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Assessment of Physical Activity Among Juvenile Idiopathic Arthritis Children Performed With Actigraphy (AJIACT)

Primary Purpose

Juvenile Idiopathic Arthritis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Actigraphic measurement
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Juvenile Idiopathic Arthritis

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Juvenile idiopathic arthritis evolving for more than a year

Exclusion Criteria:

  • intra-articular infiltration performed less than a month ago

Sites / Locations

  • CHU de BesançonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Actigraphic measurement

Arm Description

Outcomes

Primary Outcome Measures

Physical activity assessment
Physical activity will be measured with actigraphic device and children will be divided into 3 groups of activity levels: low / moderate / high. Low is < or = 1000 counts per minute Moderate is > 1000 counts per minute High is > 2500 per minute

Secondary Outcome Measures

Full Information

First Posted
November 15, 2019
Last Updated
November 15, 2019
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT04167488
Brief Title
Assessment of Physical Activity Among Juvenile Idiopathic Arthritis Children Performed With Actigraphy
Acronym
AJIACT
Official Title
Assessment of Physical Activity Among Juvenile Idiopathic Arthritis Children Performed With Actigraphy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 10, 2019 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to describe physical activity among juvenile idiopathic arthritis children, according to the disease's and patient's characteristics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Actigraphic measurement
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Actigraphic measurement
Intervention Description
Physical activity assessed with actigraphic device worn during 7 days
Primary Outcome Measure Information:
Title
Physical activity assessment
Description
Physical activity will be measured with actigraphic device and children will be divided into 3 groups of activity levels: low / moderate / high. Low is < or = 1000 counts per minute Moderate is > 1000 counts per minute High is > 2500 per minute
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Juvenile idiopathic arthritis evolving for more than a year Exclusion Criteria: intra-articular infiltration performed less than a month ago
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laure JONYK, Int
Phone
0033381218135
Email
laure.jonyk@orange.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire BALLOT SCHMIT, MD
Organizational Affiliation
CHU de Besançon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laure Jonyk, Int
Email
laure.jonyk@orange.fr
First Name & Middle Initial & Last Name & Degree
Claire BALLOT SCHMIT, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessment of Physical Activity Among Juvenile Idiopathic Arthritis Children Performed With Actigraphy

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