
      • Service de Pneumologie, CH Béthune

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Wallaert B, Kyheng M, Labreuche J, Stelianides S, Wemeau L, Grosbois JM. Long-term effects of pulmonary rehabilitation on daily life physical activity of patients with stage IV sarcoidosis: A randomized controlled trial. Respir Med Res. 2020 Mar;77:1-7. doi: 10.1016/j.resmer.2019.10.003. Epub 2019 Oct 28.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2012
• Primary Completion (Actual): July 6, 2017
• Study Completion (Actual): July 6, 2017

Study Registration Dates

• First Submitted: January 22, 2014
• First Submitted That Met QC Criteria: January 22, 2014
• First Posted (Estimated): January 24, 2014

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Sarcoidosis, pulmonary rehabilitation
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Hypersensitivity; Lymphatic Diseases; Lymphoproliferative Disorders; Lung Diseases, Interstitial; Hypersensitivity, Delayed; Hemic and Lymphatic Diseases; Sarcoidosis, Pulmonary; Sarcoidosis
• Other Study ID Numbers: 2011_23/1917; 2012-A00347-36 (Other Identifier: ID-RCB Number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No