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Cellular and Molecular Adaptations to Exercise-induced Inflammatory Response in Children With Autoimmune Diseases (AJI-APA)

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ClinicalTrials.gov Identifier: NCT02502539
Recruitment Status : Unknown
Verified July 2016 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : July 20, 2015
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:
Juvenile idiopathic arthritis (JIA) is a chronic disease characterized by persistent joint inflammation. The immune system disruption that leads to overproduction of pro-inflammatory cytokines (TNF-α, IL-1, IL-6) is a cascade of events on different levels—some molecular, some cellular, and some systemic. Our objective is to identify the mechanisms through which physical activity is liable to mediate inflammatory balance in autoimmune disease settings, and specifically in JIA patients.

Condition or disease Intervention/treatment Phase
Juvenile Idiopathic Arthritis Procedure: Controlled physical activity Not Applicable

Detailed Description:
Feasibility study

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cellular and Molecular Adaptations to Exercise-induced Inflammatory Response in Children With Autoimmune Diseases
Study Start Date : July 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : January 2017


Arm Intervention/treatment
Experimental: autoimmune disease
to identify the mechanisms through which physical activity is liable to mediate inflammatory balance in autoimmune disease settings, and specifically in JIA patients.
Procedure: Controlled physical activity



Primary Outcome Measures :
  1. Percent change [ Time Frame: AT DAY 1 ]
    Percent change, before and after a controlled session of physical activity session, of serum and secretion kinetics of IL-6 and its soluble receptors (sIL- 6R and sgp130)


Secondary Outcome Measures :
  1. pain (VAS) [ Time Frame: at day 1 ]
    to assess slipping quality

  2. locomotors function (CHAQ) [ Time Frame: at day 1 ]
    to assess slipping quality

  3. swelling of knee [ Time Frame: at day 1 ]
    to assess slipping quality

  4. rate of miRNA [ Time Frame: at day 1 ]
    to assess slipping quality

  5. plasma level of melatonin [ Time Frame: at day 1 ]
    to assess slipping quality

  6. sitfness of knee [ Time Frame: at day 1 ]
    to assess slipping quality



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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children between 8 and 12 years
  • Tanner stage < T2
  • polyarthritis, oligoarthritis and ERA sub-type of JIA
  • Stable disease during 3 months before starting study

Exclusion Criteria:

  • Infection
  • Fever
  • Anti-IL6 treatment
  • More than 6h per week of physical activity
  • Systemic corticosteroid treatment during the 3 months before starting study
  • Systemic JIA
  • JIA not mastered by treatments
  • Other autoimmunity or auto-inflammatory diseases
  • Participation in another clinical research protocol

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): NCT02502539


Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Etienne MERLIN         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Etienne MERLIN CHU ESTAING

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02502539     History of Changes
Other Study ID Numbers: CHU-0234
2015-A00607-42 ( Registry Identifier: 2015-A00607-42 )
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016

Keywords provided by University Hospital, Clermont-Ferrand:
Juvenile idiopathic arthritis
Physical exercise
Pro-anti-inflammatory balance
Interleukins
miRNA
Calgranulins

Additional relevant MeSH terms:
Arthritis
Autoimmune Diseases
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Immune System Diseases
Rheumatic Diseases
Connective Tissue Diseases