Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by University Hospital, Lille.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Hospital, Lille
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01415219
First received: April 8, 2010
Last updated: June 14, 2012
Last verified: January 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Dermatomyositis Polymyositis |
Other: Active rehabilitation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis |
Resource links provided by NLM:
Further study details as provided by University Hospital, Lille:
Primary Outcome Measures:
- HAQ score [ Time Frame: 6 month and 1 year after rehabilitation ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Quality of life (SF36 score) [ Time Frame: 6 month and 1 year after rehabilitation ] [ Designated as safety issue: No ]
- MFM(motor function measure) [ Time Frame: 6 month and one year after rehabilitation ] [ Designated as safety issue: No ]
- muscle strength (MRC manual muscle testing) [ Time Frame: at 6 month and one year after rehabilitation ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01415219
Contacts
| Contact: Andre Thevenon, Pr | 33 (0)3 20 44 58 30 | athevenon@chru-lille.fr |
Locations
| France | |
| University Hospital, Lille | Recruiting |
| Lille, Nord Pas de Calais, France, 59037 | |
| Contact: Vincent Tiffreau, Dr 33 (0)3 20 44 58 08 vincent.tiffreau@chru-lille.fr | |
| Sub-Investigator: Vincent Tiffreau, Dr | |
| Sub-Investigator: Eric Hachulla, Pr | |
| Hopital Cochin | Recruiting |
| Paris, France, 75679 | |
| Contact: Francois Rannou, pr francois.rannou@cch.aphp.fr | |
| Sub-Investigator: Luc Mouthon, Pr | |
| Sub-Investigator: Loic Guillevin, Pr | |
| Hopital Rotschild | Recruiting |
| Paris, France, 75571 | |
| Contact: philippe Thoumies, Pr philippe.thoumie@rth.ap-hop-paris.fr | |
| Sub-Investigator: Philippe Thoumies, Pr | |
| GH Pitié Salpétrière | Recruiting |
| Paris, France, 75651 | |
| Contact: Serge Herson, Pr | |
| Sub-Investigator: Olivier Benveniste, Dr | |
| Centre hospitalier universitaire de Rouen | Recruiting |
| Rouen, France, 76031 | |
| Contact: Françoise Beuret-Blanquart, Pr francoise.beuret@ugecam-normandie.fr | |
| Sub-Investigator: Isabelle Marie, Pr | |
Sponsors and Collaborators
University Hospital, Lille
Investigators
| Principal Investigator: | Andre Thevenon, Professor | University Hospital, Lille |
More Information
No publications provided
| Responsible Party: | University Hospital, Lille |
| ClinicalTrials.gov Identifier: | NCT01415219 History of Changes |
| Other Study ID Numbers: | 2007-A00756-47, 2007/0712, PHRC 2006/1916, DGS 2007-0440 |
| Study First Received: | April 8, 2010 |
| Last Updated: | June 14, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Lille:
|
rehabilitation exercise efficacy functional status |
Additional relevant MeSH terms:
|
Dermatomyositis Polymyositis Myositis Muscular Diseases Musculoskeletal Diseases |
Neuromuscular Diseases Nervous System Diseases Connective Tissue Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 22, 2013