Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis

Conditions
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Dermatomyositis, Polymyositis

Intervention / Treatment
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* Other: Active rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active rehabilitation<br>A program of 12 individual exercise sessions (3 per week during 4 weeks) | Other: Active rehabilitation<br>* A program of 12 individual exercise sessions (3 per week during 4 weeks)<br>|
| No Intervention: conventional care<br>community based physiotherapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAQ score |  | 6 month and 1 year after rehabilitation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation, exercise, efficacy, functional status