Clinical trial NCT05572424: Interest of an Adapted Physical Activity (APA) Program Among Patients With Juvenile Idiopathic Arthritis: a Feasibility and Efficacy Preliminary Study
Official title: Interest of an Adapted Physical Activity (APA) Program Among Patients With Juvenile Idiopathic Arthritis: a Feasibility and Efficacy Preliminary Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Juvenile Idiopathic Arthritis
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion criteria:

* 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
* 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"

Exclusion criteria :

* 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

Primary outcomes:
measure: Juvenile Arthritis Disease Activity-27 Score Assesment
timeFrame: Week 14
Secondary outcomes:
measure: Juvenile Arthritis Disease Activity-27 Score Assesment
timeFrame: Weeks 26 and 50
measure: Evaluation of the physical activity level
timeFrame: Weeks 13, 25 and 49
measure: Evaluation of the physical activity level
timeFrame: Each day during 50 weeks
measure: Quantification of the difference in muscle strength
timeFrame: Weeks 14, 26 and 50
measure: Evolution of quality of life
timeFrame: Weeks 14, 26 and 50
measure: Evolution of functional capacities
timeFrame: Weeks 14, 26 and 50
measure: Evolution of pain
timeFrame: Weeks 14, 26 and 50
measure: Evolution of fatigue
timeFrame: Weeks 14, 26 and 50
measure: Assessment of the feasibility of the program
timeFrame: week 2 to 13
measure: Assessment of the feasibility of the program
timeFrame: week 2 to 13
measure: Assessment of the feasibility of the program
timeFrame: week 2 to 13
measure: Assessment of the feasibility of the program
timeFrame: week 2 to 13
measure: Assessment of the feasibility of the program
timeFrame: week 1 to 50
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Trévenans
country: France
facility: Hôpital Nord Franche-Comté
Study officials:
affiliation: CHU de Besançon
name: Claire BALLOT-SCHMIT, MD
role: PRINCIPAL_INVESTIGATOR
References: