Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis

Phase 2

Completed

• Conditions: Dermatomyositis; Polymyositis
• Interventions: Other: Active rehabilitation

• Registration Number: NCT01415219
• Lead Sponsor: University Hospital, Lille

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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2010-04-08
• Study First Submitted QC: 2011-08-10
• Study First Posted: 2011-08-11
• Primary Completion: 2013-03
• Study Completion: 2013-12
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-17
• Last Update Posted: 2014-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
active rehabilitation	Active rehabilitation	A program of 12 individual exercise sessions (3 per week during 4 weeks)

Primary Outcome Measures

Name	Time	Method
HAQ score	6 month and 1 year after rehabilitation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

University Hospital, Lille; 🇫🇷 Lille, Nord Pas de Calais, France

Hopital Rotschild; 🇫🇷 Paris, France

GH Pitié Salpétrière; 🇫🇷 Paris, France

Hopital Cochin; 🇫🇷 Paris, France

Centre hospitalier universitaire de Rouen; 🇫🇷 Rouen, France