Exercise for SpondyloArthritis (SpA) - the ESpA Study The Effect of a Supervised Exercise Intervention on Disease Activity and Cardiovascular Risk in Patients With SpA - A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- Disease activity
研究概览
简要总结
The overall aim of this multicenter randomised controlled trial (RCT) is to investigate if exercise can modify the disease course and prevent comorbidity in patient with spondyloarthritis (SpA).
详细描述
International guidelines recommend exercise as a cornerstone in the management of SpA. Due to the typical features of SpA with reduced spinal mobility, the main focus for exercise has been flexibility exercise. Exercise trials for this patient group have mainly aimed at improving spinal mobility and there is limited evidence of the potential effects of exercise on disease pathogenesis and CVD risk factors.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of axial SpA (the Assessment of SpondyloArthritis International Society classification criteria) confirmed by a rheumatologist
- •Age, 18-70 -years
- •Steady medication for ≥3 months
- •Moderate disease activity defined as a BASDAI score of ≥3.5 or a patient global score ≥3.5
- •Not participated in a structured endurance and strength exercise program during the last 6 months (>1 hour/week)
排除标准
- •Severe co-morbidity which involves reduced exercise capacity and/or contraindications for physical activity as per American College of Sports Medicine guidelines for exercise testing
- •Not able to participate in weekly exercises sessions
研究组 & 干预措施
Exercise group
Exercise
干预措施: Exercise (Behavioral)
Control group
Participants in the control group will be asked to continue their usual physical activity habits
结局指标
主要结局
Disease activity
时间窗: 3 months
The Ankylosing Spondylitis Disease Activity Score (ASDAS) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
次要结局
- Blood samples(3 months (all analyses) 12 months (only CRP and ESR))
- Spinal mobility(3 months)
- Physical function(3 months and 12 months)
- Cardiorespiratory fitness(3 months)
- Body composition(3 months)
- Blood pressure(3 months)
- General health(3 months and 12 months)
- Health related quality of life(3 months and 12 months)
- Physical activity level(3 months and 12 months)
- Self-efficacy for physical activity(3 months and 12 months)
- Fatigue(3 months and 12 months)
- Sleep(3 months and 12 months)
- Arterial stiffness(3 months)
- Endothelial function(3 months)
研究者
Silje H Sveaas, PT, PhD
PhD
Diakonhjemmet Hospital