A Digital Exercise Intervention in Patients With Spondyloarthritis

Recruiting now · Not applicable

Conditions studied: Spondyloarthritis, Exercise

In brief

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.

Key facts

Study ID: NCT06462937
Run by: Diakonhjemmet Hospital
People needed: 260
Starts: 2024-07-01
Expected to finish: 2030-08-01
Last updated by the study team: 2024-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

axSpA diagnosis within the last two years by a rheumatologist according to the ASAS criteria of 2009
active disease (ASDAS > 1.3)

You may not qualify if…

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 it is running

Diakonhjemmet hospital — Oslo, Norway (enrolling)

Full record on ClinicalTrials.gov

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