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
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
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
NCT ID
NCT02502539
First Posted
May 29, 2015
Last Updated
July 25, 2016
Sponsor
University Hospital, Clermont-Ferrand
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
Learn more about this trial
Cellular and Molecular Adaptations to Exercise-induced Inflammatory Response in Children With Autoimmune Diseases
We'll reach out to this number within 24 hrs