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Juvenile Idiopathic ArthritisATHLETIQUENCT05572424

Interest of an Adapted Physical Activity (APA) Program Among Patients With Juvenile Idiopathic Arthritis: a Feasibility and Efficacy Preliminary Study

A study testing Adaptated Physical Activity (APA) + pedometer watch in people with Juvenile Idiopathic Arthritis, run by Centre Hospitalier Universitaire de Besancon at 3 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The Juvenile Idiopathic Arthritis (JIA) affects joints mobility and leads pain, impacting the practice of physical activities. Adapted Physical Activities are rehabilitation methods increasingly used, but additional studies are needed to define the nature of the physical activity for patients with JIA. Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Juvenile Idiopathic Arthritis
What is being tested?
Adaptated Physical Activity (APA) + pedometer watch
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesFrance
Study dates
5 Jul 2023to Oct 2024
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 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children (boys and girls) aged 6 to 17 years
  • Children with juvenile idiopathic arthritis (JIA) : oligoarticular, polyarticular, psoriatic or enthesitis-related arthritis, with more than one year of disease progression
  • Children on stable conventional or biotherapy 3 months prior to inclusion
  • Children with a computer/tablet/connected phone that allows them to follow adapted physical activities sessions online
  • If sexually active adolescents, use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double barrier method, contraceptive patches)
  • Signed informed consent to participate indicating that the parent(s) understand the purpose and procedures required for the study and agree(s) that their child(ren) will participate in the study and abide by the requirements and restrictions of the study
Show all 14Show fewer
  • Affiliation with a French social security system or beneficiary of such a system.
  • Non-inclusion criteria:
  • Treatment by intra-articular infiltration less than 1 month old (immobilization required after the procedure and temporary cessation of physical activity unavoidable)
  • Contraindications to physical activity
  • Subject unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator
  • Subject without health insurance
  • Pregnant adolescent
  • Subject in the exclusion period of another study or is the "national volunteer register"

Who cannot join

  • Intra-articular infiltration treatment during the 3 months of the adapted physical activity (APA) program (except for the temporomandibular joint)
  • Change of biotherapy during the 3 months of the APA program if the treatment is ineffective
  • Physical inability to engage in physical activity, unrelated to JIA, during the 3-month of the APA program

Trial locations and contacts

3 sites in 1 country.

Claire BALLOT-SCHMIT, MD contact

0381219139

cballotschmit@chu-besancon.fr

Stéphanie PY, PhD contact

0381218993

s1py@chu-besancon.fr

France3 sites, 3 recruiting

  • CHU de Besançon

    Besançon, 25000

    Stéphanie Py, PhD, s1py@chu-besancon.fr

    Claire Ballot-Schmit, MD

    Recruiting

  • Hospices Civils de Lyon

    Lyon, 69000

    Samira Plassart, PhD, samira.plassart@chu-lyon.fr

    Audrey Laurent, MD

    Recruiting

  • Hôpital Nord Franche-Comté

    Trévenans

    Anne Lohse, MD, anne.lohse@hnfc.fr

    Anne Lohse, MD

    Recruiting

Other trials in France

About this study

The Juvenile Idiopathic Arthritis (JIA) affects joints mobility and leads pain, impacting the practice of physical activities. Adapted Physical Activities are rehabilitation methods increasingly used, but additional studies are needed to define the nature of the physical activity for patients with JIA. The ATHLETIQUE project aims to evaluate the impact of a program integrating APA sessions together with the wearing of a pedometer watch on disease activity of patients with JIA.

Being tested
Adaptated Physical Activity (APA) + pedometer watch
Medical subject headings
Arthritis, Juvenile

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adaptated Physical Activity (APA) + pedometer watchOther

    Adapted physical activities program : 12 weeks, 2 40-minutes sessions per week ( one broadcast live via online video conferencing and other one in autonomy according to a sequence of different personalized exercises defined by the APA's professional). Children are divided into 6 groups. Each session will be broken down into three parts: the warm-up (10mins), the session's corps alternating between five to eight of muscle strengthening, proprioception, and endurance exercises (20mins) and a cool-down with stretching (10mins). The physical activity performed during the sessions will be quantified with a heart rate monitor and the range of 60-70% of the maximum theoretical heart rate for each child will be respected.

    A pedometer watch will wear during 1 year and will provide the number of steps.

Study groups in NCT05572424
Study groupRoleWhat they receive
Adaptated Physical Activity + pedometer watchExperimentalFollow an Adapted Physical Activity program during 12 weeks and wear a pedometer watch during 1 year
Receives: Other: Adaptated Physical Activity (APA) + pedometer watch
Control groupNo interventionUsual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Juvenile Arthritis Disease Activity-27 Score Assesment

    JADAS-27 score includes 4 components :

    1. number of inflammatory joints among 27 joints identified,
    2. a medical assesment of clinical disease activity with Visual Analogic Scale (from 0 point = worst to 10 points = best),
    3. assesment of assesment of patient's well-being by the patient or a parent with Visual Analogic Scale (froom 0 point = worst to 10 points = best),
    4. sedimentation rate (from 0 to 10).

    Measured: Week 14

Secondary outcomes (13)

  1. Juvenile Arthritis Disease Activity-27 Score Assesment

    JADAS-27 score includes 4 components :

    1. number of inflammatory joints among 27 joints identified,
    2. a medical assesment of clinical disease activity with Visual Analogic Scale (from 0 point = worst to 10 points = best),
    3. assesment of assesment of patient's well-being by the patient or a parent with Visual Analogic Scale (froom 0 point = worst to 10 points = best),
    4. sedimentation rate (from 0 to 10).

    Measured: Weeks 26 and 50

  2. Evaluation of the physical activity level

    The difference of the medium physical activity level is assessed by the continue measures (for 7 days) of the time spent in the MVPA (Moderate to Vigorous Physical Activity) via actimetry (counts/min).

    Actimetric measurements will be performed before the start of the intervention to determine a value for V0, at 13 weeks (for V1), at 25 weeks (for V2), and at 49 weeks (for V3)

    Measured: Weeks 13, 25 and 49

  3. Evaluation of the physical activity level

    The difference of the medium physical activity level is assessed by the number of steps estimated by the pedometer watch (only for the experimental group).

    Pedometric measurements will be performed throughout the study but collected one week per month to determine a monthly value.

    Measured: Each day during 50 weeks

  4. Quantification of the difference in muscle strength

    By dynamometry (Newton)

    Measured: Weeks 14, 26 and 50

  5. Evolution of quality of life

    Difference of the score obtained in the Pediatric Quality of Life (PedsQL) tool. Score out of 100 for children assess and 100 for parents assess. A high score means a reduced quality of life.

    Measured: Weeks 14, 26 and 50

  6. Evolution of functional capacities

    Assessment by the questionnaire of the ChildHood Assessment Questionnaire (CHAQ-38) tool. Questionaire's score out of 3, it's a medium of 8 items. A high score means reduced functional capacities.

    Measured: Weeks 14, 26 and 50

  7. Evolution of pain

    Assessment by the Visual Analogic Scale (VAS) of the CHAQ-38 tool. VAS are out of 10. A high score means an increased pain.

    Measured: Weeks 14, 26 and 50

  8. Evolution of fatigue

    Difference of the score obtained in the PedsQL-Multidimensional Fatigue Scale questionnaire. Score out of 100 for children assess and 100 for parents assess. A high score means a increased fatigue.

    Measured: Weeks 14, 26 and 50

  9. Assessment of the feasibility of the program

    Assessment of program participation. Participation is the proportion of subjects who agree to participate in the study among eligible patients.

    Measured: week 2 to 13

  10. Assessment of the feasibility of the program

    Assessment of program completion. Completion is the proportion of subjects who complete the program and proportion of subjects who complete the exercise sessions.

    Measured: week 2 to 13

  11. Assessment of the feasibility of the program

    Assessment of program adherence. Adherence is the proportion of sessions attended by subjects.

    Measured: week 2 to 13

  12. Assessment of the feasibility of the program

    Assessment of program compliance. Compliance is the proportion of prescribed exercise during the session actually performed.

    Measured: week 2 to 13

  13. Assessment of the feasibility of the program

    Assessment of pedometer watch wearing time over the duration of the study.

    Measured: week 1 to 50

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2022
  2. Study start5 Jul 2023
  3. Primary completionSep 2024 (estimated)
  4. Study completionOct 2024 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05572424
Sponsor's protocol ID
2021/600
Acronym
ATHLETIQUE
Status last verified
Mar 2024
First submitted
25 Jul 2022
Last updated
18 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Py S, Maylie F, Parmentier AL, Vidal C, Cuinet B, Mauny F, Lohse A, Toussirot E, Yoshimasa S Jr, Tordi N, Binda D, Ballot-Schmit C. ATHLETIQUE: interest of an adapted physical activity program in patients with juvenile idiopathic arthritis: a feasibility and preliminary effectiveness study. Front Immunol. 2023 Jun 27;14:1213799. doi: 10.3389/fimmu.2023.1213799. eCollection 2023.

    PubMed 37441067

Questions about this trial

What is this clinical trial studying?

A study testing Adaptated Physical Activity (APA) + pedometer watch in people with Juvenile Idiopathic Arthritis, run by Centre Hospitalier Universitaire de Besancon at 3 sites 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 14 inclusion and 3 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 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 Claire BALLOT-SCHMIT, MD (0381219139, cballotschmit@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Juvenile Arthritis Disease Activity-27 Score Assesment (time frame: Week 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05572424, which also lists 1 linked publication.

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 18 Mar 2024.

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