Effects of Aerobic Training in Patients With Ankylosing Spondylitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in BASFI
研究概览
简要总结
This is a randomized controlled trial with blinded assessor on the effects of aerobic exercise (walking)in patients with Ankylosing Spondylitis.
详细描述
Ankylosing Spondylitis (AS) is a systemic inflammatory disease that affects mainly the spine and compromises globally the physical capacity of the patients. Despite new advances in pharmacological therapy, physiotherapy and exercise remain essential in the treatment of AS. However, the literature lacks studies showing which types of exercises are more effective in patients with AS.
This is a randomized controlled trial with the objective is to evaluate the effects of aerobic training on functional capacity, mobility, disease activity, cardiopulmonary capacity and cytokine levels (TNF, IL10, IL6 and IL1) in patients with AS.
The duration of the trial is 24 weeks with the first 12 weeks reserved to exercise programs. The participants will be divided in two groups. The intervention group (IG) will perform walking for 50 minutes plus global stretching 3 times a week for 12 weeks. The control group (CG) will do only stretching exercises 3 times a week for 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
- Single (Outcomes Assessor)
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
- •Diagnosis of Ankylosing Spondylitis according to New York modified criteria.
- •Stable drug treatment for at least 3 months
- •Sedentary for at least 3 months before randomization
- •Steinbrocker class I/II
排除标准
- •Uncontrolled Systemic Arterial Hypertension and Diabetes mellitus.
- •Ischemic heart disease
- •Clinically significant diseases
- •Orthopedic surgery, such as hip arthroplasty, in the last year.
- •Inability to walk.
研究组 & 干预措施
Aerobic training
The patients in this arm perform a 50-minute-walking at anaerobic threshold plus stretching exercises 3 times a week for 12 weeks.
干预措施: aerobic training (Other)
Aerobic training
The patients in this arm perform a 50-minute-walking at anaerobic threshold plus stretching exercises 3 times a week for 12 weeks.
干预措施: Stretching exercises (Other)
Stretching exercises
The control group perform global stretching exercises for approximately 20 minutes 3 times a week for 12 weeks.
干预措施: Stretching exercises (Other)
结局指标
主要结局
Change in BASFI
时间窗: Baseline, after 6, 12 and 24 weeks.
Bath Ankylosing Spondylitis Functional Index (BASFI) is a quaestionnaire with 10 questions about functional capacity validated to AS patients. Each question is answered with a visual analogue scale 0-10 cm. Zero means the best, and 10 the worst function.
次要结局
- Change in BASDAI(Baseline, after 6, 12 and 24 weeks.)
- Change in BASMI(Baseline, after 6, 12 and 24 weeks.)
- Change in HAQ-S(Baseline, after 6, 12 and 24 weeks.)
- Incremental cardiopulmonary exercise testing protocol by treadmill(Baseline and after 12 weeks.)
- Levels of C reactive protein and erythrocyte rate sedimentation(Baseline, after 6. 12 and 24 weeks)
- Levels of cytokines- TNF, IL10, IL6 and IL1.(Baseline and after 12 weeks.)
- Change in the Six minute walking test(Baseline, after 6, 12 and 24 weeks.)
研究者
Martin F Simoes, MD
MD
Federal University of São Paulo