Digital exercise program for patients with spondyloarthritis
The SPARK Trial: a Digital Exercise Intervention in Patients With Spondyloarthritis
NA · Diakonhjemmet Hospital · NCT06462937
This study is testing a digital exercise program to see if it helps people with axial spondyloarthritis feel better compared to regular care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Diakonhjemmet Hospital (other) |
| Locations | 1 site (Oslo) |
| Trial ID | NCT06462937 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a 6-month randomized controlled exercise intervention for patients with axial spondyloarthritis (axSpA). Participants will be assigned to either a digital exercise program delivered via the SPARK application, which includes high intensity interval training and personalized remote follow-up, or to usual care. The primary goal is to assess the impact of this tailored exercise program on disease activity, measured by the ankylosing spondylitis disease activity score (ASDAS), at the 3-month mark. The program aims to empower patients through knowledge videos and structured exercise sessions to improve their overall health and well-being.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a recent diagnosis of axial spondyloarthritis and active disease who have not previously used biologic disease-modifying anti-rheumatic drugs.
Not a fit: Patients with active iridocyclitis, high C-reactive protein levels, or contraindications to high intensity exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce disease activity in patients with spondyloarthritis, improving their quality of life.
How similar studies have performed: Other studies have shown promise with digital exercise interventions for chronic conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Oslo
- Diakonhjemmet hospital — Oslo, Norway (RECRUITING)
Study contacts
- Study coordinator: Sella A Provan, Professor
- Email: SellaProvan@gmail.com
- Phone: 4791582581
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spondyloarthritis, Exercise, Remote, Digital, High intensity interval training