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Recruiting NCT06462937

A Digital Exercise Intervention in Patients With Spondyloarthritis

◆ AI Clinical Summary

This study tests whether a 6-month digital exercise program can help reduce disease activity in patients with axial spondyloarthritis. Participants will be randomly assigned to different exercise groups and their disease activity will be measured at 3 months and 6 months.

Key Objective: The trial is testing whether high-intensity digital exercise can reduce disease activity and improve outcomes in patients with axial spondyloarthritis.

Who to Consider: Patients with axial spondyloarthritis who are interested in exploring whether structured digital exercise could help manage their condition should consider enrolling.

Trial Parameters

Condition Spondyloarthritis
Sponsor Diakonhjemmet Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 260
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-07-01
Completion 2027-08-01
Interventions
Exercise with supervisionExercise without supervision

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.

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