- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04167488
Assessment of Physical Activity Among Juvenile Idiopathic Arthritis Children Performed With Actigraphy (AJIACT)
November 15, 2019 updated by: Centre Hospitalier Universitaire de Besancon
This study aims to describe physical activity among juvenile idiopathic arthritis children, according to the disease's and patient's characteristics.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
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
-
-
-
Besançon, France, 25000
- Recruiting
- CHU de BESANCON
-
Contact:
- Laure Jonyk, Int
- Email: laure.jonyk@orange.fr
-
Principal Investigator:
- Claire BALLOT SCHMIT, MD
-
-
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
4 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Juvenile idiopathic arthritis evolving for more than a year
Exclusion Criteria:
- intra-articular infiltration performed less than a month ago
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: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Actigraphic measurement
|
Physical activity assessed with actigraphic device worn during 7 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity assessment
Time Frame: Day 7
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Claire BALLOT SCHMIT, MD, CHU de BESANCON
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 (ACTUAL)
September 10, 2019
Primary Completion (ANTICIPATED)
December 1, 2019
Study Completion (ANTICIPATED)
December 1, 2019
Study Registration Dates
First Submitted
November 15, 2019
First Submitted That Met QC Criteria
November 15, 2019
First Posted (ACTUAL)
November 19, 2019
Study Record Updates
Last Update Posted (ACTUAL)
November 19, 2019
Last Update Submitted That Met QC Criteria
November 15, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P/2019/432
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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