Effects of Aerobic Training in Patients With Ankylosing Spondylitis
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Sao Paulo、ブラジル、04039-002
- Universidade Federal de Sao Paulo
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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プラセボコンパレーター：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in BASFI
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in BASDAI
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
時間枠：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
時間枠：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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協力者と研究者
捜査官
- スタディディレクター：Jamil Natour, Prof, MD、Federal University of São Paulo
出版物と役立つリンク
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研究開始
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研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
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最終確認日
詳しくは
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