A Digital Exercise Intervention in Patients With Spondyloarthritis
NCT Number: NCT06462937
Acronym: SPARK
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Spondyloarthritis|Exercise
Interventions: BEHAVIORAL: Exercise with supervision|BEHAVIORAL: Exercise without supervision
Sponsor: Diakonhjemmet Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 260
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-01
Completion Date: 2030-08-01
Locations: Diakonhjemmet hospital, Oslo, Norway

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.

Primary Outcome Measures: Disease activity 3 months, Number of participants in ASDAS inactive (ASDAS \< 1.3) at 3 months, 3 months
Secondary Outcome Measures: Biologic disease modifying anti-rheumatic drugs 3 months, Number of participants on biologic disease modifying anti-rheumatic drugs (bDMARD) at 3 months, 3 months|Disease activity 6 months, Number of participants in ankylosing spondylitis disease activity score (ASDAS) inactive (ASDAS \< 1.3) at 6 months, 6 months|Proportion of participants using non-steroidal anti-inflammatory drugs, Usage of non-steroidal anti-inflammatory drugs (NSAIDs), 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, 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, 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., 3 and 6 months|Physical fitness, Indirect exercise test on a tread-mill until exhaustion. Measured in oxygen uptake ml/min/kg., 3 and 6 months|Physiological effects of exercise on lipids, Effect of exercise on lipids, 3 and 6 months|Physiological effects of exercise on inflammation measured by CRP, Effect of exercise on CRP, 3 and 6 months|Physiological effects of exercise on blood pressure, Effect of exercise on blood pressure, 3 and 6 months|Physiological effects of exercise on weight, Effect of exercise on weight in kg, 3 and 6 months|Physiological effects of exercise on muscle mass, Effect of exercise on body composition measured as percentage muscle mass, 3 and 6 months|Physiological effects of exercise on adipose tissue, Effect of exercise on body composition measured as percentage adipose tissue, 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, 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, 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, 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, 3 and 6 months|Work presenteeism, Health economy measures: work presenteeism expressed in percentage (%) measured by Work Productivity and Activity Impairment Questionnaire (WPAI), 6 months|Work absenteeism, Health economy measures: work absenteeism expressed in percentage (%) measured by Work Productivity and Activity Impairment Questionnaire (WPAI), 6 months|Work impairment, Health economy measures: work overall impairment expressed in percentage (%) measured by Work Productivity and Activity Impairment Questionnaire (WPAI), 6 months|Functional impairment, Health economy measures: functional impairment expressed in percentage (%) measured by Work Productivity and Activity Impairment Questionnaire (WPAI), 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, 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., 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, Baseline, 3 and 6 months