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Effects of a Personalized Standardized Rehabilitation Program in Systemic Sclerosis

Study acronym: SCLEREDUC
StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Publications: details revised at 1 of 3 entriesv11
  2. Publications: 2 to 3 Collaborators expanded, about 5 wordsv10 Show 1 more changeShow less
    • Collaborators expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  3. Publications: details revised at 1 of 2 entriesv9
  4. 2 versions Re-verified since Apr 11, 2014, no change to tracked fieldsv7-v8
  5. Trial status: Active, Not Recruiting to Completedv6
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  1. Completion date: Dec 2012 to Jan 2014v5
  2. Trial status: Recruiting to Active, Not Recruiting Primary completion date: Dec 2011 · Completion date: Jun 2007 to Dec 2012 · Eligibility criteria expanded, about 120 words · 3 morev4 Show 6 more changesShow less
    • Primary completion date: Dec 2011
    • Completion date: Jun 2007 to Dec 2012
    • Eligibility criteria expanded, about 120 words
    • Secondary endpoints: 4 to 10
    • Site details revised
    • Study arms: 0 to 2

    See this version in full on ClinicalTrials.gov ↗

  3. Completion date: Mar 2007 to Jun 2007v3
  4. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00318188
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators: URC-CIC Paris Descartes Necker Cochin
Conditions Systemic Scleroderma
Enrollment 220 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov