Clinical trial NCT02356874: The Effect of Exercise on Disease Activity and Cardiovascular Risk for Patients With Axial SpondyloArthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Axial Spondyloarthritis
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Norwegian School of Sport Sciences
First posted: 2015-02-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease activity
timeFrame: 3 months
Secondary outcomes:
measure: Blood samples
timeFrame: 3 months (all analyses) 12 months (only CRP and ESR)
measure: Spinal mobility
timeFrame: 3 months
measure: Physical function
timeFrame: 3 months and 12 months
measure: Cardiorespiratory fitness
timeFrame: 3 months
measure: Body composition
timeFrame: 3 months
measure: Arterial stiffness
timeFrame: 3 months
measure: Endothelial function
timeFrame: 3 months
measure: Blood pressure
timeFrame: 3 months
measure: General health
timeFrame: 3 months and 12 months
measure: Health related quality of life
timeFrame: 3 months and 12 months
measure: Physical activity level
timeFrame: 3 months and 12 months
measure: Self-efficacy for physical activity
timeFrame: 3 months and 12 months
measure: Fatigue
timeFrame: 3 months and 12 months
measure: Sleep
timeFrame: 3 months and 12 months
Other outcomes:
Locations:
city: Bærum
country: Norway
facility: Martina Hansens Hospital AS
city: Oslo
country: Norway
facility: Diakonhjemmet Hospital AS
city: Tromsø
country: Norway
facility: University Hospital of North Norway
city: Gotenburg
country: Sweden
facility: University of Gotenburg
Study officials:
affiliation: Nationonal Advisory Unit on Rehabilitation in Rheumatology, Departement of Rheumatology, Diakonhjemmet Hospital
name: Hanne H Dagfinrud, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.