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NCT Number: NCT01415219

Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis

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.

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Key information

Conditions

Dermatomyositis Behavior Connective Tissue Diseases Motor Activity Muscular Diseases Musculoskeletal Diseases Myositis Nervous System Diseases Neuromuscular Diseases Polymyositis Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital, Lille, Lille, Hauts-de-France, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Rehabilitation

Other

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

Primary outcomes

  1. HAQ score

    Time frame: 6 month and 1 year after rehabilitation

Secondary outcomes

  1. Quality of life (SF36 score)

    Time frame: 6 month and 1 year after rehabilitation

  2. MFM(motor function measure)

    Time frame: 6 month and one year after rehabilitation

  3. muscle strength (MRC manual muscle testing)

    Time frame: at 6 month and one year after rehabilitation

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Aug 11, 2011
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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