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Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis

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ClinicalTrials.gov Identifier: NCT01415219
Recruitment Status : Completed
First Posted : August 11, 2011
Last Update Posted : December 18, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

April 8, 2010
August 11, 2011
December 18, 2014
March 2008
March 2013   (Final data collection date for primary outcome measure)
HAQ score [ Time Frame: 6 month and 1 year after rehabilitation ]
Same as current
Complete list of historical versions of study NCT01415219 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis
Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Dermatomyositis
  • Polymyositis
Other: Active rehabilitation
A program of 12 individual exercise sessions (3 per week during 4 weeks)
  • Active Comparator: active rehabilitation
    A program of 12 individual exercise sessions (3 per week during 4 weeks)
    Intervention: Other: Active rehabilitation
  • No Intervention: conventional care
    community based physiotherapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
Same as current
December 2013
March 2013   (Final data collection date for primary outcome measure)

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:

  • no recent inflammatory activity
  • other chronic disease
  • cognitive impairment
  • patients who participated to a rehabilitation program before inclusion
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01415219
2007_0712
2007-A00756-47 ( Other Identifier: ID-RCB number, AFSSAPS )
PHRC 2006/1916 ( Other Identifier: DHOS )
DGS 2007-0440 ( Other Identifier: AFSSAPS )
Yes
Not Provided
Not Provided
University Hospital, Lille
University Hospital, Lille
Not Provided
Principal Investigator: Andre Thevenon, Professor University Hospital, Lille
University Hospital, Lille
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP