Cellular and Molecular Adaptations to Exercise-induced In... | NCT02502539

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

NCT02502539

Sponsor

University Hospital, Clermont-Ferrand

Status

Unknown status

Last Update Posted

Jul 26, 2016Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Juvenile Idiopathic Arthritis

Interventions

Controlled physical activity

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2015-A00607-42	Registry Identifier	2015-A00607-42

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Oct 2016Estimated

Completion Date

Jan 2017Estimated

First Submitted Date

May 29, 2015

First Submission Date that Met QC Criteria

Jul 17, 2015

First Posted Date

Jul 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2016

Last Update Posted Date

Jul 26, 2016Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
autoimmune disease	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Controlled physical activity	Procedure		autoimmune disease

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
pain (VAS)	to assess slipping quality	at day 1
locomotors function (CHAQ)	to assess slipping quality	at day 1

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patrick LACARIN	Contact	04 73 75 11 95		placarin@chu-clermontferrand.fr

Overall Officials

Name	Affiliation	Role
Etienne MERLIN	CHU ESTAING	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Clermont-Ferrand	Recruiting	Clermont-Ferrand		63003	France

Condition Browse Module

MeSH Terms

ID	Term
D001171	Arthritis, Juvenile
D009043	Motor Activity

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided