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Effect of Exercise on Disease Activity and Cardiovascular Risk Factors in Patients With Ankylosing Spondylitis

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. Identifier: NCT01436942
Recruitment Status : Completed
First Posted : September 20, 2011
Last Update Posted : February 3, 2015
University of Oslo
Information provided by (Responsible Party):
Silje H Sveaas, PT, PhD, Diakonhjemmet Hospital

Brief Summary:


Exercise is recommended as a cornerstone in the treatment of ankylosing spondylitis together with medication. Last years, increased risk of cardiovascular diseases in patient with inflammatory diseases is reported, probably caused by inflammation and increased prevalence of traditional risk factors. In both healthy adults and other patient groups, cardiorespiratory and muscular strength exercises have been shown to have a positive effect on inflammation as well as on cardiovascular risk factors. To our knowledge this has not been shown in patients with ankylosing spondylitis.

Objective: The aim of this study is to investigate the effects of a cardiorespiratory and muscular strength exercise program on disease activity and cardiovascular risk factors in patients with ankylosing spondylitis

Condition or disease Intervention/treatment Phase
Ankylosing Spondyliti Behavioral: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Exercise on Disease Activity and Cardiovascular Risk Factors in Patients With AS: A Single Blind Randomized Controlled Trail
Study Start Date : September 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Exercise group Behavioral: Exercise

The exercise intervention will be carried out at a fitness center with supervision from a physiotherapist.

A cardiorespiratory and muscle strengthening exercise program following the American College of Sports Medicine (ACSM) recommendations for maintenance and improvement of physical fitness. Cardiorespiratory fitness: two interval sessions (4 x 4 min), one continuous moderate exercise session (40 min) on a treadmill. The muscle strength exercises will consist of: 15-20 repetitions, large muscle groups as thighs, back and abdomen.

Dose: 12 weeks. Three times a week, 60 minutes.

No Intervention: Control group

Primary Outcome Measures :
  1. Disease activity [ Time Frame: 12 weeks after baseline assessment ]
    The Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) will be used to assess disease activity. It is a continuous measure based on patient-reported outcomes (back pain, duration of morning stiffness, patient global assessment and peripheral join complaints) and CRP, and higher values indicate higher disease activity. The minimal clinically important improvement for this instrument is reported to be ∆ ≥1.1, and ∆ ≥2.0 is considered a major improvement.

Secondary Outcome Measures :
  1. Electrocardiography [ Time Frame: 12 weeks after baseline assessment ]
    To measure the electrical activity of the heart.

  2. Blood samples [ Time Frame: 12 weeks after baseline assessment ]
    Analyzed for both general and endothelial specific markers of inflammation and cardiovascular risk(total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, glucose, NTproBNP, TNF-α, IL-6, IL-18, high sensitive C-reactive protein and sedimentation rate)

  3. Blood pressure [ Time Frame: 12 weeks after baseline assessment ]
  4. Physical fitness [ Time Frame: 12 weeks after baseline assessment ]
    Cardiorespiratory fitness will be assessed with an indirect maximal walking test on a treadmill for estimation of peak oxygen uptake according to modified Balke protocol. Hand grip strength will be assessed with GRIPPIT. Spinal and hip mobility will be assessed with the Bath Ankylosing Spondylitis Metrology index (BASMI), and chest expansion will be measured as the difference between maximal inspiration and expiration at the level of xipoideus (cm).

  5. Body composition [ Time Frame: 12 weeks after baseline assessment ]
    Weight, height, waist circumference will be measured. Dual Energy X-ray Absortiometry (DEXA) will be used to assess body composition.

  6. Physical function [ Time Frame: 12 weeks after baseline assessment ]
    Will be assessed with the patient reported index Bath Ankylosing Spondylitis Functional Index (BASFI).

  7. General health [ Time Frame: 12 weeks after baseline assessment ]
    Will be assessed with the generic General Health Questionnaire (GHQ-12).

  8. Physical activity level [ Time Frame: 12 weeks after baseline assessment and 12 months after the intervention ]
    Will be assessed with the International Physical Activity Questionnaire short version (IPAQ-s).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of ankylosing spondylitis, confirmed by a rheumatologist
  • Age, 18-70 years
  • Not using TNF-α medication or steady medication for ≥3 months
  • Disease activity ≥2.1 on ankylosing spondylitis disease activity score defined as high disease activity
  • Not participated in a structured cardiorespiratory or muscle strengthening exercise program during the last year (>60 min once per week), including large amounts of brisk walking (>120 min per week)

Exclusion Criteria:

  • Known cardiovascular disease
  • Severe comorbidity which involves reduced exercise capacity
  • Not able to participate in weekly exercises sessions in Oslo
  • Pregnancy

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 identifier (NCT number): NCT01436942

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Diakonhjemmet Hospital
Oslo, Norway
Sponsors and Collaborators
Diakonhjemmet Hospital
University of Oslo
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Silje H Sveaas, PT, PhD, PhD.student, Diakonhjemmet Hospital Identifier: NCT01436942    
Other Study ID Numbers: Diakonhjemmet Hospital
First Posted: September 20, 2011    Key Record Dates
Last Update Posted: February 3, 2015
Last Verified: March 2013