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A Digital Exercise Intervention in Patients With Spondyloarthritis

Study acronym: SPARK
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Secondary endpoints revised (24)v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 1, 2024 to Jul 1, 2024
    • Secondary endpoints: details revised at 5 of 24 entries
    • Site details revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06462937
Lead Sponsor Diakonhjemmet Hospital
Conditions
(from sponsor)		 Spondyloarthritis, Exercise
Related terms Motor Activity, Spondylarthritis
Enrollment 260 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov