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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)

Primary Purpose

Juvenile Idiopathic Arthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Adaptated Physical Activity (APA) + pedometer watch
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Juvenile Idiopathic Arthritis

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Besançon
  • Hôpital Nord Franche-Comté

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Adaptated Physical Activity + pedometer watch

Control group

Arm Description

Follow an Adapted Physical Activity program during 12 weeks and wear a pedometer watch during 1 year

Usual care

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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)
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.
Quantification of the difference in muscle strength
By dynamometry (Newton)
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.
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.
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.
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.
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.
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.
Assessment of the feasibility of the program
Assessment of program adherence. Adherence is the proportion of sessions attended by subjects.
Assessment of the feasibility of the program
Assessment of program compliance. Compliance is the proportion of prescribed exercise during the session actually performed.
Assessment of the feasibility of the program
Assessment of pedometer watch wearing time over the duration of the study.

Full Information

First Posted
July 25, 2022
Last Updated
May 4, 2023
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT05572424
Brief Title
Interest of an Adapted Physical Activity (APA) Program Among Patients With Juvenile Idiopathic Arthritis: a Feasibility and Efficacy Preliminary Study
Acronym
ATHLETIQUE
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adaptated Physical Activity + pedometer watch
Arm Type
Experimental
Arm Description
Follow an Adapted Physical Activity program during 12 weeks and wear a pedometer watch during 1 year
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
Adaptated Physical Activity (APA) + pedometer watch
Intervention Description
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.
Primary Outcome Measure Information:
Title
Juvenile Arthritis Disease Activity-27 Score Assesment
Description
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).
Time Frame
Week 14
Secondary Outcome Measure Information:
Title
Juvenile Arthritis Disease Activity-27 Score Assesment
Description
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).
Time Frame
Weeks 26 and 50
Title
Evaluation of the physical activity level
Description
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)
Time Frame
Weeks 13, 25 and 49
Title
Evaluation of the physical activity level
Description
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.
Time Frame
Each day during 50 weeks
Title
Quantification of the difference in muscle strength
Description
By dynamometry (Newton)
Time Frame
Weeks 14, 26 and 50
Title
Evolution of quality of life
Description
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.
Time Frame
Weeks 14, 26 and 50
Title
Evolution of functional capacities
Description
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.
Time Frame
Weeks 14, 26 and 50
Title
Evolution of pain
Description
Assessment by the Visual Analogic Scale (VAS) of the CHAQ-38 tool. VAS are out of 10. A high score means an increased pain.
Time Frame
Weeks 14, 26 and 50
Title
Evolution of fatigue
Description
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.
Time Frame
Weeks 14, 26 and 50
Title
Assessment of the feasibility of the program
Description
Assessment of program participation. Participation is the proportion of subjects who agree to participate in the study among eligible patients.
Time Frame
week 2 to 13
Title
Assessment of the feasibility of the program
Description
Assessment of program completion. Completion is the proportion of subjects who complete the program and proportion of subjects who complete the exercise sessions.
Time Frame
week 2 to 13
Title
Assessment of the feasibility of the program
Description
Assessment of program adherence. Adherence is the proportion of sessions attended by subjects.
Time Frame
week 2 to 13
Title
Assessment of the feasibility of the program
Description
Assessment of program compliance. Compliance is the proportion of prescribed exercise during the session actually performed.
Time Frame
week 2 to 13
Title
Assessment of the feasibility of the program
Description
Assessment of pedometer watch wearing time over the duration of the study.
Time Frame
week 1 to 50

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claire BALLOT-SCHMIT, MD
Phone
0381219139
Email
cballotschmit@chu-besancon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphanie PY, PhD
Phone
0381218993
Email
s1py@chu-besancon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire BALLOT-SCHMIT, MD
Organizational Affiliation
CHU de Besançon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphanie Py, PhD
Email
s1py@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Claire Ballot-Schmit, MD
Facility Name
Hôpital Nord Franche-Comté
City
Trévenans
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Lohse, MD
Email
anne.lohse@hnfc.fr
First Name & Middle Initial & Last Name & Degree
Anne Lohse, MD

12. IPD Sharing Statement

Learn more about this trial

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

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