Axial Spondyloarthritis
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALExercise
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.
Sponsors
University of Oslo
Norwegian School of Sport Sciences
Diakonhjemmet Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease activity | 3 months | The Ankylosing Spondylitis Disease Activity Score (ASDAS) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spinal mobility | 3 months | The Bath Ankylosing Spondylitis Metrology Index (BASMI). BASMI includes five measurements of flexibility in the spine, neck and hips. |
| Physical function | 3 months and 12 months | The Bath Ankylosing Spondylitis functional Index (BASFI). |
| Cardiorespiratory fitness | 3 months | Maximal walking test on a treadmill for estimation of maximal oxygen uptake. |
| Body composition | 3 months | Body weight, body height, waist and hip circumference. DXA scan of a sample of patients. |
| Arterial stiffness | 3 months | Pulse wave velocity and argumentation Index |
| Endothelial function | 3 months | Digital plethysmography using the non-invasive ADMAR apparatus (sample of participants) |
| Blood samples | 3 months (all analyses) 12 months (only CRP and ESR) | General and specific markers of inflammation and cardiovascular risk |
| General health | 3 months and 12 months | Assessed with the general health questionnaire (GHQ-12) |
| Health related quality of life | 3 months and 12 months | Euro Quol 5D (EQ5D) |
| Physical activity level | 3 months and 12 months | Questionaire of frequency, intensity and duration of physical activity |
| Self-efficacy for physical activity | 3 months and 12 months | Questionnaire |
| Fatigue | 3 months and 12 months | The fatigue severity scale and the SF-36 vitality scale (version 1) |
| Sleep | 3 months and 12 months | Pittsburgh Sleep Quality Index (PSQI) |
| Blood pressure | 3 months | — |
Countries
Norway, Sweden
Outcome results
None listed