- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01586650
Effects of Aerobic Training in Patients With Ankylosing Spondylitis
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Sao Paulo, 브라질, 04039-002
- Universidade Federal de Sao Paulo
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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위약 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in BASFI
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in BASDAI
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 연구 책임자: Jamil Natour, Prof, MD, Federal University of São Paulo
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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