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

Study Overview
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Brief Summary
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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

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

Conditions
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Ankylosing Spondyliti

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise group<br> | Behavioral: Exercise<br>* 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.<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease activity | 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. | 12 weeks after baseline assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrocardiography | To measure the electrical activity of the heart. | 12 weeks after baseline assessment | 
| Blood samples | 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) | 12 weeks after baseline assessment | 
| Blood pressure |  | 12 weeks after baseline assessment | 
| Physical fitness | 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). | 12 weeks after baseline assessment | 
| Body composition | Weight, height, waist circumference will be measured. Dual Energy X-ray Absortiometry (DEXA) will be used to assess body composition. | 12 weeks after baseline assessment | 
| Physical function | Will be assessed with the patient reported index Bath Ankylosing Spondylitis Functional Index (BASFI). | 12 weeks after baseline assessment | 
| General health | Will be assessed with the generic General Health Questionnaire (GHQ-12). | 12 weeks after baseline assessment | 
| Physical activity level | Will be assessed with the International Physical Activity Questionnaire short version (IPAQ-s). | 12 weeks after baseline assessment and 12 months after the intervention |