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Completed

NCT Number: NCT01436942

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

Background:

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

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Key information

Conditions

Ankylosing Spondyliti

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diakonhjemmet Hospital

Oslo, Norway

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Exercise

Behavioral

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.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Diakonhjemmet Hospital

Other

Collaborators

  • University of Oslo

Registry information

Official study title

Effect of Exercise on Disease Activity and Cardiovascular Risk Factors in Patients With AS: A Single Blind Randomized Controlled Trail

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 20, 2011
Registry last updated
Feb 3, 2015

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.