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Effects of Aerobic Training in Patients With Ankylosing Spondylitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01586650
First Posted: April 27, 2012
Last Update Posted: February 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  Purpose
This is a randomized controlled trial with blinded assessor on the effects of aerobic exercise (walking)in patients with Ankylosing Spondylitis.

Condition Intervention Phase
Ankylosing Spondylitis Other: aerobic training Other: Stretching exercises Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Martin F Simoes, MD, Federal University of São Paulo:

Primary Outcome Measures:
  • Change in BASFI [ Time Frame: Baseline, after 6, 12 and 24 weeks. ]
    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.


Secondary Outcome Measures:
  • Change in BASDAI [ Time Frame: Baseline, after 6, 12 and 24 weeks. ]
    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. ]
    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. ]
    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. ]
    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 ]
    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. ]
    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. ]
    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.


Enrollment: 70
Study Start Date: July 2011
Study Completion Date: February 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Placebo Comparator: Stretching exercises
The control group perform global stretching exercises for approximately 20 minutes 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.

Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01586650


Locations
Brazil
Universidade Federal de Sao Paulo
Sao Paulo, Brazil, 04039-002
Sponsors and Collaborators
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Study Director: Jamil Natour, Prof, MD Federal University of São Paulo
  More Information

Publications:
Responsible Party: Martin F Simoes, MD, MD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01586650     History of Changes
Other Study ID Numbers: 1325/08
First Submitted: April 21, 2012
First Posted: April 27, 2012
Last Update Posted: February 15, 2017
Last Verified: February 2017

Keywords provided by Martin F Simoes, MD, Federal University of São Paulo:
ankylosing spondylitis
aerobic exercise

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis