SpondyloarthritisSPARKNCT06462937
A Digital Exercise Intervention in Patients With Spondyloarthritis
A study testing Exercise with supervision and Exercise without supervision in people with Spondyloarthritis and Exercise, run by Diakonhjemmet Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondyloarthritis, Exercise
- What is being tested?
- Exercise with supervision and Exercise without supervision
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jul 2024to 1 Aug 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- axSpA diagnosis within the last two years by a rheumatologist according to the ASAS criteria of 2009
- active disease (ASDAS > 1.3)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Diakonhjemmet hospital
Oslo
Birgitte Nellemann, 4747957020
About this study
Official title: The SPARK Trial: a Digital Exercise Intervention in Patients With Spondyloarthritis
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.
Read the 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).
- Conditions
- Spondyloarthritis, Exercise
- Being tested
- Exercise with supervision, Exercise without supervision
- Keywords
- Remote, Digital, High intensity interval training
- Medical subject headings
- Spondylarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise with supervisionBehavioural
Remote 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 supervisionBehavioural
Remote 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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise with personal supervision 0-3 months | Experimental | Exercise Receives: Behavioral: Exercise with supervision |
| Control 0-3 months | No intervention | Usual care |
| Exercise with personal supervision 3-6 months | Experimental | Exercise Receives: Behavioral: Exercise with supervision |
| Exercise without personal supervision 3-6 months | Active comparator | Exercise Receives: Behavioral: Exercise without supervision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease activity 3 months
Number of participants in ASDAS inactive (ASDAS < 1.3) at 3 months
Measured: 3 months
Secondary outcomes (24)
Biologic disease modifying anti-rheumatic drugs 3 months
Number of participants on biologic disease modifying anti-rheumatic drugs (bDMARD) at 3 months
Measured: 3 months
Disease activity 6 months
Number of participants in ankylosing spondylitis disease activity score (ASDAS) inactive (ASDAS < 1.3) at 6 months
Measured: 6 months
Proportion of participants using non-steroidal anti-inflammatory drugs
Usage of non-steroidal anti-inflammatory drugs (NSAIDs)
Measured: 3 and 6 months
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
Measured: 3 and 6 months
Bath ankylosing spondylitis function index
Physical function measured by Bath ankylosing spondylitis function index (BASFI). Scale range 0-10, where 0= no functional impairment 10=very significant impairment
Measured: 3 and 6 months
Ankylosing spondylitis Performance Index
Physical function measured by Ankylosing spondylitis Performance Index (ASPI). Continuous variable in units of minutes. The functional level is inversely proportional to the number of minutes.
Measured: 3 and 6 months
Physical fitness
Indirect exercise test on a tread-mill until exhaustion. Measured in oxygen uptake ml/min/kg.
Measured: 3 and 6 months
Physiological effects of exercise on inflammation measured by CRP
Effect of exercise on CRP
Measured: 3 and 6 months
Physiological effects of exercise on blood pressure
Effect of exercise on blood pressure
Measured: 3 and 6 months
Physiological effects of exercise on weight
Effect of exercise on weight in kg
Measured: 3 and 6 months
Physiological effects of exercise on muscle mass
Effect of exercise on body composition measured as percentage muscle mass
Measured: 3 and 6 months
Physiological effects of exercise on adipose tissue
Effect of exercise on body composition measured as percentage adipose tissue
Measured: 3 and 6 months
Safety measures of exercise Spine
Safety measures: MRI spine in a subset of participants at baseline and after 3 months of exercise. Level of inflammation scored by Canadian Spondyloarthritis Research Consortium score (SPARCC). High score represents more inflammation. The minimum score 0, max score 108
Measured: 3 and 6 months
Safety measures of exercise Sacroiliac joints
Safety measures: MRI sacroiliac joints in a subset of participants at baseline and after 3 months of exercise. Level of inflammation scored by Canadian Spondyloarthritis Research Consortium (SPARCC). High score represents more inflammation. The minimum score 0, max score 72
Measured: 3 and 6 months
Effects of exercise on mental wellbeing
Quality of life Warwick Edinburgh Mental Wellbeing Scale WEMWBS). Range 14-70. A higher score indicates greater mental well-being
Measured: 3 and 6 months
Effects of exercise on quality of life
Quality of life EQ5D. Range -0.59 to 1, where 1 is the best possible health state
Measured: 3 and 6 months
Work presenteeism
Health economy measures: work presenteeism expressed in percentage (%) measured by Work Productivity and Activity Impairment Questionnaire (WPAI)
Measured: 3 and 6 months
Work absenteeism
Health economy measures: work absenteeism expressed in percentage (%) measured by Work Productivity and Activity Impairment Questionnaire (WPAI)
Measured: 3 and 6 months
Work impairment
Health economy measures: work overall impairment expressed in percentage (%) measured by Work Productivity and Activity Impairment Questionnaire (WPAI)
Measured: 3 and 6 months
Functional impairment
Health economy measures: functional impairment expressed in percentage (%) measured by Work Productivity and Activity Impairment Questionnaire (WPAI)
Measured: 3 and 6 months
Contact with the Healthcare services
Health economy measures: Contact with the health care services. Self reported as number of visits to general practitioner, specialist healthcare and/or physiotherapist during past 3 months
Measured: 3 and 6 months
Sleep quality
Questionnaire on sleep quality: Pittsburgh Sleep Questionnaire. Global score ranges from 0 to 21 and higher scores indicate poorer sleep quality.
Measured: 3 and 6 months
Physical activity level
Physical activity level measured for one week at baseline, 3 months and 6 months by a movement sensor. (Actigraph). The score will be presented as Metabolic Equivalents. A high score represents more movement
Measured: Baseline, 3 and 6 months
Adverse events
We collect information of adverse events including any discomfort, muscle pain, joint pain, joint swallowing, dyspnoe, chest pain, ancle sprain, pain in a muscle group, pain in entheses, broken bones, infections. Participants report every 4 weeks through out the study, and SPARK coaches report for the participants at every follow-up.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Jul 2024
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SpondyloarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462937
- Sponsor's protocol ID
- DS00735
- Acronym
- SPARK
- Status last verified
- Aug 2026
- First submitted
- 13 May 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will only be shared upon resonable request
Publications
Nellemann B, Fongen C, Dagfinrud H, Berg IJ, Kristianslund EK, Sexton J, Norden KR, Lillegraven S, Osteras N, Jorgensen TS, Carmona L, Sveaas SH, Provan SA. Remote personalised exercise in axial spondyloarthritis: the SPARK trial - protocol for a 6-month randomised controlled trial. BMJ Open. 2026 Mar 30;16(3):e112420. doi: 10.1136/bmjopen-2025-112420.
PubMed 41916634