The Effect of Exercise on Disease Activity and Cardiovascular Risk for Patients With Axial SpondyloArthritis

Study Overview
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Brief Summary
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The overall aim of this multicenter randomised controlled trial (RCT) is to investigate if exercise can modify the disease course and prevent comorbidity in patient with spondyloarthritis (SpA).

Detailed Description
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International guidelines recommend exercise as a cornerstone in the management of SpA. Due to the typical features of SpA with reduced spinal mobility, the main focus for exercise has been flexibility exercise. Exercise trials for this patient group have mainly aimed at improving spinal mobility and there is limited evidence of the potential effects of exercise on disease pathogenesis and CVD risk factors.

Official Title
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Exercise for SpondyloArthritis (SpA) - the ESpA Study The Effect of a Supervised Exercise Intervention on Disease Activity and Cardiovascular Risk in Patients With SpA - A Multicenter Randomized Controlled Trial

Conditions
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Axial Spondyloarthritis

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of axial SpA (the Assessment of SpondyloArthritis International Society classification criteria) confirmed by a rheumatologist Age, 18-70 -years Steady medication for ≥3 months Moderate disease activity defined as a BASDAI score of ≥3.5 or a patient global score ≥3.5 Not participated in a structured endurance and strength exercise program during the last 6 months (>1 hour/week) Exclusion Criteria: Severe co-morbidity which involves reduced exercise capacity and/or contraindications for physical activity as per American College of Sports Medicine guidelines for exercise testing Not able to participate in weekly exercises sessions 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>Exercise | Behavioral: Exercise<br>* An exercise program for 40-60 minutes three times a week in 3 months. Twice a week the exercise sessions will be supervised by a physiotherapist and these sessions will consist of endurance and strength training. The endurance training will be high intensity interval training on a treadmill. And strength training with external load for the major muscle groups (individually adapted: six exercises, eight to ten repetitions maximum, two to three sets). Once a week the participants will exercise individually for a minimum of 40 minutes of endurance exercise.<br>|
| No Intervention: Control group<br>Participants in the control group will be asked to continue their usual physical activity habits | |

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 (ASDAS) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood samples | General and specific markers of inflammation and cardiovascular risk | 3 months (all analyses) 12 months (only CRP and ESR) | 
| Spinal mobility | The Bath Ankylosing Spondylitis Metrology Index (BASMI). BASMI includes five measurements of flexibility in the spine, neck and hips. | 3 months | 
| Physical function | The Bath Ankylosing Spondylitis functional Index (BASFI). | 3 months and 12 months | 
| Cardiorespiratory fitness | Maximal walking test on a treadmill for estimation of maximal oxygen uptake. | 3 months | 
| Body composition | Body weight, body height, waist and hip circumference. DXA scan of a sample of patients. | 3 months | 
| Arterial stiffness | Pulse wave velocity and argumentation Index | 3 months | 
| Endothelial function | Digital plethysmography using the non-invasive ADMAR apparatus (sample of participants) | 3 months | 
| Blood pressure |  | 3 months | 
| General health | Assessed with the general health questionnaire (GHQ-12) | 3 months and 12 months | 
| Health related quality of life | Euro Quol 5D (EQ5D) | 3 months and 12 months | 
| Physical activity level | Questionaire of frequency, intensity and duration of physical activity | 3 months and 12 months | 
| Self-efficacy for physical activity | Questionnaire | 3 months and 12 months | 
| Fatigue | The fatigue severity scale and the SF-36 vitality scale (version 1) | 3 months and 12 months | 
| Sleep | Pittsburgh Sleep Quality Index (PSQI) | 3 months and 12 months |