NCT04167488

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 19, 2019

Status Verified

November 1, 2019

Enrollment Period

3 months

First QC Date

November 15, 2019

Last Update Submit

November 15, 2019

Conditions

Juvenile Idiopathic Arthritis

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 7

Study Arms (1)

Actigraphic measurement

EXPERIMENTAL
Device: Actigraphic measurement

Interventions

Actigraphic measurementDEVICE

Physical activity assessed with actigraphic device worn during 7 days

Actigraphic measurement

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Juvenile idiopathic arthritis evolving for more than a year

You may not qualify if:

  • intra-articular infiltration performed less than a month ago

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Besançon

Besançon, 25000, France

RECRUITING

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Claire BALLOT SCHMIT, MD

    CHU de Besançon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laure JONYK, Int

CONTACT

0033381218135laure.jonyk@orange.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2019

First Posted

November 19, 2019

Study Start

September 10, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

November 19, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)