Actively Recruiting
A Digital Exercise Intervention in Patients With Spondyloarthritis
Led by Diakonhjemmet Hospital · Updated on 2024-09-19
260
Participants Needed
1
Research Sites
317 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Digital Exercise Intervention in Patients With Spondyloarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of axial spondyloarthritis within the last 2 years by a rheumatologist using ASAS criteria
- Active disease with ankylosing spondylitis disease activity score (ASDAS) greater than 1.3
- Adult participants aged 18 years or older
You will not qualify if you...
- Active uveitis (eye inflammation)
- C-reactive protein (CRP) level greater than 30
- Current or previous use of biologic disease modifying anti-rheumatic drugs (bDMARDs)
- Pregnancy or planning pregnancy within 6 months of enrollment
- Absolute or relative contraindications to high intensity interval training according to American College of Sports Medicine guidelines
- Presence of serious diseases such as cancer
- Inability to follow the study protocol or remote monitoring requirements
AI-Screening
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Trial Site Locations
Total: 1 location
1
Diakonhjemmet hospital
Oslo, Norway
Actively Recruiting
Research Team
S
Sella A Provan, Professor
CONTACT
B
Birgitte Nellemann, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
4
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