Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis

December 17, 2014 updated by: University Hospital, Lille
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75679
        • Hopital Cochin
      • Paris, France, 75651
        • GH Pitié Salpêtrière
      • Paris, France, 75571
        • Hôpital ROTSCHILD
      • Rouen, France, 76031
        • Centre Hospitalier Universitaire de Rouen
    • Nord Pas de Calais
      • Lille, Nord Pas de Calais, France, 59037
        • University Hospital, Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HAQ score
Time Frame: 6 month and 1 year after rehabilitation
6 month and 1 year after rehabilitation

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life (SF36 score)
Time Frame: 6 month and 1 year after rehabilitation
6 month and 1 year after rehabilitation
MFM(motor function measure)
Time Frame: 6 month and one year after rehabilitation
6 month and one year after rehabilitation
muscle strength (MRC manual muscle testing)
Time Frame: at 6 month and one year after rehabilitation
at 6 month and one year after rehabilitation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Andre Thevenon, Professor, University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

April 8, 2010

First Submitted That Met QC Criteria

August 10, 2011

First Posted (Estimate)

August 11, 2011

Study Record Updates

Last Update Posted (Estimate)

December 18, 2014

Last Update Submitted That Met QC Criteria

December 17, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007_0712
  • 2007-A00756-47 (Other Identifier: ID-RCB number, AFSSAPS)
  • PHRC 2006/1916 (Other Identifier: DHOS)
  • DGS 2007-0440 (Other Identifier: AFSSAPS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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