Effects of Aerobic Training in Patients With Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01586650
• Other study ID #: 1325/08
• Status: Completed
• Phase: Phase 3
• First received: April 21, 2012
• Last updated: February 14, 2017
• Start date: July 2011
• Est. completion date: February 2013

Study information

• Verified date: February 2017
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized controlled trial with blinded assessor on the effects of aerobic exercise (walking)in patients with Ankylosing Spondylitis.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Other:
• aerobic training
The intervention comprises fifty minutes of walking at anaerobic threshold plus stretching exercises 3 times a week for 12 weeks.
• Stretching exercises
Global stretching exercises will be performed for about 20 minutes 3 times a week for 12 weeks with supervision of specialized physiotherapists.

Locations

Country	Name	City	State
Brazil	Universidade Federal de Sao Paulo	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Braun J, van den Berg R, Baraliakos X, Boehm H, Burgos-Vargas R, Collantes-Estevez E, Dagfinrud H, Dijkmans B, Dougados M, Emery P, Geher P, Hammoudeh M, Inman RD, Jongkees M, Khan MA, Kiltz U, Kvien T, Leirisalo-Repo M, Maksymowych WP, Olivieri I, Pavelka K, Sieper J, Stanislawska-Biernat E, Wendling D, Ozgocmen S, van Drogen C, van Royen B, van der Heijde D. 2010 update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis. 2011 Jun;70(6):896-904. doi: 10.1136/ard.2011.151027. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, after 6, 12 and 24 weeks.
Secondary	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.	Baseline, after 6, 12 and 24 weeks.
Secondary	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.	Baseline, after 6, 12 and 24 weeks.
Secondary	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.	Baseline, after 6, 12 and 24 weeks.
Secondary	Incremental cardiopulmonary exercise testing protocol by treadmill	Incremental cardiopulmonary exercise testing protocol by treadmill is used to measure aerobic capacity of the patients.	Baseline and after 12 weeks.
Secondary	Levels of C reactive protein and erythrocyte rate sedimentation	CRP and ESR are laboratory methods to evaluate inflammatory response using blood sample.	Baseline, after 6. 12 and 24 weeks
Secondary	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.	Baseline and after 12 weeks.
Secondary	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.	Baseline, after 6, 12 and 24 weeks.