Effect of Exercise on Disease Activity and Cardiovascular Risk Factors in Patients With AS: A Single Blind Randomized Controlled Trail
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Disease activity
研究概览
简要总结
Background:
Exercise is recommended as a cornerstone in the treatment of ankylosing spondylitis together with medication. Last years, increased risk of cardiovascular diseases in patient with inflammatory diseases is reported, probably caused by inflammation and increased prevalence of traditional risk factors. In both healthy adults and other patient groups, cardiorespiratory and muscular strength exercises have been shown to have a positive effect on inflammation as well as on cardiovascular risk factors. To our knowledge this has not been shown in patients with ankylosing spondylitis.
Objective: The aim of this study is to investigate the effects of a cardiorespiratory and muscular strength exercise program on disease activity and cardiovascular risk factors in patients with ankylosing spondylitis
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 ankylosing spondylitis, confirmed by a rheumatologist
- •Age, 18-70 years
- •Not using TNF-α medication or steady medication for ≥3 months
- •Disease activity ≥2.1 on ankylosing spondylitis disease activity score defined as high disease activity
- •Not participated in a structured cardiorespiratory or muscle strengthening exercise program during the last year (>60 min once per week), including large amounts of brisk walking (>120 min per week)
排除标准
- •Known cardiovascular disease
- •Severe comorbidity which involves reduced exercise capacity
- •Not able to participate in weekly exercises sessions in Oslo
- •Pregnancy
结局指标
主要结局
Disease activity
时间窗: 12 weeks after baseline assessment
The Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) will be used to assess disease activity. It is a continuous measure based on patient-reported outcomes (back pain, duration of morning stiffness, patient global assessment and peripheral join complaints) and CRP, and higher values indicate higher disease activity. The minimal clinically important improvement for this instrument is reported to be ∆ ≥1.1, and ∆ ≥2.0 is considered a major improvement.
次要结局
- Body composition(12 weeks after baseline assessment)
- General health(12 weeks after baseline assessment)
- Blood samples(12 weeks after baseline assessment)
- Blood pressure(12 weeks after baseline assessment)
- Physical function(12 weeks after baseline assessment)
- Electrocardiography(12 weeks after baseline assessment)
- Physical fitness(12 weeks after baseline assessment)
- Physical activity level(12 weeks after baseline assessment and 12 months after the intervention)
研究者
Silje H Sveaas, PT, PhD
PhD.student
Diakonhjemmet Hospital