Effects of Aerobic Training in Patients With Ankylosing Spondylitis

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Martin F Simoes, MD, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01586650
First received: April 21, 2012
Last updated: March 31, 2014
Last verified: March 2014

April 21, 2012
March 31, 2014
July 2011
November 2012   (final data collection date for primary outcome measure)
Change in BASFI [ Time Frame: Baseline, after 6, 12 and 24 weeks. ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01586650 on ClinicalTrials.gov Archive Site
  • Change in BASDAI [ Time Frame: Baseline, after 6, 12 and 24 weeks. ] [ Designated as safety issue: No ]
    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.
  • Change in BASMI [ Time Frame: Baseline, after 6, 12 and 24 weeks. ] [ Designated as safety issue: No ]
    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.
  • Change in HAQ-S [ Time Frame: Baseline, after 6, 12 and 24 weeks. ] [ Designated as safety issue: No ]
    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.
  • Incremental cardiopulmonary exercise testing protocol by treadmill [ Time Frame: Baseline and after 12 weeks. ] [ Designated as safety issue: No ]
    Incremental cardiopulmonary exercise testing protocol by treadmill is used to measure aerobic capacity of the patients.
  • Levels of C reactive protein and erythrocyte rate sedimentation [ Time Frame: Baseline, after 6. 12 and 24 weeks ] [ Designated as safety issue: No ]
    CRP and ESR are laboratory methods to evaluate inflammatory response using blood sample.
  • Levels of cytokines- TNF, IL10, IL6 and IL1. [ Time Frame: Baseline and after 12 weeks. ] [ Designated as safety issue: No ]
    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.
  • Change in the Six minute walking test [ Time Frame: Baseline, after 6, 12 and 24 weeks. ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Effects of Aerobic Training in Patients With Ankylosing Spondylitis
Not Provided

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Ankylosing Spondylitis
  • Other: aerobic training
    The intervention comprises fifty minutes of walking at anaerobic threshold plus stretching exercises 3 times a week for 12 weeks.
  • Other: Stretching exercises
    Global stretching exercises will be performed for about 20 minutes 3 times a week for 12 weeks with supervision of specialized physiotherapists.
  • Experimental: 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.
    Interventions:
    • Other: aerobic training
    • Other: Stretching exercises
  • Placebo Comparator: Stretching exercises
    The control group perform global stretching exercises for approximately 20 minutes 3 times a week for 12 weeks.
    Intervention: Other: Stretching exercises
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
February 2013
November 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01586650
1325/08
Yes
Martin F Simoes, MD, Federal University of São Paulo
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Study Director: Jamil Natour, Prof, MD Federal University of São Paulo
Federal University of São Paulo
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP