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

Study Overview
=================
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

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

Conditions
-----------------
Juvenile Idiopathic Arthritis

Intervention / Treatment
-----------------
* Procedure: Controlled physical activity


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: autoimmune disease<br>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<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | AT DAY 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain (VAS) | to assess slipping quality | at day 1 | 
| locomotors function (CHAQ) | to assess slipping quality | at day 1 | 
| swelling of knee | to assess slipping quality | at day 1 | 
| rate of miRNA | to assess slipping quality | at day 1 | 
| plasma level of melatonin | to assess slipping quality | at day 1 | 
| sitfness of knee | to assess slipping quality | at day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical exercise, Juvenile idiopathic arthritis, Pro-anti-inflammatory balance, Interleukins, miRNA, Calgranulins