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

July 25, 2016 updated by: University Hospital, Clermont-Ferrand
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Feasibility study

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • CHU de Clermont-Ferrand
        • Principal Investigator:
          • Etienne MERLIN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
AT DAY 1

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Etienne MERLIN, CHU Estaing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

May 29, 2015

First Submitted That Met QC Criteria

July 17, 2015

First Posted (Estimate)

July 20, 2015

Study Record Updates

Last Update Posted (Estimate)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0234
  • 2015-A00607-42 (Registry Identifier: 2015-A00607-42)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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