NCT06462937 A Digital Exercise Intervention in Patients With Spondyloarthritis
| NCT ID | NCT06462937 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Diakonhjemmet Hospital |
| Condition | Spondyloarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 260 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2027-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 260 participants in total. It began in 2024-07-01 with a primary completion date of 2027-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06462937 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spondyloarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06462937 currently recruiting?
Yes, NCT06462937 is actively recruiting participants. Contact the research team at SellaProvan@gmail.com for enrollment information.
Where is the NCT06462937 trial being conducted?
This trial is being conducted at Oslo, Norway.
Who is sponsoring the NCT06462937 clinical trial?
NCT06462937 is sponsored by Diakonhjemmet Hospital. The trial plans to enroll 260 participants.