Assessment of the Efficacy of a Physical Training Program in Patients With Ankylosing Spondylitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Percentage of patients reaching an ASAS 20 response
研究概览
简要总结
Purpose: to assess the efficacy of a physical training program in patients with ankylosing spondylitis (AS) in a randomized controlled study
详细描述
AS is a chronic inflammatory rheumatic disorder affecting spine, peripheral joints and entheses. Patients undergo pain, stiffness and reduced mobility of spine and joints. Patients experience limitations in physical activities and reduced quality of life. Some uncontrolled studies reported benefits of physical activity in patients with AS.
The aim of the present study is to assess the efficacy of a physical training program in patients with AS.
Patients will be randomized in two parallel arms: program of personalized physical training (intervention group [PEPc]) or program of information about physical activity (control group [PIAP]).
Patients will be evaluated at 12 and 24 weeks on activity, functional and metrological scores (ASAS 20, ASAS 5/6, ASDAS, BASDAI, BASFI, BASMI); biological inflammation (CRP); NSAID use and pain VAS.
Primary outcome: percentage of patients reaching an ASAS 20 response at 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with AS according to ASAS criteria,
- •treated or not with NSAID,
- •synthetic DMARD or anti-TNF agent.
排除标准
- •Contraindications to physical training program (e.g. cardiac failure, pregnancy, painful arthroplasty or lower limbs damaged joint).
结局指标
主要结局
Percentage of patients reaching an ASAS 20 response
时间窗: Week 12
次要结局
- Percentage of patients reaching an ASAS 20 response(Week 24)