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Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis

NCT ID: NCT01415219

Last Updated: 2014-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Dermatomyositis Polymyositis

Keywords

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rehabilitation exercise efficacy functional status

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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active rehabilitation

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

Group Type ACTIVE_COMPARATOR

Active rehabilitation

Intervention Type OTHER

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

conventional care

community based physiotherapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Active rehabilitation

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andre Thevenon, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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University Hospital, Lille

Lille, Hauts-de-France, France

Site Status

Hopital Rotschild

Paris, , France

Site Status

GH Pitié Salpétrière

Paris, , France

Site Status

Hopital Cochin

Paris, , France

Site Status

Centre hospitalier universitaire de Rouen

Rouen, , France

Site Status

Countries

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France

References

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Tiffreau V, Rannou F, Kopciuch F, Hachulla E, Mouthon L, Thoumie P, Sibilia J, Drumez E, Thevenon A. Postrehabilitation Functional Improvements in Patients With Inflammatory Myopathies: The Results of a Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Feb;98(2):227-234. doi: 10.1016/j.apmr.2016.09.125. Epub 2016 Oct 24.

Reference Type DERIVED
PMID: 27789240 (View on PubMed)

Other Identifiers

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2007-A00756-47

Identifier Type: OTHER

Identifier Source: secondary_id

PHRC 2006/1916

Identifier Type: OTHER

Identifier Source: secondary_id

DGS 2007-0440

Identifier Type: OTHER

Identifier Source: secondary_id

2007_0712

Identifier Type: -

Identifier Source: org_study_id