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

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.

Study Overview

• Status: Recruiting
• Conditions: Juvenile Idiopathic Arthritis
• Intervention / Treatment: Other: Adaptated Physical Activity (APA) + pedometer watch

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claire BALLOT-SCHMIT, MD; Phone Number: 0381219139; Email: cballotschmit@chu-besancon.fr
• Study Contact Backup: Name: Stéphanie PY, PhD; Phone Number: 0381218993; Email: s1py@chu-besancon.fr

Study Locations

• France
  • Besançon, France, 25000
    • Recruiting
    • CHU de Besançon
    • Contact: Stéphanie Py, PhD; Email: s1py@chu-besancon.fr
    • Principal Investigator: Claire Ballot-Schmit, MD
  • Lyon, France, 69000
    • Recruiting
    • Hospices Civils de Lyon
    • Contact: Samira Plassart, PhD; Email: samira.plassart@chu-lyon.fr
    • Principal Investigator: Audrey Laurent, MD
  • Trévenans, France
    • Recruiting
    • Hôpital Nord Franche-Comté
    • Contact: Anne LOHSE, MD; Email: anne.lohse@hnfc.fr
    • Principal Investigator: Anne LOHSE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Usual care
Experimental: Adaptated Physical Activity + pedometer watch; Follow an Adapted Physical Activity program during 12 weeks and wear a pedometer watch during 1 year	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Juvenile Arthritis Disease Activity-27 Score Assesment	JADAS-27 score includes 4 components : number of inflammatory joints among 27 joints identified,; a medical assesment of clinical disease activity with Visual Analogic Scale (from 0 point = worst to 10 points = best),; 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),; sedimentation rate (from 0 to 10).	Week 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Juvenile Arthritis Disease Activity-27 Score Assesment	JADAS-27 score includes 4 components : number of inflammatory joints among 27 joints identified,; a medical assesment of clinical disease activity with Visual Analogic Scale (from 0 point = worst to 10 points = best),; 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),; sedimentation rate (from 0 to 10).	Weeks 26 and 50
Evaluation of the physical activity level	The difference of the medium physical activity level is assessed by the continue measures (for 7 days) of the time spent in the MVPA (Moderate to Vigorous Physical Activity) via actimetry (counts/min). Actimetric measurements will be performed before the start of the intervention to determine a value for V0, at 13 weeks (for V1), at 25 weeks (for V2), and at 49 weeks (for V3)	Weeks 13, 25 and 49
Evaluation of the physical activity level	The difference of the medium physical activity level is assessed by the number of steps estimated by the pedometer watch (only for the experimental group). Pedometric measurements will be performed throughout the study but collected one week per month to determine a monthly value.	Each day during 50 weeks
Quantification of the difference in muscle strength	By dynamometry (Newton)	Weeks 14, 26 and 50
Evolution of quality of life	Difference of the score obtained in the Pediatric Quality of Life (PedsQL) tool. Score out of 100 for children assess and 100 for parents assess. A high score means a reduced quality of life.	Weeks 14, 26 and 50
Evolution of functional capacities	Assessment by the questionnaire of the ChildHood Assessment Questionnaire (CHAQ-38) tool. Questionaire's score out of 3, it's a medium of 8 items. A high score means reduced functional capacities.	Weeks 14, 26 and 50
Evolution of pain	Assessment by the Visual Analogic Scale (VAS) of the CHAQ-38 tool. VAS are out of 10. A high score means an increased pain.	Weeks 14, 26 and 50
Evolution of fatigue	Difference of the score obtained in the PedsQL-Multidimensional Fatigue Scale questionnaire. Score out of 100 for children assess and 100 for parents assess. A high score means a increased fatigue.	Weeks 14, 26 and 50
Assessment of the feasibility of the program	Assessment of program participation. Participation is the proportion of subjects who agree to participate in the study among eligible patients.	week 2 to 13
Assessment of the feasibility of the program	Assessment of program completion. Completion is the proportion of subjects who complete the program and proportion of subjects who complete the exercise sessions.	week 2 to 13
Assessment of the feasibility of the program	Assessment of program adherence. Adherence is the proportion of sessions attended by subjects.	week 2 to 13
Assessment of the feasibility of the program	Assessment of program compliance. Compliance is the proportion of prescribed exercise during the session actually performed.	week 2 to 13
Assessment of the feasibility of the program	Assessment of pedometer watch wearing time over the duration of the study.	week 1 to 50

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Claire BALLOT-SCHMIT, MD, CHU de Besançon

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Juvenile
• Other Study ID Numbers: 2021/600

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No