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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-05

Study Completion Date

2024-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Juvenile Idiopathic Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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

Group Type EXPERIMENTAL

Adaptated Physical Activity (APA) + pedometer watch

Intervention Type OTHER

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

Group Type NO_INTERVENTION

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.

Intervention Type OTHER

Eligibility Criteria

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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.


* 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
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Hospices Civils de Lyon

Lyon, , France

Site Status RECRUITING

Hôpital Nord Franche-Comté

Trévenans, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Claire BALLOT-SCHMIT, MD

Role: CONTACT

0381219139

Stéphanie PY, PhD

Role: CONTACT

0381218993

Facility Contacts

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Stéphanie Py, PhD

Role: primary

Samira Plassart, PhD

Role: primary

Anne Lohse, MD

Role: primary

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.

Reference Type DERIVED
PMID: 37441067 (View on PubMed)

Other Identifiers

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2021/600

Identifier Type: -

Identifier Source: org_study_id

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