Skip to main content
OpenTrials
Completed

NCT Number: NCT01586650

Effects of Aerobic Training in Patients With Ankylosing Spondylitis

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universidade Federal de Sao Paulo

São Paulo, 04039-002, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aerobic training

Other

The intervention comprises fifty minutes of walking at anaerobic threshold plus stretching exercises 3 times a week for 12 weeks.

Stretching exercises

Other

Global stretching exercises will be performed for about 20 minutes 3 times a week for 12 weeks with supervision of specialized physiotherapists.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Apr 27, 2012
Registry last updated
Feb 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.