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Remote personalised exercise in axial spondyloarthritis: the SPARK trial - protocol for a 6-month randomised
Birgitte Nellemann1, Camilla Fongen1,2, Hanne Dagfinrud1
1Centre for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway.
Introduction:
Current international guidelines recommend exercise as a first-line treatment of axial spondyloarthritis (SpA). However, there is no consensus on the mode and volume required to effectively reduce disease activity. It is advised that exercise for patients with SpA align with recommendations for the general population. For exercise to be sustainable and beneficial, it must be integrated into daily life and strategies to ensure long-term commitment are essential. The SpA Kardio (SPARK) trial aims to assess the impact of a remote, individually tailored exercise programme in patients with SpA with the proportion of patients reaching Axial Spondyloarthritis Disease Activity Score (ASDAS) inactive at 3 months as the primary outcome. The exercise includes high-intensity cardiorespiratory intervals and muscle strength exercises, with digital follow-up and monitoring, in patients with SpA. The SPARK programme includes regular supervision, personalised follow-up, goal-setting and education delivered through an application available on smartphones or tablets.
Methods And Analysis:
The SPARK trial is a randomised controlled superiority trial. Individuals recently diagnosed with SpA by a rheumatologist with disease activity measured by the ASDAS ≥1.3 who have not used biological disease-modifying antirheumatic drugs (bDMARDs) are eligible for inclusion. Consenting individuals will be randomised to treatment as usual (n=130) or the SPARK programme (n=130) with 12-week duration. After 12 weeks, all participants will be rerandomised to either a supervised or an unsupervised SPARK programme for weeks 12-24. The primary outcome will be achievement of an inactive disease state (ASDAS <1.3) at week 12 in each group. Secondary outcomes include use of medication (bDMARDs and non-steroidal anti-inflammatory drugs (NSAIDs)), cardiorespiratory fitness, muscle strength, sleep quality and quantity, health-related quality of life, work participation, adverse events and disease activity at week 24 (ASDAS and the Bath Ankylosing Spondylitis Disease Activity Index). MRI of the lumbar spine and sacroiliac joints at baseline and full-body dual-energy X-ray absorptiometry will be performed in a subgroup.
Ethics And Dissemination:
The SPARK trial is approved by Regional Committee for Medical and Health Research Ethics in South-Eastern Norway (#684555). The SPARK trial will contribute important knowledge on effects of a tailored digital exercise programme with monitored remote follow-up in patients with SpA and may improve the initial care of patients in terms of disease activity and ensure use of bDMARDs according to modern guidelines.
Trial Registration Number:
NCT06462937.
