search
Back to results

Pulmonary Rehabilitation in Patients With Sarcoidosis

Primary Purpose

Stage 4 Pulmonary Sarcoidosis

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pulmonary rehabilitation program
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stage 4 Pulmonary Sarcoidosis focused on measuring Sarcoidosis, pulmonary rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinique des Maladies Respiratoires, CHRU de LILLE
  • Service de Pneumologie, CH Béthune
  • Service de Pneumologie, CH Arras
  • Service de pneumologie, Hôpital Avicenne AP-HP
  • CHU Nord, APHM Marseille
  • Service de Pneumologie, Hôpital Pasteur - Pavillon H, CHU de Nice
  • Service de Pneumologie, Hôpital européen Georges Pompidou. AP-HP
  • Centre Hospitalier Lyon Sud
  • Hôpital Maison Blanche, CHU de Reims
  • Service de Pneumologie, Hôpital Victor Provo
  • Clinique des Voies Respiratoires, Hôpital Larrey

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pulmonary rehabilitation

Controls

Arm Description

Sarcoidosis patients will realize a pulmonary rehabilitation program

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Daily activity assessed by time spent in moderate activity (superior to 2,5 MET)
exercise capacity assessed by symptom-limited cardiopulmonary exercise test, 6 minutes walk test, endurance test on bicycle, St Etienne questionnaire, 6 minutes stepper test
MRC scale for dyspnea
Questionnaire to evaluate quality of life and/or psychological state : VSRQ
Questionnaire to evaluate quality of life and/or psychological state : MRF 28
Questionnaire to evaluate quality of life and/or psychological state : HAD
Questionnaire to evaluate quality of life and/or psychological state : FAS
Questionnaire to evaluate quality of life and/or psychological state : DIRECT

Full Information

First Posted
January 22, 2014
Last Updated
June 19, 2018
Sponsor
University Hospital, Lille
search

1. Study Identification

Unique Protocol Identification Number
NCT02044939
Brief Title
Pulmonary Rehabilitation in Patients With Sarcoidosis
Official Title
Pulmonary Rehabilitation in Fibrotic Pulmonary Sarcoidosis (Stage IV): Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
Not enough recruitment
Study Start Date
July 10, 2012 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage 4 Pulmonary Sarcoidosis
Keywords
Sarcoidosis, pulmonary rehabilitation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulmonary rehabilitation
Arm Type
Experimental
Arm Description
Sarcoidosis patients will realize a pulmonary rehabilitation program
Arm Title
Controls
Arm Type
No Intervention
Arm Description
Sarcoidosis patients who do not achieve a respiratory rehabilitation program but will have physical activity counseling.
Intervention Type
Other
Intervention Name(s)
Pulmonary rehabilitation program
Intervention Description
Pulmonary rehabilitation program should follow ATS/ERS Guidelines (2006)
Primary Outcome Measure Information:
Title
Daily activity assessed by time (in minutes) spent in moderate activity (superior to 2,5 MET)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Daily activity assessed by time spent in moderate activity (superior to 2,5 MET)
Time Frame
2 and 6 months
Title
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
Title
MRC scale for dyspnea
Time Frame
2, 6 and 12 months
Title
Questionnaire to evaluate quality of life and/or psychological state : VSRQ
Time Frame
2, 6 and 12 months
Title
Questionnaire to evaluate quality of life and/or psychological state : MRF 28
Time Frame
2, 6 and 12 months
Title
Questionnaire to evaluate quality of life and/or psychological state : HAD
Time Frame
2, 6 and 12 months
Title
Questionnaire to evaluate quality of life and/or psychological state : FAS
Time Frame
2, 6 and 12 months
Title
Questionnaire to evaluate quality of life and/or psychological state : DIRECT
Time Frame
2, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benoît WALLAERT, MD PhD
Organizational Affiliation
Clinique des Maladies Respiratoires, CHRU de Lille
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frédéric BART, MD
Organizational Affiliation
Service de Pneumologie, CH Béthune
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dominique VALEYRE, MD PhD
Organizational Affiliation
Service de pneumologie, Hôpital Avicenne AP-HP
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dominique ISRAEL-BIET, MD PhD
Organizational Affiliation
Service de Pneumologie, Hôpital européen Georges Pompidou. AP-HP
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean AMOURETTE, MD
Organizational Affiliation
Service de Pneumologie, CH Arras
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yves PACHECO, MD PhD
Organizational Affiliation
Centre Hospitalier Lyon Sud
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vincent COTTIN, MD PhD
Organizational Affiliation
Service de Pneumologie, Hôpital Louis Pradel, Lyon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martine REYNAUD-GAUBERT, MD PhD
Organizational Affiliation
CHU Nord, APHM Marseille
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sylvie LEROY, MD
Organizational Affiliation
Service de Pneumologie, Hôpital Pasteur - Pavillon H, CHU de Nice
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gaëtan DESLEE, MD
Organizational Affiliation
Hôpital Maison Blanche, CHU de Reims
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
François STEENHOUWER, MD
Organizational Affiliation
Service de Pneumologie, Hôpital Victor Provo, Roubaix
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alain DIDIER, MD
Organizational Affiliation
Clinique des Voies Respiratoires, Hôpital Larrey, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique des Maladies Respiratoires, CHRU de LILLE
City
Lille
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Facility Name
Service de Pneumologie, CH Béthune
City
Béthune
State/Province
Pas De Calais
ZIP/Postal Code
62408
Country
France
Facility Name
Service de Pneumologie, CH Arras
City
Arras
ZIP/Postal Code
62000
Country
France
Facility Name
Service de pneumologie, Hôpital Avicenne AP-HP
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
CHU Nord, APHM Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Facility Name
Service de Pneumologie, Hôpital Pasteur - Pavillon H, CHU de Nice
City
Nice
ZIP/Postal Code
06002
Country
France
Facility Name
Service de Pneumologie, Hôpital européen Georges Pompidou. AP-HP
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69310
Country
France
Facility Name
Hôpital Maison Blanche, CHU de Reims
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
Service de Pneumologie, Hôpital Victor Provo
City
Roubaix
ZIP/Postal Code
59056
Country
France
Facility Name
Clinique des Voies Respiratoires, Hôpital Larrey
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31855785
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.
Results Reference
derived

Learn more about this trial

Pulmonary Rehabilitation in Patients With Sarcoidosis

We'll reach out to this number within 24 hrs