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

Not Applicable

• Conditions: Juvenile Idiopathic Arthritis
• Interventions: Procedure: Controlled physical activity

• Registration Number: NCT02502539
• Lead Sponsor: 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.

Detailed Description

Feasibility study

Study Timeline

• Study First Submitted: 2015-05-29
• Study Start: 2015-07
• Study First Submitted QC: 2015-07-17
• Study First Posted: 2015-07-20
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-25
• Last Update Posted: 2016-07-26
• Primary Completion: 2016-10
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percent change	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

Name	Time	Method
pain (VAS)	at day 1	to assess slipping quality
locomotors function (CHAQ)	at day 1	to assess slipping quality
swelling of knee	at day 1	to assess slipping quality
rate of miRNA	at day 1	to assess slipping quality
plasma level of melatonin	at day 1	to assess slipping quality
sitfness of knee	at day 1	to assess slipping quality

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France