Clinical trial NCT01415219: Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis
Official title: Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dermatomyositis
Polymyositis
Keywords: rehabilitation
exercise
efficacy
functional status
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2011-08-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: HAQ score
timeFrame: 6 month and 1 year after rehabilitation
Secondary outcomes:
measure: Quality of life (SF36 score)
timeFrame: 6 month and 1 year after rehabilitation
measure: MFM(motor function measure)
timeFrame: 6 month and one year after rehabilitation
measure: muscle strength (MRC manual muscle testing)
timeFrame: at 6 month and one year after rehabilitation
Other outcomes:
Locations:
city: Lille
country: France
facility: University Hospital, Lille
state: Nord Pas de Calais
city: Paris
country: France
facility: Hopital Rotschild
city: Paris
country: France
facility: GH Pitié Salpétrière
city: Paris
country: France
facility: Hopital Cochin
city: Rouen
country: France
facility: Centre hospitalier universitaire de Rouen
Study officials:
affiliation: University Hospital, Lille
name: Andre Thevenon, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.