Remote personalised exercise in axial spondyloarthritis: the SPARK trial - protocol for a 6-month randomised controlled trial.
Birgitte Nellemann, Camilla Fongen, Hanne Dagfinrud...
https://pubmed.ncbi.nlm.nih.gov/41916634Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06462937
The SPARK Trial: A Digital Exercise Intervention for Patients With Spondyloarthritis
Led by Diakonhjemmet Hospital · Updated on 2024-09-19
260
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a digital, personalized exercise program designed to reduce disease activity in adults recently diagnosed with axial spondyloarthritis (axSpA). This controlled trial assesses whether remote exercise supervision through the SPARK app, combined with patient education videos, can improve health outcomes. The study compares this approach to usual care in patients who have not used biologic disease modifying anti-rheumatic drugs and who have active disease. Participants will be randomly assigned to one of two groups: one receiving a personalized exercise program with remote coaching and another receiving usual care. The exercise program includes high intensity interval training (HIIT), muscular strength exercises, and moderate aerobic activity spread over three days per week, with the goal of 20 minutes of HIIT weekly at 85-95% of maximal heart rate. The program is remotely delivered via the SPARK application, with weekly coaching sessions and exercise data tracked by a sports watch. Throughout the 6-month trial, participants undergo assessments including disease activity measures like ASDAS and BASDAI, physical fitness tests, psychological wellbeing scales, and safety evaluations with physical exams and MRI scans. Medication use and adverse events are also monitored. The primary outcome is disease activity at 3 months, with further evaluations at 6 months to measure the effects of the exercise intervention on health, wellbeing, and physical function.
CONDITIONS
Brief Title
A Digital Exercise Intervention in Patients With Spondyloarthritis
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of axial spondyloarthritis by a rheumatologist within the last two years according to ASAS 2009 criteria
- Active disease with ankylosing spondylitis disease activity score (ASDAS) greater than 1.3
- Age 18 years or older
- Biologic disease modifying anti-rheumatic drugs (bDMARD) naive
You will not qualify if you...
- Active uveitis (eye inflammation)
- C-reactive protein (CRP) level greater than 30
- Current or past use of biologic disease modifying anti-rheumatic drugs (bDMARDs)
- Pregnancy or planned pregnancy within 6 months of enrollment
- Absolute or relative contraindications to high intensity exercise according to ACSM guidelines
- Presence of other serious diseases such as cancer
- Inability to follow the study protocol or remote monitoring procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - 3 months per treatment period
Participants engage in a digital exercise program with or without remote supervision. Exercise sessions occur 3 to 5 times per week, including high intensity interval training, strength, and aerobic exercises. The program is progressively tailored to fitness levels and performed at a location of the participant's choice.
Weekly remote sessions with a coach for supervised group; no direct contact for unsupervised group
Outpatient Treatment
Duration - 3 months
Participants continue with the second 3-month phase of the digital exercise program, either with personal supervision or without, depending on randomization crossover assignment.
Weekly remote sessions with a coach for supervised group; no direct contact for unsupervised group
Follow-up
Duration - Up to 6 months total from start
Participants are monitored for disease activity, physical fitness, psychological wellbeing, and safety outcomes following the completion of the exercise interventions.
Visits at baseline, 3 months, and 6 months for assessments
Trial Site Locations
Total: 1 location
1
Diakonhjemmet hospital
Oslo, Norway
Actively Recruiting
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Research Team
S
Sella A Provan, Professor
B
Birgitte Nellemann, PhD
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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