A Phase 3 interventional study of aerobic training and Stretching exercises in Ankylosing Spondylitis, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-02-15.
Sponsored by Federal University of São Paulo · Phase 3, Interventional, and Treatment
This is a randomized controlled trial with blinded assessor on the effects of aerobic exercise (walking)in patients with Ankylosing Spondylitis.
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.
623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.
This study's enrollment of 70 is below the median of 92 across 349 interventional studies indexed under Spondylitis.
Browse Spondylitis studies →Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.
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Diagnosis of Ankylosing Spondylitis according to New York modified criteria.
Exclusion Criteria:
Uncontrolled Systemic Arterial Hypertension and Diabetes mellitus.
The patients in this arm perform a 50-minute-walking at anaerobic threshold plus stretching exercises 3 times a week for 12 weeks.
Other: aerobic training · Other: Stretching exercises
The control group perform global stretching exercises for approximately 20 minutes 3 times a week for 12 weeks.
Other: Stretching exercises
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.
Change in BASFI
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.
Time frame: Baseline, after 6, 12 and 24 weeks.
Change in BASDAI
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.
Time frame: Baseline, after 6, 12 and 24 weeks.
Change in BASMI
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.
Time frame: Baseline, after 6, 12 and 24 weeks.
Change in HAQ-S
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.
Time frame: Baseline, after 6, 12 and 24 weeks.
Incremental cardiopulmonary exercise testing protocol by treadmill
Incremental cardiopulmonary exercise testing protocol by treadmill is used to measure aerobic capacity of the patients.
Time frame: Baseline and after 12 weeks.
Levels of C reactive protein and erythrocyte rate sedimentation
CRP and ESR are laboratory methods to evaluate inflammatory response using blood sample.
Time frame: Baseline, after 6. 12 and 24 weeks
Levels of cytokines- TNF, IL10, IL6 and IL1.
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.
Time frame: Baseline and after 12 weeks.
Change in the Six minute walking test
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.
Time frame: Baseline, after 6, 12 and 24 weeks.
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Federal University of São Paulo