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Effects of Aerobic Training in Patients With Ankylosing Spondylitis

This study is currently recruiting participants.
Verified November 2012 by Federal University of São Paulo
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: November 6, 2012
Last verified: November 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 84
Study Start Date: July 2011
Estimated Study Completion Date: November 2012
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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01586650

Contacts
Contact: Martin F Simoes, MD 55 11 55764239 fabiojennings@uol.com.br
Contact: Jamil Natour, Prof, MD 55 11 55764239 jnatour@unifesp.br

Locations
Brazil
Universidade Federal de Sao Paulo Recruiting
Sao Paulo, Brazil, 04039-002
Contact: Martin F Jennings Simoes, MD     55 11 5576 4239     fabiojennings@uol.com.br    
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
Study First Received: April 21, 2012
Last Updated: November 6, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by 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

ClinicalTrials.gov processed this record on May 22, 2013