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Effects of a Personalized Standardized Rehabilitation Program in Systemic Sclerosis (SCLEREDUC)

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ClinicalTrials.gov Identifier: NCT00318188
Recruitment Status : Completed
First Posted : April 26, 2006
Last Update Posted : July 18, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
Systemic sclerosis (SSc) is a connective-tissue disease characterized by excessive collagen deposition, vascular hyper-reactivity and obliterative microvascular phenomena leading to disability, handicap, and worsening of quality of life. Pharmacological treatments are mainly used for vascular involvement. To date, no pharmacological treatment have been shown to be effective for the fibrosis leading to skin, tendon, and joint disability. Our hypothesis is that rehabilitation could be an interesting non pharmacological treatment in order to decrease the handicap of SSc patients. Our objective is to evaluate the effect of a personalized standardized rehabilitation program on the quality of life of SSc patients in a multicentric randomized controlled trial. This trial will compare a personalized standardized rehabilitation program to the usual non pharmacological treatment. The primary outcome measure will be the HAQ DI (Health Assessment Questionnaire Disability Index). A Zelen design will be used for this study.

Condition or disease Intervention/treatment
Systemic Scleroderma Procedure: standardized reeducation and readaptation program

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Effects of a Personalized Standardized Rehabilitation Program on the Quality of Life of Patients With Systemic Sclerosis Patients : a Randomized Controlled Trial
Study Start Date : September 2005
Primary Completion Date : December 2011
Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Intervention group
The patients in this group will do a personalized standardized rehabilitation program on the quality of life.
Procedure: standardized reeducation and readaptation program
No Intervention: Control group
Habitual care

Outcome Measures

Primary Outcome Measures :
  1. HAQ DI:Health Assessment questionnaire disability index [ Time Frame: at 12 months ]
    Health Assessment questionnaire disability index

Secondary Outcome Measures :
  1. Mac Tar (Mc Master Toronto Arthritis questionnaire) [ Time Frame: at 12 months ]
    Mc Master Toronto Arthritis questionnaire

  2. S-HAQ ( scleroderma-modified health assessment questionnaire) [ Time Frame: at 12 months ]
    Scleroderma-modified health assessment questionnaire

  3. SF 36 [ Time Frame: at 12 months ]
  4. Kapandji modified index [ Time Frame: at 12 months ]
  5. Rodnan score [ Time Frame: at 12 months ]
  6. Hand Cochin Function Scale [ Time Frame: at 12 months ]
  7. Pain [ Time Frame: at 12 months ]
  8. Mouth opening [ Time Frame: at 12 months ]
  9. Forced expiratory volume (FEV) [ Time Frame: at 12 months ]
  10. Satisfaction of clinical condition [ Time Frame: at 12 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men or women aged from 18 years or more, with diagnostic of SSc considering the ACR and/or Leroy and Medsger's criteria.
  • HAQ greater than or equal to 0.5
  • A perception of limitation of mouth opening and/or at least one limitation in range of motion due to illness
  • Good understanding of the French language

Exclusion Criteria :

  • Associated chronic handicap diseases (stroke, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease, amputated ....)
  • Any underlying disease that may be incompatible with the management, discovery at the inclusion visit
  • Cognitive problems making it impossible to assess the primary outcome measure
  • Patients with a standardized rehabilitation program within 6 months prior to inclusion
  • Impairment of comprehension or expression of the French language
  • Patients participating in another clinical trial or participated in another clinical trial in the previous 3 months.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00318188

Reeducation and readaptation Department
Paris, France, 75679
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Study Chair: Serge POIREAUDEAU, MD-PhD Cochin Hospital
More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00318188     History of Changes
Other Study ID Numbers: AOM04023
First Posted: April 26, 2006    Key Record Dates
Last Update Posted: July 18, 2014
Last Verified: July 2014

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Intensive care reeducation, readaptation

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases