Interest of an Adapted Physical Activity (APA) Program Among Patients With Juvenile Idiopathic Arthritis: a Feasibility and Efficacy Preliminary Study
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Juvenile Arthritis Disease Activity-27 Score Assesment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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"
排除标准
- •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
研究组 & 干预措施
Control group
Usual care
Adaptated Physical Activity + pedometer watch
Follow an Adapted Physical Activity program during 12 weeks and wear a pedometer watch during 1 year
干预措施: Adaptated Physical Activity (APA) + pedometer watch (Other)
结局指标
主要结局
Juvenile Arthritis Disease Activity-27 Score Assesment
时间窗: Week 14
JADAS-27 score includes 4 components : 1. number of inflammatory joints among 27 joints identified, 2. a medical assesment of clinical disease activity with Visual Analogic Scale (from 0 point = worst to 10 points = best), 3. 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), 4. sedimentation rate (from 0 to 10).
次要结局
- Assessment of the feasibility of the program(week 1 to 50)
- Juvenile Arthritis Disease Activity-27 Score Assesment(Weeks 26 and 50)
- Quantification of the difference in muscle strength(Weeks 14, 26 and 50)
- Evaluation of the physical activity level(Each day during 50 weeks)
- Evolution of quality of life(Weeks 14, 26 and 50)
- Evolution of pain(Weeks 14, 26 and 50)
- Evolution of functional capacities(Weeks 14, 26 and 50)
- Evolution of fatigue(Weeks 14, 26 and 50)
- Evaluation of the physical activity level(Weeks 13, 25 and 49)
- Assessment of the feasibility of the program(week 2 to 13)