Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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         
GH Pitié Salpétrière Recruiting
Paris, France, 75651
Contact: Serge Herson, Pr         
Sub-Investigator: Olivier Benveniste, Dr         
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         
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
Connective Tissue Diseases
Muscular Diseases
Musculoskeletal Diseases
Myositis
Nervous System Diseases
Neuromuscular Diseases
Skin Diseases

ClinicalTrials.gov processed this record on November 20, 2014