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CompletedNCT01415219Updated Dec 22, 2025

Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis

A Phase 2 interventional study of Active rehabilitation in Dermatomyositis and Polymyositis, sponsored by University Hospital, Lille. Completed at 5 sites in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-22.

Sponsored by University Hospital, Lille · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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 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.

02

Conditions studied

  • Dermatomyositis
  • Polymyositis

Keywords

  • rehabilitation
  • exercise
  • efficacy
  • functional status
03

In context

Dermatomyositis

184 studies on the registry are indexed under Dermatomyositis; 63 are open to participants now.

This study's enrollment of 80 is above the median of 35 across 130 interventional studies indexed under Dermatomyositis.

Browse Dermatomyositis studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • no recent inflammatory activity
  • other chronic disease
  • cognitive impairment
  • patients who participated to a rehabilitation program before inclusion
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    active rehabilitation

    A program of 12 individual exercise sessions (3 per week during 4 weeks)

    Other: Active rehabilitation

  • No intervention
    conventional care

    community based physiotherapy

Interventions

  • OtherActive rehabilitation

    A program of 12 individual exercise sessions (3 per week during 4 weeks)

06

What researchers measure

Primary outcomes

  1. HAQ score

    Time frame: 6 month and 1 year after rehabilitation

Secondary outcomes

  1. Quality of life (SF36 score)

    Time frame: 6 month and 1 year after rehabilitation

  2. MFM(motor function measure)

    Time frame: 6 month and one year after rehabilitation

  3. muscle strength (MRC manual muscle testing)

    Time frame: at 6 month and one year after rehabilitation

07

Study locations

5 sites
  • University Hospital, Lille
    Lille, Hauts-de-France 59037, France
  • Hopital Rotschild
    Paris, 75571, France
  • GH Pitié Salpétrière
    Paris, 75651, France
  • Hopital Cochin
    Paris, 75679, France
  • Centre hospitalier universitaire de Rouen
    Rouen, 76031, France
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01415219
Responsible party
Sponsor
First posted
Aug 11, 2011
Start date
Mar 2008
Primary completion
Mar 2013
Completion
Dec 2013
Last update
Dec 22, 2025

Study contacts

Andre Thevenon, Professor
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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