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

C

Centre Hospitalier Universitaire de Besancon

Status

Enrolling

Conditions

Juvenile Idiopathic Arthritis

Treatments

Other: Adaptated Physical Activity (APA) + pedometer watch

Study type

Interventional

Funder types

Other

Identifiers

NCT05572424
2021/600

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Adaptated Physical Activity + pedometer watch
Experimental group
Description:
Follow an Adapted Physical Activity program during 12 weeks and wear a pedometer watch during 1 year
Treatment:
Other: Adaptated Physical Activity (APA) + pedometer watch
Control group
No Intervention group
Description:
Usual care

Trial contacts and locations

3

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Central trial contact

Stéphanie PY, PhD; Claire BALLOT-SCHMIT, MD

Data sourced from clinicaltrials.gov

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