Pulmonary Rehabilitation in Patients With Sarcoidosis

NCT ID: NCT02044939

Last Updated: 2018-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-10

Study Completion Date

2018-06-30

Brief Summary

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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

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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

Conditions

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Stage 4 Pulmonary Sarcoidosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Pulmonary rehabilitation

Sarcoidosis patients will realize a pulmonary rehabilitation program

Group Type EXPERIMENTAL

Pulmonary rehabilitation program

Intervention Type OTHER

Pulmonary rehabilitation program should follow ATS/ERS Guidelines (2006)

Controls

Sarcoidosis patients who do not achieve a respiratory rehabilitation program but will have physical activity counseling.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pulmonary rehabilitation program

Pulmonary rehabilitation program should follow ATS/ERS Guidelines (2006)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benoît WALLAERT, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Clinique des Maladies Respiratoires, CHRU de Lille

Frédéric BART, MD

Role: PRINCIPAL_INVESTIGATOR

Service de Pneumologie, CH Béthune

Dominique VALEYRE, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Service de pneumologie, Hôpital Avicenne AP-HP

Dominique ISRAEL-BIET, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Service de Pneumologie, Hôpital européen Georges Pompidou. AP-HP

Jean AMOURETTE, MD

Role: PRINCIPAL_INVESTIGATOR

Service de Pneumologie, CH Arras

Yves PACHECO, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Lyon Sud

Vincent COTTIN, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Service de Pneumologie, Hôpital Louis Pradel, Lyon

Martine REYNAUD-GAUBERT, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Nord, APHM Marseille

Sylvie LEROY, MD

Role: PRINCIPAL_INVESTIGATOR

Service de Pneumologie, Hôpital Pasteur - Pavillon H, CHU de Nice

Gaëtan DESLEE, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Maison Blanche, CHU de Reims

François STEENHOUWER, MD

Role: PRINCIPAL_INVESTIGATOR

Service de Pneumologie, Hôpital Victor Provo, Roubaix

Alain DIDIER, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique des Voies Respiratoires, Hôpital Larrey, Toulouse

Locations

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Clinique des Maladies Respiratoires, CHRU de LILLE

Lille, Nord, France

Site Status

Service de Pneumologie, CH Béthune

Béthune, Pas De Calais, France

Site Status

Service de Pneumologie, CH Arras

Arras, , France

Site Status

Service de pneumologie, Hôpital Avicenne AP-HP

Bobigny, , France

Site Status

CHU Nord, APHM Marseille

Marseille, , France

Site Status

Service de Pneumologie, Hôpital Pasteur - Pavillon H, CHU de Nice

Nice, , France

Site Status

Service de Pneumologie, Hôpital européen Georges Pompidou. AP-HP

Paris, , France

Site Status

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status

Hôpital Maison Blanche, CHU de Reims

Reims, , France

Site Status

Service de Pneumologie, Hôpital Victor Provo

Roubaix, , France

Site Status

Clinique des Voies Respiratoires, Hôpital Larrey

Toulouse, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 31855785 (View on PubMed)

Other Identifiers

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2012-A00347-36

Identifier Type: OTHER

Identifier Source: secondary_id

2011_23/1917

Identifier Type: -

Identifier Source: org_study_id

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