Interest of an Adapted Physical Activity (APA) Program Among Patients With Juvenile Idiopathic Arthritis: a Feasibility and Efficacy Preliminary Study
ATHLETIQUE
1 other identifier
interventional
40
1 country
3
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2023
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2022
CompletedFirst Posted
Study publicly available on registry
October 7, 2022
CompletedStudy Start
First participant enrolled
July 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedMarch 18, 2024
March 1, 2024
1.2 years
July 25, 2022
March 15, 2024
Conditions
Outcome Measures
Primary Outcomes (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).
Week 14
Secondary Outcomes (13)
Juvenile Arthritis Disease Activity-27 Score Assesment
Weeks 26 and 50
Evaluation of the physical activity level
Weeks 13, 25 and 49
Evaluation of the physical activity level
Each day during 50 weeks
Quantification of the difference in muscle strength
Weeks 14, 26 and 50
Evolution of quality of life
Weeks 14, 26 and 50
- +8 more secondary outcomes
Study Arms (2)
Adaptated Physical Activity + pedometer watch
EXPERIMENTALFollow an Adapted Physical Activity program during 12 weeks and wear a pedometer watch during 1 year
Control group
NO INTERVENTIONUsual care
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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 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
- Affiliation with a French social security system or beneficiary of such a system.
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
CHU de Besançon
Besançon, 25000, France
Hospices Civils de Lyon
Lyon, 69000, France
Hôpital Nord Franche-Comté
Trévenans, France
Related Publications (1)
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.
PMID: 37441067DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claire BALLOT-SCHMIT, MD
CHU de Besançon
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2022
First Posted
October 7, 2022
Study Start
July 5, 2023
Primary Completion
September 1, 2024
Study Completion
October 1, 2024
Last Updated
March 18, 2024
Record last verified: 2024-03