A Digital Exercise Intervention in Patients With Spondyloarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDiakonhjemmet Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
axSpA diagnosis within the last two years by a rheumatologist according to the ASAS criteria of 2009
active disease (ASDAS > 1.3)
Disqualifiers
Active uveitis.
CRP > 30.
Former or current use of bDMARDs.
Pregnancy or planned pregnancy within 6 months from inclusion.
Trial design
Design model
Crossover
Treatments tested in this trial
Exercise with supervision
BehavioralRemote exercise will be administered with digital supervision. The Exercise group will receive a personalised program with individual adaptations aiming to perform 3 exercise sessions per week including HIIT, strength exercise and moderate intensive aerobic exercise. Participants will consult their rheumatologist parallel to the SPARK trial.
Exercise without supervision
BehavioralRemote exercise will be administered without digital supervision. Participants will receive a standard exercise program fulfilling the exercise protocol requirements, the exercise program will progress. But there will be no direct contact between the participant and the coach. Participants will consult their rheumatologist parallel to the SPARK trial.
Treatment groups
260 Participants
are divided into 4 treatment groupsGroup A: Exercise with personal supervision 0-3 monthsExperimental treatment 1 intervention
Group B: Control 0-3 monthsNo intervention 0 interventions
Group C: Exercise with personal supervision 3-6 monthsExperimental treatment 1 intervention
Group D: Exercise without personal supervision 3-6 monthsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Disease activity 3 months
Number of participants in ASDAS inactive (ASDAS \< 1.3) at 3 months
Time frame
3 monthsSecondary outcomes
1
Biologic disease modifying anti-rheumatic drugs 3 months
Number of participants on biologic disease modifying anti-rheumatic drugs (bDMARD) at 3 months
Time frame
3 months2
Disease activity 6 months
Number of participants in ankylosing spondylitis disease activity score (ASDAS) inactive (ASDAS \< 1.3) at 6 months
Time frame
6 months3
Proportion of participants using non-steroidal anti-inflammatory drugs
Usage of non-steroidal anti-inflammatory drugs (NSAIDs)
Time frame
3 and 6 months4
Bath ankylosing spondylitis metrology index
Physical function measured by Bath ankylosing spondylitis metrology index (BASMI). Range 0-10 where 0= no functional impairment 10=very significant impairment
Time frame
3 and 6 monthsOther outcomes
1
Adherence to exercise protocol
Thorugh data collection with sports watch, blue tooth technology and the SPARK app we collect the pulse level during the aerobic exercises. Additionnally participants and physiotehrapist record exercises and work-load of the strentgh exercises directly in the SPARK app.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov