DermatomyositisPhase 2NCT01415219
Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis
A Phase 2 study testing Active rehabilitation in people with Dermatomyositis and Polymyositis, run by University Hospital, Lille at 5 sites in France.
Trial summary
The purpose of this study is to evaluate the efficacy of an active rehabilitation program on disability and quality of life of patients affected by dermatomyositis and polymyositis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dermatomyositis, Polymyositis
- What is being tested?
- Active rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 5 sitesFrance
- Study dates
- Mar 2008to Dec 2013
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of Dermatomyositis ore polymyositis according to the International Myositis Assessment and Clinical Studies Group
- functional impairment (an HAQ score greater than 0.5)
- stability of muscle impairment
- medical insurance
Who cannot join
- no recent inflammatory activity
- other chronic disease
- cognitive impairment
- patients who participated to a rehabilitation program before inclusion
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
University Hospital, Lille
Lille, Hauts-de-France, 59037
Hopital Rotschild
Paris, 75571
GH Pitié Salpétrière
Paris, 75651
Hopital Cochin
Paris, 75679
Centre hospitalier universitaire de Rouen
Rouen, 76031
About this study
The purpose of this study is to evaluate the efficacy of an active rehabilitation program on disability and quality of life of patients affected by dermatomyositis and polymyositis.
Read the detailed description
Dermatomyositis (DM) and polymyositis (PM) are inflammatory disabling neuromuscular disorders. Despite partial benefit of pharmacological treatments, muscle strength, functional status and quality of life remain impaired. Although the use muscle exercises in (DM) and (PM) have been reported, its efficacy on disability and quality of life has not been proved.
Te aim of the study is to evaluate the benefit at mid term (12 months) of an active rehabilitation program administrated to patients affected by PM and DM.
Method: a 3 year prospective, multicentric, randomized controlled trial A program of 12 individual exercise sessions (3 per week during 4 weeks) is compared to conventional care. Patients are followed 12 month after the inclusion.
- Conditions
- Dermatomyositis, Polymyositis
- Being tested
- Active rehabilitation
- Keywords
- rehabilitation, exercise, efficacy, functional status
- Medical subject headings
- Dermatomyositis, Polymyositis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active rehabilitationOther
A program of 12 individual exercise sessions (3 per week during 4 weeks)
| Study group | Role | What they receive |
|---|---|---|
| active rehabilitation | Active comparator | A program of 12 individual exercise sessions (3 per week during 4 weeks) Receives: Other: Active rehabilitation |
| conventional care | No intervention | community based physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAQ score
Measured: 6 month and 1 year after rehabilitation
Secondary outcomes (3)
Quality of life (SF36 score)
Measured: 6 month and 1 year after rehabilitation
MFM(motor function measure)
Measured: 6 month and one year after rehabilitation
muscle strength (MRC manual muscle testing)
Measured: at 6 month and one year after rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startMar 2008
- Primary completionMar 2013
- Study completionDec 2013
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 DermatomyositisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andre Thevenon, Professor, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415219
- Sponsor's protocol ID
- 2007_0712
- Other IDs
- 2007-A00756-47, PHRC 2006/1916, DGS 2007-0440
- Status last verified
- Dec 2014
- First submitted
- 8 Apr 2010
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tiffreau V, Rannou F, Kopciuch F, Hachulla E, Mouthon L, Thoumie P, Sibilia J, Drumez E, Thevenon A. Postrehabilitation Functional Improvements in Patients With Inflammatory Myopathies: The Results of a Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Feb;98(2):227-234. doi: 10.1016/j.apmr.2016.09.125. Epub 2016 Oct 24.
PubMed 27789240
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis
- ClinicalTrials.gov ID
- NCT01415219
- Acronym / sponsor ID
- 2007_0712
- Conditions
- Dermatomyositis, Polymyositis
- Keywords
- rehabilitation, exercise, efficacy, functional status
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Mar 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Aug 2011 (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 purpose of this study is to evaluate the efficacy of an active rehabilitation program on disability and quality of life of patients affected by dermatomyositis and polymyositis.
Detailed description
Dermatomyositis (DM) and polymyositis (PM) are inflammatory disabling neuromuscular disorders. Despite partial benefit of pharmacological treatments, muscle strength, functional status and quality of life remain impaired. Although the use muscle exercises in (DM) and (PM) have been reported, its efficacy on disability and quality of life has not been proved.
Te aim of the study is to evaluate the benefit at mid term (12 months) of an active rehabilitation program administrated to patients affected by PM and DM.
Method: a 3 year prospective, multicentric, randomized controlled trial A program of 12 individual exercise sessions (3 per week during 4 weeks) is compared to conventional care. Patients are followed 12 month after the inclusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active rehabilitation | Active comparator | Other: Active rehabilitationA program of 12 individual exercise sessions (3 per week during 4 weeks) |
| conventional care | No intervention | –community based physiotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of Dermatomyositis ore polymyositis according to the International Myositis Assessment and Clinical Studies Group
- functional impairment (an HAQ score greater than 0.5)
- stability of muscle impairment
- medical insurance
Key exclusion criteria (4 listed)
- no recent inflammatory activity
- other chronic disease
- cognitive impairment
- patients who participated to a rehabilitation program before inclusion
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 |
|---|---|---|
| Active rehabilitationA program of 12 individual exercise sessions (3 per week during 4 weeks) | Other | active rehabilitation |
Primary outcome
HAQ score
Time frame: 6 month and 1 year after rehabilitation
3 secondary outcomes
Quality of life (SF36 score)
Time frame: 6 month and 1 year after rehabilitation
MFM(motor function measure)
Time frame: 6 month and one year after rehabilitation
muscle strength (MRC manual muscle testing)
Time frame: at 6 month and one year after rehabilitation
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 22 Dec 2025.
- Results publication: PubMed 27789240Tiffreau V, Rannou F, Kopciuch F, Hachulla E, Mouthon L, Thoumie P, Sibilia J, Drumez E, Thevenon A. Postrehabilitation Functional Improvements in Patients With Inflammatory Myopathies: The Results of a Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Feb;98(2):227-234. doi: 10.1016/j.apmr.2016.09.125. Epub 2016 Oct 24.
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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.
Andre Thevenon, Professor principal investigator
University Hospital, Lille
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Active rehabilitation in people with Dermatomyositis and Polymyositis, run by University Hospital, Lille at 5 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 4 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 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
HAQ score (time frame: 6 month and 1 year after rehabilitation). 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 NCT01415219, 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 22 Dec 2025.