A Digital Exercise Intervention in Patients With Spondyloarthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise with supervision, Exercise without supervision.
- Who it may be relevant to
- Registry conditions: Spondyloarthritis, Exercise. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The SPARK Trial: a Digital Exercise Intervention in Patients With Spondyloarthritis
Overview
This protocol describes a 6-month randomised, controlled exercise trial in patients with axial spondyloarthritis (axSpA) with re-randomization after 3-months. The primary outcome of the trial (disease activity) will be evaluated at 3-months. The exercise programme on trial comprises high intensity interval training (HIIT), muscular strength exercise and aerobic physical activity sessions of specified duration, frequency, and intensity. It also includes brief knowledge videos to empower the patient. The intervention is remotely delivered by the SPARK application with personalised follow-up including monitoring to ensure exercise progression and adherence to exercise intensity. The SPARK application is built on a platform delivered by ABEL Technologies (trademark) and is customised for patients with axSpA.
Detailed description
Main objectives: To assess if a digital personally tailored exercise program with remote follow-up can reduce disease activity measured by ankylosing spondylitis disease activity score (ASDAS) in patients with recently diagnosed axial spondyloarthritis (axSpA).
Main inclusion criteria Adults (\> 18 years) with clinical diagnosis from a rheumatologist of axSpA within the last 2 years of inclusion also fulfilling the ankylosing spondylitis disease activity score (ASAS) classification criteria, who are biologic disease modifying anti-rheumatic drugs (bDMARD) naïve, and have an active disease (ASDAS ≥ 1.3)
Main exclusion criteria:
Active iridocyclitis, c-reactive protein (CRP) \> 30, contraindication to high intensity interval training
Primary outcome Proportion of participants in ASDAS inactive (ASDAS \< 1.3) at 3 months
Number of participants: 260 (with an anticipated drop-out rate of 15%)
Study design: A two-arm multi-centre, clinical trial, randomization 1:1 to either digital exercise intervention with remote follow-up or usual care.
Intervention: Exercise delivered through an application and with personalised follow-up by a coach through remote sessions (the participant and SPARK-coach are not at the same physical location) weekly. The exercise is progressively tailored to the fitness level of each participant. The program consists of 5 session per week on 3 different days including: two sessions with HIIT, 2 sessions with strength exercise, and one session with an aerobic exercise at moderate intensity. Goal for HIIT is 10 minutes two times per week at 85-95% of maximal heart rate (20 minutes in total). The exercise will be performed at a location of the participants' choice and data will be logged by a sports watch.
Efficacy assessments: ASDAS disease activity measure (4 patient reported questions and measure of CRP), Bath ankylosing spondylitis disease activity index (BASDAI).
Physical measure: cardiorespiratory fitness, in a subset of participants direct cardiopulmonary testing, muscular strength tests.
Psychological measures: Warwick and Edinburgh mental wellbeing scale (WEMWBS), EuroQol (EQ5D).
Medication: use of bDMARDs, use of NSAID
Safety assessments General physical examination and vital signs, laboratory tests as a part of usual clinical care, record of adverse events and serious adverse events, magnetic resonance imaging (MRI).
Interventions
- Behavioral Exercise with supervision
Remote exercise will be administered with digital supervision. The Exercise group will receive a personalised program with individual adaptations aiming to perform 3 exercise sessions per week including HIIT, strength exercise and moderate intensive aerobic exercise. Participants will consult their rheumatologist parallel to the SPARK trial. - Behavioral Exercise without supervision
Remote exercise will be administered without digital supervision. Participants will receive a standard exercise program fulfilling the exercise protocol requirements, the exercise program will progress. But there will be no direct contact between the participant and the coach. Participants will consult their rheumatologist parallel to the SPARK trial.
Primary outcome measures
- Disease activity 3 months [Time frame: 3 months]
Secondary outcome measures (12)
- Biologic disease modifying anti-rheumatic drugs 3 months [Time frame: 3 months]
- Disease activity 6 months [Time frame: 6 months]
- Proportion of participants using non-steroidal anti-inflammatory drugs [Time frame: 3 and 6 months]
- Bath ankylosing spondylitis metrology index [Time frame: 3 and 6 months]
- Bath ankylosing spondylitis function index [Time frame: 3 and 6 months]
- Ankylosing spondylitis Performance Index [Time frame: 3 and 6 months]
- Physical fitness [Time frame: 3 and 6 months]
- Physiological effects of exercise on lipids [Time frame: 3 and 6 months]
- Physiological effects of exercise on inflammation measured by CRP [Time frame: 3 and 6 months]
- Physiological effects of exercise on blood pressure [Time frame: 3 and 6 months]
- Physiological effects of exercise on weight [Time frame: 3 and 6 months]
- Physiological effects of exercise on muscle mass [Time frame: 3 and 6 months]
Eligibility criteria
Inclusion criteria
- axSpA diagnosis within the last two years by a rheumatologist according to the ASAS criteria of 2009
- active disease (ASDAS > 1.3)
Exclusion criteria
- Active uveitis.
- CRP > 30.
- Former or current use of bDMARDs.
- Pregnancy or planned pregnancy within 6 months from inclusion.
- Absolute and relative contradictions to high intensity exercise according to the American College of Sports Medicine (ACSM)
- Other serious disease such as cancer.
- Patients incapable to follow the protocol or the control set-up with remote monitoring.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Norway · 1 center
- Diakonhjemmet hospital — Oslo
Publications
- Nellemann B, Fongen C, Dagfinrud H, Berg IJ, Kristianslund EK, Sexton J, Norden KR, Lillegraven S, Osteras N, Jorgensen TS, Carmona L, Sveaas SH, Provan SA. Remote personalised exercise in axial spondyloarthritis: the SPARK trial - protocol for a 6-month randomised controlled trial. BMJ Open. 2026 Mar 30;16(3):e112420. doi: 10.1136/bmjopen-2025-112420. PMID 41916634
Identifiers
NCT: NCT06462937 · DS00735