Clinical trial NCT02044939: Pulmonary Rehabilitation in Patients With Sarcoidosis
Official title: Pulmonary Rehabilitation in Fibrotic Pulmonary Sarcoidosis (Stage IV): Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stage 4 Pulmonary Sarcoidosis
Keywords: Sarcoidosis, pulmonary rehabilitation
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2014-01-24
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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 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

Primary outcomes:
measure: Daily activity assessed by time (in minutes) spent in moderate activity (superior to 2,5 MET)
timeFrame: 12 months
Secondary outcomes:
measure: Daily activity assessed by time spent in moderate activity (superior to 2,5 MET)
timeFrame: 2 and 6 months
measure: exercise capacity assessed by symptom-limited cardiopulmonary exercise test, 6 minutes walk test, endurance test on bicycle, St Etienne questionnaire, 6 minutes stepper test
timeFrame: 2, 6 and 12 months
measure: MRC scale for dyspnea
timeFrame: 2, 6 and 12 months
measure: Questionnaire to evaluate quality of life and/or psychological state : VSRQ
timeFrame: 2, 6 and 12 months
measure: Questionnaire to evaluate quality of life and/or psychological state : MRF 28
timeFrame: 2, 6 and 12 months
measure: Questionnaire to evaluate quality of life and/or psychological state : HAD
timeFrame: 2, 6 and 12 months
measure: Questionnaire to evaluate quality of life and/or psychological state : FAS
timeFrame: 2, 6 and 12 months
measure: Questionnaire to evaluate quality of life and/or psychological state : DIRECT
timeFrame: 2, 6 and 12 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Clinique des Maladies Respiratoires, CHRU de LILLE
state: Nord
city: Béthune
country: France
facility: Service de Pneumologie, CH Béthune
state: Pas De Calais
city: Arras
country: France
facility: Service de Pneumologie, CH Arras
city: Bobigny
country: France
facility: Service de pneumologie, Hôpital Avicenne AP-HP
city: Marseille
country: France
facility: CHU Nord, APHM Marseille
city: Nice
country: France
facility: Service de Pneumologie, Hôpital Pasteur - Pavillon H, CHU de Nice
city: Paris
country: France
facility: Service de Pneumologie, Hôpital européen Georges Pompidou. AP-HP
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Reims
country: France
facility: Hôpital Maison Blanche, CHU de Reims
city: Roubaix
country: France
facility: Service de Pneumologie, Hôpital Victor Provo
city: Toulouse
country: France
facility: Clinique des Voies Respiratoires, Hôpital Larrey
Study officials:
affiliation: Clinique des Maladies Respiratoires, CHRU de Lille
name: Benoît WALLAERT, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service de Pneumologie, CH Béthune
name: Frédéric BART, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service de pneumologie, Hôpital Avicenne AP-HP
name: Dominique VALEYRE, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service de Pneumologie, Hôpital européen Georges Pompidou. AP-HP
name: Dominique ISRAEL-BIET, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service de Pneumologie, CH Arras
name: Jean AMOURETTE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Lyon Sud
name: Yves PACHECO, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service de Pneumologie, Hôpital Louis Pradel, Lyon
name: Vincent COTTIN, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Nord, APHM Marseille
name: Martine REYNAUD-GAUBERT, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service de Pneumologie, Hôpital Pasteur - Pavillon H, CHU de Nice
name: Sylvie LEROY, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Maison Blanche, CHU de Reims
name: Gaëtan DESLEE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service de Pneumologie, Hôpital Victor Provo, Roubaix
name: François STEENHOUWER, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique des Voies Respiratoires, Hôpital Larrey, Toulouse
name: Alain DIDIER, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.