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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
260
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.
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.
Diakonhjemmet hospital
Oslo, Norway
RECRUITINGDisease activity 3 months
Number of participants in ASDAS inactive (ASDAS \< 1.3) at 3 months
Time frame: 3 months
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 months
Disease activity 6 months
Number of participants in ankylosing spondylitis disease activity score (ASDAS) inactive (ASDAS \< 1.3) at 6 months
Time frame: 6 months
Proportion of participants using non-steroidal anti-inflammatory drugs
Usage of non-steroidal anti-inflammatory drugs (NSAIDs)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 3 and 6 months
Physical fitness
Indirect exercise test on a tread-mill until exhaustion. Measured in oxygen uptake ml/min/kg.
Time frame: 3 and 6 months
Physiological effects of exercise on inflammation measured by CRP
Effect of exercise on CRP
Time frame: 3 and 6 months
Physiological effects of exercise on blood pressure
Effect of exercise on blood pressure
Time frame: 3 and 6 months
Physiological effects of exercise on weight
Effect of exercise on weight in kg
Time frame: 3 and 6 months
Physiological effects of exercise on muscle mass
Effect of exercise on body composition measured as percentage muscle mass
Time frame: 3 and 6 months
Physiological effects of exercise on adipose tissue
Effect of exercise on body composition measured as percentage adipose tissue
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 and 6 months
Work presenteeism
Health economy measures: work presenteeism expressed in percentage (%) measured by Work Productivity and Activity Impairment Questionnaire (WPAI)
Time frame: 3 and 6 months
Work absenteeism
Health economy measures: work absenteeism expressed in percentage (%) measured by Work Productivity and Activity Impairment Questionnaire (WPAI)
Time frame: 3 and 6 months
Work impairment
Health economy measures: work overall impairment expressed in percentage (%) measured by Work Productivity and Activity Impairment Questionnaire (WPAI)
Time frame: 3 and 6 months
Functional impairment
Health economy measures: functional impairment expressed in percentage (%) measured by Work Productivity and Activity Impairment Questionnaire (WPAI)
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 6 months
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