Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01415219

Enrollment

Registered

2011-08-11

Start date

2008-03-31

Completion date

2013-12-31

Last updated

2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatomyositis, Polymyositis

Keywords

rehabilitation, exercise, efficacy, functional status

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.

Interventions

OTHERActive rehabilitation

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
HAQ score	6 month and 1 year after rehabilitation

Secondary

Measure	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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026