Effects of Aerobic Training in Patients With Ankylosing Spondylitis
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Sao Paulo、巴西、04039-002
- Universidade Federal de Sao Paulo
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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
Exclusion Criteria:
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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The intervention comprises fifty minutes of walking at anaerobic threshold plus stretching exercises 3 times a week for 12 weeks.
Global stretching exercises will be performed for about 20 minutes 3 times a week for 12 weeks with supervision of specialized physiotherapists.
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安慰剂比较：Stretching exercises
The control group perform global stretching exercises for approximately 20 minutes 3 times a week for 12 weeks.
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Global stretching exercises will be performed for about 20 minutes 3 times a week for 12 weeks with supervision of specialized physiotherapists.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in BASFI
大体时间：Baseline, after 6, 12 and 24 weeks.
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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.
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Baseline, after 6, 12 and 24 weeks.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in BASDAI
大体时间：Baseline, after 6, 12 and 24 weeks.
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Bath Ankylosing Spondylitis Disease Activity Score (BASDAI) is a instrument with 6 questions about disease activity validated to AS patients.
The questions comprise the following areas: back pain, peripheral pain, morning stifness, fatigue and enthesitis.
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Baseline, after 6, 12 and 24 weeks.
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Change in BASMI
大体时间：Baseline, after 6, 12 and 24 weeks.
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Bath Ankylosing Spondylitis Mobility Index (BASMI) is an instrument that comprises 5 measures of mobility validated to AS patients.
The measurements are: cervical rotation, lumbar flexion (Schober's test modified, intermalleolar distance, lumbar side flexion and tragus to wall.
The total score is shown in a 0-10 cm visual analogue scale.
The low scores represent better mobility.
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Baseline, after 6, 12 and 24 weeks.
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Change in HAQ-S
大体时间：Baseline, after 6, 12 and 24 weeks.
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Health Assessment Questionnaire for Spondyloarthritis (HAQ-S)is a questionnaire with 10 domains about functional capacity validated to AS patients.
The scores ranges from 0 to 3.
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Baseline, after 6, 12 and 24 weeks.
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Incremental cardiopulmonary exercise testing protocol by treadmill
大体时间：Baseline and after 12 weeks.
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Incremental cardiopulmonary exercise testing protocol by treadmill is used to measure aerobic capacity of the patients.
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Baseline and after 12 weeks.
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Levels of C reactive protein and erythrocyte rate sedimentation
大体时间：Baseline, after 6. 12 and 24 weeks
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CRP and ESR are laboratory methods to evaluate inflammatory response using blood sample.
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Baseline, after 6. 12 and 24 weeks
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Levels of cytokines- TNF, IL10, IL6 and IL1.
大体时间：Baseline and after 12 weeks.
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Cytokines are substances that make part of inflammatory response.
The most important cytokines- TNF alpha, IL10, IL6 and IL1 will be measured in serum samples.
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Baseline and after 12 weeks.
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Change in the Six minute walking test
大体时间：Baseline, after 6, 12 and 24 weeks.
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The 6-minute walking test is a instrument to evaluate functional capacity.
It is performed measuring the distance that the participant is able to walk during 6 minutes.
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Baseline, after 6, 12 and 24 weeks.
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合作者和调查者
调查人员
- 研究主任：Jamil Natour, Prof, MD、Federal University of São Paulo
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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