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Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis

Primary Purpose

Dermatomyositis, Polymyositis

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Active rehabilitation
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatomyositis focused on measuring rehabilitation, exercise, efficacy, functional status

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital, Lille
  • Hopital Rotschild
  • GH Pitié Salpétrière
  • Hopital Cochin
  • Centre hospitalier universitaire de Rouen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

active rehabilitation

conventional care

Arm Description

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

community based physiotherapy

Outcomes

Primary Outcome Measures

HAQ score

Secondary Outcome Measures

Quality of life (SF36 score)
MFM(motor function measure)
muscle strength (MRC manual muscle testing)

Full Information

First Posted
April 8, 2010
Last Updated
December 17, 2014
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT01415219
Brief Title
Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis
Official Title
Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatomyositis, Polymyositis
Keywords
rehabilitation, exercise, efficacy, functional status

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active rehabilitation
Arm Type
Active Comparator
Arm Description
A program of 12 individual exercise sessions (3 per week during 4 weeks)
Arm Title
conventional care
Arm Type
No Intervention
Arm Description
community based physiotherapy
Intervention Type
Other
Intervention Name(s)
Active rehabilitation
Intervention Description
A program of 12 individual exercise sessions (3 per week during 4 weeks)
Primary Outcome Measure Information:
Title
HAQ score
Time Frame
6 month and 1 year after rehabilitation
Secondary Outcome Measure Information:
Title
Quality of life (SF36 score)
Time Frame
6 month and 1 year after rehabilitation
Title
MFM(motor function measure)
Time Frame
6 month and one year after rehabilitation
Title
muscle strength (MRC manual muscle testing)
Time Frame
at 6 month and one year after rehabilitation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre Thevenon, Professor
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Lille
City
Lille
State/Province
Nord Pas de Calais
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Rotschild
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
GH Pitié Salpétrière
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75679
Country
France
Facility Name
Centre hospitalier universitaire de Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
27789240
Citation
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.
Results Reference
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Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis

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