NCT02502539Unknown不适用
Cellular and Molecular Adaptations to Exercise-induced Inflammatory Response in Children With Autoimmune Diseases
University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Percent change
研究概览
简要总结
Juvenile idiopathic arthritis (JIA) is a chronic disease characterized by persistent joint inflammation. The immune system disruption that leads to overproduction of pro-inflammatory cytokines (TNF-α, IL-1, IL-6) is a cascade of events on different levels-some molecular, some cellular, and some systemic. Our objective is to identify the mechanisms through which physical activity is liable to mediate inflammatory balance in autoimmune disease settings, and specifically in JIA patients.
详细描述
Feasibility study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between 8 and 12 years
- •Tanner stage < T2
- •polyarthritis, oligoarthritis and ERA sub-type of JIA
- •Stable disease during 3 months before starting study
排除标准
- •Infection
- •Anti-IL6 treatment
- •More than 6h per week of physical activity
- •Systemic corticosteroid treatment during the 3 months before starting study
- •Systemic JIA
- •JIA not mastered by treatments
- •Other autoimmunity or auto-inflammatory diseases
- •Participation in another clinical research protocol
结局指标
主要结局
Percent change
时间窗: AT DAY 1
Percent change, before and after a controlled session of physical activity session, of serum and secretion kinetics of IL-6 and its soluble receptors (sIL- 6R and sgp130)
次要结局
- pain (VAS)(at day 1)
- locomotors function (CHAQ)(at day 1)
- swelling of knee(at day 1)
- rate of miRNA(at day 1)
- plasma level of melatonin(at day 1)
- sitfness of knee(at day 1)
研究者
研究点 (2)
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