Stage 4 Pulmonary SarcoidosisNCT02044939
Pulmonary Rehabilitation in Patients With Sarcoidosis
A study testing Pulmonary rehabilitation program in people with Stage 4 Pulmonary Sarcoidosis, run by University Hospital, Lille at 11 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage 4 Pulmonary Sarcoidosis
- What is being tested?
- Pulmonary rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 11 sitesFrance
- Study dates
- 10 Jul 2012to 6 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage IV Sarcoidosis
- No hospitalization for respiratory distress in the 3 months preceding the inclusion
- Dyspnea on exertion
- Age over 18 years
Who cannot join
- 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
Show all 12Show fewer
- The trial does not include special populations include:
- Pregnant women
- Breastfeeding women
- People in emergencies
- Persons unable to consent
- Persons deprived of liberty
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Service de Pneumologie, CH Arras
Arras, 62000
Service de Pneumologie, CH Béthune
Béthune, Pas De Calais, 62408
Service de pneumologie, Hôpital Avicenne AP-HP
Bobigny, 93009
Clinique des Maladies Respiratoires, CHRU de LILLE
Lille, Nord, 59037
CHU Nord, APHM Marseille
Marseille, 13354
Service de Pneumologie, Hôpital Pasteur - Pavillon H, CHU de Nice
Nice, 06002
Service de Pneumologie, Hôpital européen Georges Pompidou. AP-HP
Paris, 75015
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
Hôpital Maison Blanche, CHU de Reims
Reims, 51100
Service de Pneumologie, Hôpital Victor Provo
Roubaix, 59056
Clinique des Voies Respiratoires, Hôpital Larrey
Toulouse, 31059
About this study
Official title: 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
Read the 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
- Conditions
- Stage 4 Pulmonary Sarcoidosis
- Being tested
- Pulmonary rehabilitation program
- Keywords
- Sarcoidosis, pulmonary rehabilitation
- Medical subject headings
- Sarcoidosis, Pulmonary, Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitation programOther
Pulmonary rehabilitation program should follow ATS/ERS Guidelines (2006)
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary rehabilitation | Experimental | Sarcoidosis patients will realize a pulmonary rehabilitation program Receives: Other: Pulmonary rehabilitation program |
| Controls | No intervention | Sarcoidosis patients who do not achieve a respiratory rehabilitation program but will have physical activity counseling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (8)
Daily activity assessed by time spent in moderate activity (superior to 2,5 MET)
Measured: 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
Measured: 2, 6 and 12 months
MRC scale for dyspnea
Measured: 2, 6 and 12 months
Questionnaire to evaluate quality of life and/or psychological state : VSRQ
Measured: 2, 6 and 12 months
Questionnaire to evaluate quality of life and/or psychological state : MRF 28
Measured: 2, 6 and 12 months
Questionnaire to evaluate quality of life and/or psychological state : HAD
Measured: 2, 6 and 12 months
Questionnaire to evaluate quality of life and/or psychological state : FAS
Measured: 2, 6 and 12 months
Questionnaire to evaluate quality of life and/or psychological state : DIRECT
Measured: 2, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study start10 Jul 2012
- Primary completion6 Jul 2017
- Study completion6 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage 4 Pulmonary SarcoidosisStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoît WALLAERT, MD PhD, Principal investigator, Clinique des Maladies Respiratoires, CHRU de LilleFrédéric BART, MD, Principal investigator, Service de Pneumologie, CH BéthuneDominique VALEYRE, MD PhD, Principal investigator, Service de pneumologie, Hôpital Avicenne AP-HPDominique ISRAEL-BIET, MD PhD, Principal investigator, Service de Pneumologie, Hôpital européen Georges Pompidou. AP-HPJean AMOURETTE, MD, Principal investigator, Service de Pneumologie, CH ArrasYves PACHECO, MD PhD, Principal investigator, Centre Hospitalier Lyon SudVincent COTTIN, MD PhD, Principal investigator, Service de Pneumologie, Hôpital Louis Pradel, LyonMartine REYNAUD-GAUBERT, MD PhD, Principal investigator, CHU Nord, APHM Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044939
- Sponsor's protocol ID
- 2011_23/1917
- Other IDs
- 2012-A00347-36
- Status last verified
- Apr 2026
- First submitted
- 22 Jan 2014
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31855785
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Rehabilitation in Fibrotic Pulmonary Sarcoidosis (Stage IV): Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02044939
- Acronym / sponsor ID
- 2011_23/1917
- Conditions
- Stage 4 Pulmonary Sarcoidosis
- Keywords
- Sarcoidosis, pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 10 Jul 2012 (actual)
- Primary completion
- 6 Jul 2017 (actual)
- Study completion
- 6 Jul 2017 (actual)
- First posted
- 24 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary rehabilitation | Experimental | Other: Pulmonary rehabilitation programSarcoidosis patients will realize a pulmonary rehabilitation program |
| Controls | No intervention | –Sarcoidosis patients who do not achieve a respiratory rehabilitation program but will have physical activity counseling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stage IV Sarcoidosis
- No hospitalization for respiratory distress in the 3 months preceding the inclusion
- Dyspnea on exertion
- Age over 18 years
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary rehabilitation programPulmonary rehabilitation program should follow ATS/ERS Guidelines (2006) | Other | Pulmonary rehabilitation |
Primary outcome
Daily activity assessed by time (in minutes) spent in moderate activity (superior to 2,5 MET)
Time frame: 12 months
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.
8 secondary outcomes
Daily activity assessed by time spent in moderate activity (superior to 2,5 MET)
Time frame: 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
Time frame: 2, 6 and 12 months
MRC scale for dyspnea
Time frame: 2, 6 and 12 months
Questionnaire to evaluate quality of life and/or psychological state : VSRQ
Time frame: 2, 6 and 12 months
Questionnaire to evaluate quality of life and/or psychological state : MRF 28
Time frame: 2, 6 and 12 months
Questionnaire to evaluate quality of life and/or psychological state : HAD
Time frame: 2, 6 and 12 months
Questionnaire to evaluate quality of life and/or psychological state : FAS
Time frame: 2, 6 and 12 months
Questionnaire to evaluate quality of life and/or psychological state : DIRECT
Time frame: 2, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Results publication: PubMed 31855785Wallaert 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoît WALLAERT, MD PhD principal investigator
Clinique des Maladies Respiratoires, CHRU de Lille
Frédéric BART, MD principal investigator
Service de Pneumologie, CH Béthune
Dominique VALEYRE, MD PhD principal investigator
Service de pneumologie, Hôpital Avicenne AP-HP
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation program in people with Stage 4 Pulmonary Sarcoidosis, run by University Hospital, Lille at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily activity assessed by time (in minutes) spent in moderate activity (superior to 2,5 MET) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02044939, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.