Interest of an Adapted Physical Activity (APA) Program Among Patients With Juvenile Idiopathic Arthritis: a Feasibility and Efficacy Preliminary Study
NCT ID: NCT05572424
Last Updated: 2024-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-07-05
2024-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Adaptated Physical Activity + pedometer watch
Follow an Adapted Physical Activity program during 12 weeks and wear a pedometer watch during 1 year
Adaptated Physical Activity (APA) + pedometer watch
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.
Control group
Usual care
No interventions assigned to this group
Interventions
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Adaptated Physical Activity (APA) + pedometer watch
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
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Inclusion Criteria
* 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
* 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
* Subject in the exclusion period of another study or is the "national volunteer register"
Exclusion Criteria
* 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
6 Years
17 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
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Principal Investigators
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Claire BALLOT-SCHMIT, MD
Role: PRINCIPAL_INVESTIGATOR
CHU de Besançon
Locations
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CHU de Besançon
Besançon, , France
Hospices Civils de Lyon
Lyon, , France
Hôpital Nord Franche-Comté
Trévenans, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2021/600
Identifier Type: -
Identifier Source: org_study_id
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