Clinical trial NCT06462937: A Digital Exercise Intervention in Patients With Spondyloarthritis
Official title: The SPARK Trial: a Digital Exercise Intervention in Patients With Spondyloarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spondyloarthritis
Exercise
Keywords: Remote
Digital
High intensity interval training
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Baseline: randomization to intervention (Exercise) or control (Usual care) 1:1.

3 months: randomization to intervention (Exercise remotely delivered plan with personalised weekly follow-up) or control (Exercise remotely delivered plan without weekly follow-up)
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Main objectives: To assess if a digital personally tailored exercise program with remote follow-up can reduce disease activity measured by ankylosing spondylitis disease activity score (ASDAS) in patients with recently diagnosed axial spondyloarthritis (axSpA).

Main inclusion criteria Adults (\> 18 years) with clinical diagnosis from a rheumatologist of axSpA within the last 2 years of inclusion also fulfilling the ankylosing spondylitis disease activity score (ASAS) classification criteria, who are biologic disease modifying anti-rheumatic drugs (bDMARD) naïve, and have an active disease (ASDAS ≥ 1.3)

Main exclusion criteria:

Active iridocyclitis, c-reactive protein (CRP) \> 30, contraindication to high intensity interval training

Primary outcome Proportion of participants in ASDAS inactive (ASDAS \< 1.3) at 3 months

Number of participants: 260 (with an anticipated drop-out rate of 15%)

Study design: A two-arm multi-centre, clinical trial, randomization 1:1 to either digital exercise intervention with remote follow-up or usual care.

Intervention: Exercise delivered through an application and with personalised follow-up by a coach through remote sessions (the participant and SPARK-coach are not at the same physical location) weekly. The exercise is progressively tailored to the fitness level of each participant. The program consists of 5 session per week on 3 different days including: two sessions with HIIT, 2 sessions with strength exercise, and one session with an aerobic exercise at moderate intensity. Goal for HIIT is 10 minutes two times per week at 85-95% of maximal heart rate (20 minutes in total). The exercise will be performed at a location of the participants' choice and data will be logged by a sports watch.

Efficacy assessments: ASDAS disease activity measure (4 patient reported questions and measure of CRP), Bath ankylosing spondylitis disease activity index (BASDAI).

Physical measure: cardiorespiratory fitness, in a subset of participants direct cardiopulmonary testing, muscular strength tests.

Psychological measures: Warwick and Edinburgh mental wellbeing scale (WEMWBS), EuroQol (EQ5D).

Medication: use of bDMARDs, use of NSAID

Safety assessments General physical examination and vital signs, laboratory tests as a part of usual clinical care, record of adverse events and serious adverse events, magnetic resonance imaging (MRI).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Disease activity 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Biologic disease modifying anti-rheumatic drugs 3 months
timeFrame: 3 months
measure: Disease activity 6 months
timeFrame: 6 months
measure: Proportion of participants using non-steroidal anti-inflammatory drugs
timeFrame: 3 and 6 months
measure: Bath ankylosing spondylitis metrology index
timeFrame: 3 and 6 months
measure: Bath ankylosing spondylitis function index
timeFrame: 3 and 6 months
measure: Ankylosing spondylitis Performance Index
timeFrame: 3 and 6 months
measure: Physical fitness
timeFrame: 3 and 6 months
measure: Physiological effects of exercise on lipids
timeFrame: 3 and 6 months
measure: Physiological effects of exercise on inflammation measured by CRP
timeFrame: 3 and 6 months
measure: Physiological effects of exercise on blood pressure
timeFrame: 3 and 6 months
measure: Physiological effects of exercise on weight
timeFrame: 3 and 6 months
measure: Physiological effects of exercise on muscle mass
timeFrame: 3 and 6 months
measure: Physiological effects of exercise on adipose tissue
timeFrame: 3 and 6 months
measure: Safety measures of exercise Spine
timeFrame: 3 and 6 months
measure: Safety measures of exercise Sacroiliac joints
timeFrame: 3 and 6 months
measure: Effects of exercise on mental wellbeing
timeFrame: 3 and 6 months
measure: Effects of exercise on quality of life
timeFrame: 3 and 6 months
measure: Work presenteeism
timeFrame: 3 and 6 months
measure: Work absenteeism
timeFrame: 3 and 6 months
measure: Work impairment
timeFrame: 3 and 6 months
measure: Functional impairment
timeFrame: 3 and 6 months
measure: Contact with the Healthcare services
timeFrame: 3 and 6 months
measure: Sleep quality
timeFrame: 3 and 6 months
measure: Physical activity level
timeFrame: Baseline, 3 and 6 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Diakonhjemmet hospital
Study officials:
References: