Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis

Dermatomyositis Clinical Trial

Official title:

Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01415219
• Other study ID #: 2007_0712
• Secondary ID: 2007-A00756-47PH
• Status: Completed
• Phase: Phase 2
• First received: April 8, 2010
• Last updated: December 17, 2014
• Start date: March 2008
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatomyositis
• Polymyositis

Intervention

Other:
• Active rehabilitation
A program of 12 individual exercise sessions (3 per week during 4 weeks)

Locations

Country	Name	City	State
France	University Hospital, Lille	Lille	Nord Pas de Calais
France	GH Pitié Salpétrière	Paris
France	Hopital Cochin	Paris
France	Hopital Rotschild	Paris
France	Centre hospitalier universitaire de Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HAQ score		6 month and 1 year after rehabilitation	No
Secondary	Quality of life (SF36 score)		6 month and 1 year after rehabilitation	No
Secondary	MFM(motor function measure)		6 month and one year after rehabilitation	No
Secondary	muscle strength (MRC manual muscle testing)		at 6 month and one year after rehabilitation	No