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

Diakonhjemmet Hospital100 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Axial Spondyloarthritis

Interventions

ExerciseBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diagnosis of axial SpA (the Assessment of SpondyloArthritis International Society classification criteria) confirmed by a rheumatologist 2. Age, 18-70 -years 3. Steady medication for ≥3 months 4. Moderate disease activity defined as a BASDAI score of ≥3.5 or a patient global score ≥3.5 5. Not participated in a structured endurance and strength exercise program during the last 6 months (\>1 hour/week) Exclusion Criteria: 1. 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 2. Not able to participate in weekly exercises sessions 3. Pregnancy

Locations (4)

Martina Hansens Hospital AS

Bærum, Norway

Diakonhjemmet Hospital AS

Oslo, Norway

University Hospital of North Norway

Tromsø, Norway

University of Gotenburg

Gothenburg, Sweden

Outcomes

Primary Outcomes

Disease activity

The Ankylosing Spondylitis Disease Activity Score (ASDAS) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

Time frame: 3 months

Secondary Outcomes

Blood samples

General and specific markers of inflammation and cardiovascular risk

Time frame: 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.

Time frame: 3 months

Physical function

The Bath Ankylosing Spondylitis functional Index (BASFI).

Time frame: 3 months and 12 months

Cardiorespiratory fitness

Maximal walking test on a treadmill for estimation of maximal oxygen uptake.

Time frame: 3 months

Body composition

Body weight, body height, waist and hip circumference. DXA scan of a sample of patients.

Time frame: 3 months

Arterial stiffness

Pulse wave velocity and argumentation Index

Time frame: 3 months

Endothelial function

Digital plethysmography using the non-invasive ADMAR apparatus (sample of participants)

Time frame: 3 months

Data from ClinicalTrials.gov

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