Juvenile Idiopathic ArthritisAJIACTNCT04167488
Assessment of Physical Activity Among Juvenile Idiopathic Arthritis Children Performed With Actigraphy
A study testing Actigraphic measurement in people with Juvenile Idiopathic Arthritis, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
This study aims to describe physical activity among juvenile idiopathic arthritis children, according to the disease's and patient's characteristics. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- What is being tested?
- Actigraphic measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 10 Sep 2019to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Juvenile idiopathic arthritis evolving for more than a year
Who cannot join
- intra-articular infiltration performed less than a month ago
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Besançon
Besançon, 25000
Laure Jonyk, Int, laure.jonyk@orange.fr
Claire BALLOT SCHMIT, MD
About this study
This study aims to describe physical activity among juvenile idiopathic arthritis children, according to the disease's and patient's characteristics.
- Conditions
- Juvenile Idiopathic Arthritis
- Being tested
- Actigraphic measurement
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actigraphic measurementDevice
Physical activity assessed with actigraphic device worn during 7 days
| Study group | Role | What they receive |
|---|---|---|
| Actigraphic measurement | Experimental | Not described Receives: Device: Actigraphic measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start10 Sep 2019
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire BALLOT SCHMIT, MD, Principal investigator, CHU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167488
- Sponsor's protocol ID
- P/2019/432
- Acronym
- AJIACT
- Status last verified
- Nov 2019
- First submitted
- 15 Nov 2019
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Physical Activity Among Juvenile Idiopathic Arthritis Children Performed With Actigraphy
- ClinicalTrials.gov ID
- NCT04167488
- Acronym / sponsor ID
- AJIACT / P/2019/432
- Conditions
- Juvenile Idiopathic Arthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to describe physical activity among juvenile idiopathic arthritis children, according to the disease's and patient's characteristics.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Actigraphic measurement | Experimental | Device: Actigraphic measurement |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Juvenile idiopathic arthritis evolving for more than a year
Key exclusion criteria (1 listed)
- intra-articular infiltration performed less than a month ago
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Actigraphic measurementPhysical activity assessed with actigraphic device worn during 7 days | Device | Actigraphic measurement |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire BALLOT SCHMIT, MD principal investigator
CHU de Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actigraphic measurement in people with Juvenile Idiopathic Arthritis, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laure JONYK, Int (0033381218135, laure.jonyk@orange.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity assessment (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.