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

Primary Purpose

Juvenile Idiopathic Arthritis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Controlled physical activity
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Juvenile Idiopathic Arthritis focused on measuring Juvenile idiopathic arthritis, Physical exercise, Pro-anti-inflammatory balance, Interleukins, miRNA, Calgranulins

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

autoimmune disease

Arm Description

to identify the mechanisms through which physical activity is liable to mediate inflammatory balance in autoimmune disease settings, and specifically in JIA patients.

Outcomes

Primary Outcome Measures

Percent change
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

pain (VAS)
to assess slipping quality
locomotors function (CHAQ)
to assess slipping quality
swelling of knee
to assess slipping quality
rate of miRNA
to assess slipping quality
plasma level of melatonin
to assess slipping quality
sitfness of knee
to assess slipping quality

Full Information

First Posted
May 29, 2015
Last Updated
July 25, 2016
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT02502539
Brief Title
Cellular and Molecular Adaptations to Exercise-induced Inflammatory Response in Children With Autoimmune Diseases
Acronym
AJI-APA
Official Title
Cellular and Molecular Adaptations to Exercise-induced Inflammatory Response in Children With Autoimmune Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

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.
Detailed Description
Feasibility study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis
Keywords
Juvenile idiopathic arthritis, Physical exercise, Pro-anti-inflammatory balance, Interleukins, miRNA, Calgranulins

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
autoimmune disease
Arm Type
Experimental
Arm Description
to identify the mechanisms through which physical activity is liable to mediate inflammatory balance in autoimmune disease settings, and specifically in JIA patients.
Intervention Type
Procedure
Intervention Name(s)
Controlled physical activity
Primary Outcome Measure Information:
Title
Percent change
Description
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)
Time Frame
AT DAY 1
Secondary Outcome Measure Information:
Title
pain (VAS)
Description
to assess slipping quality
Time Frame
at day 1
Title
locomotors function (CHAQ)
Description
to assess slipping quality
Time Frame
at day 1
Title
swelling of knee
Description
to assess slipping quality
Time Frame
at day 1
Title
rate of miRNA
Description
to assess slipping quality
Time Frame
at day 1
Title
plasma level of melatonin
Description
to assess slipping quality
Time Frame
at day 1
Title
sitfness of knee
Description
to assess slipping quality
Time Frame
at day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Etienne MERLIN
Organizational Affiliation
CHU ESTAING
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Etienne MERLIN

12. IPD Sharing Statement

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Cellular and Molecular Adaptations to Exercise-induced Inflammatory Response in Children With Autoimmune Diseases

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