Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Dermatomyositis
- Sponsor
- University Hospital, Lille
- Enrollment
- 80
- Locations
- 5
- Primary Endpoint
- HAQ score
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
HAQ score
Time Frame: 6 month and 1 year after rehabilitation
Secondary Outcomes
- muscle strength (MRC manual muscle testing)(at 6 month and one year after rehabilitation)
- Quality of life (SF36 score)(6 month and 1 year after rehabilitation)
- MFM(motor function measure)(6 month and one year after rehabilitation)