Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis

University Hospital, Lille

Status and phase: Completed; Phase 2

Conditions: Dermatomyositis; Polymyositis

Treatments: Other: Active rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT01415219

2007_0712

2007-A00756-47 (Other Identifier)

PHRC 2006/1916 (Other Identifier)

DGS 2007-0440 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

active rehabilitation

Active Comparator group

Description:

A program of 12 individual exercise sessions (3 per week during 4 weeks)

Treatment:

Other: Active rehabilitation

conventional care

No Intervention group

Description:

community based physiotherapy