Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis
4 other identifiers
interventional
80
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2008
Longer than P75 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 8, 2010
CompletedFirst Posted
Study publicly available on registry
August 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedDecember 22, 2025
December 1, 2014
5 years
April 8, 2010
December 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HAQ score
6 month and 1 year after rehabilitation
Secondary Outcomes (3)
Quality of life (SF36 score)
6 month and 1 year after rehabilitation
MFM(motor function measure)
6 month and one year after rehabilitation
muscle strength (MRC manual muscle testing)
at 6 month and one year after rehabilitation
Study Arms (2)
active rehabilitation
ACTIVE COMPARATORA program of 12 individual exercise sessions (3 per week during 4 weeks)
conventional care
NO INTERVENTIONcommunity based physiotherapy
Interventions
A program of 12 individual exercise sessions (3 per week during 4 weeks)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- no recent inflammatory activity
- other chronic disease
- cognitive impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
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
Related Publications (1)
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.
PMID: 27789240RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andre Thevenon, Professor
University Hospital, Lille
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2010
First Posted
August 11, 2011
Study Start
March 1, 2008
Primary Completion
March 1, 2013
Study Completion
December 1, 2013
Last Updated
December 22, 2025
Record last verified: 2014-12