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| Name | Class |
|---|---|
| University of Oslo | OTHER |
| Norwegian School of Sport Sciences | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise group | Experimental | Exercise |
|
| Control group | No Intervention | Participants in the control group will be asked to continue their usual physical activity habits |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease activity | The Ankylosing Spondylitis Disease Activity Score (ASDAS) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | 3 months |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hanne H Dagfinrud, PhD | Nationonal Advisory Unit on Rehabilitation in Rheumatology, Departement of Rheumatology, Diakonhjemmet Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Martina Hansens Hospital AS | Bærum | 1306 | Norway | |||
| Diakonhjemmet Hospital AS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38095452 | Derived | Fongen C, Dagfinrud H, Bilberg A, Sveaas SH. Reduced sleep quality is highly prevalent and associated with physical function and cardiorespiratory fitness in patients with axial spondyloarthritis: a cross-sectional study. Scand J Rheumatol. 2024 Mar;53(2):130-139. doi: 10.1080/03009742.2023.2281069. Epub 2023 Dec 14. | |
| 33423392 | Derived |
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| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| 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 |
| Oslo |
| 0319 |
| Norway |
| University Hospital of North Norway | Tromsø | 9038 | Norway |
| University of Gotenburg | Gothenburg | Sweden |
| Bilberg A, Dagfinrud H, Sveaas SH. Supervised Intensive Exercise for Strengthening Exercise Health Beliefs in Patients With Axial Spondyloarthritis: A Multicenter Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2022 Jul;74(7):1196-1204. doi: 10.1002/acr.24556. Epub 2022 Apr 17. |
| 32367124 | Derived | Sveaas SH, Dagfinrud H, Berg IJ, Provan SA, Johansen MW, Pedersen E, Bilberg A. High-Intensity Exercise Improves Fatigue, Sleep, and Mood in Patients With Axial Spondyloarthritis: Secondary Analysis of a Randomized Controlled Trial. Phys Ther. 2020 Aug 12;100(8):1323-1332. doi: 10.1093/ptj/pzaa086. |
| 31944251 | Derived | Fongen C, Dagfinrud H, Bilberg A, Pedersen E, Johansen MW, van Weely S, Hagen KB, Sveaas SH. Responsiveness and Interpretability of 2 Measures of Physical Function in Patients With Spondyloarthritis. Phys Ther. 2020 Apr 17;100(4):728-738. doi: 10.1093/ptj/pzaa004. |
| 31732552 | Derived | Sveaas SH, Dagfinrud H, Johansen MW, Pedersen E, Wold OM, Bilberg A. Longterm Effect on Leisure Time Physical Activity Level in Individuals with Axial Spondyloarthritis: Secondary Analysis of a Randomized Controlled Trial. J Rheumatol. 2020 Aug 1;47(8):1189-1197. doi: 10.3899/jrheum.190317. Epub 2019 Nov 15. |
| 30745314 | Derived | Sveaas SH, Bilberg A, Berg IJ, Provan SA, Rollefstad S, Semb AG, Hagen KB, Johansen MW, Pedersen E, Dagfinrud H. High intensity exercise for 3 months reduces disease activity in axial spondyloarthritis (axSpA): a multicentre randomised trial of 100 patients. Br J Sports Med. 2020 Mar;54(5):292-297. doi: 10.1136/bjsports-2018-099943. Epub 2019 Feb 11. |
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |