Exercise, Spondyloarthritis
Conditions
Keywords
Remote, Digital, High intensity interval training
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).
Interventions
BEHAVIORALExercise with supervision
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.
BEHAVIORALExercise without supervision
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.
Sponsors
Diakonhjemmet Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
The randomization is performed by a study personnel not involved in data collection. Patients are asked not to inform their care-giver or the physiotherapist who perform the study tests which group the patient is allocated to.
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)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease activity 3 months | 3 months | Number of participants in ASDAS inactive (ASDAS \< 1.3) at 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety measures of exercise Spine | 3 and 6 months | 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 |
| Safety measures of exercise Sacroiliac joints | 3 and 6 months | 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 |
| Effects of exercise on mental wellbeing | 3 and 6 months | Quality of life Warwick Edinburgh Mental Wellbeing Scale WEMWBS). Range 14-70. A higher score indicates greater mental well-being |
| Effects of exercise on quality of life | 3 and 6 months | Quality of life EQ5D. Range -0.59 to 1, where 1 is the best possible health state |
| Work presenteeism | 3 and 6 months | Health economy measures: work presenteeism expressed in percentage (%) measured by Work Productivity and Activity Impairment Questionnaire (WPAI) |
| Work absenteeism | 3 and 6 months | Health economy measures: work absenteeism expressed in percentage (%) measured by Work Productivity and Activity Impairment Questionnaire (WPAI) |
| Work impairment | 3 and 6 months | Health economy measures: work overall impairment expressed in percentage (%) measured by Work Productivity and Activity Impairment Questionnaire (WPAI) |
| Functional impairment | 3 and 6 months | Health economy measures: functional impairment expressed in percentage (%) measured by Work Productivity and Activity Impairment Questionnaire (WPAI) |
| Contact with the Healthcare services | 3 and 6 months | 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 |
| Sleep quality | 3 and 6 months | Questionnaire on sleep quality: Pittsburgh Sleep Questionnaire. Global score ranges from 0 to 21 and higher scores indicate poorer sleep quality. |
| Physical activity level | Baseline, 3 and 6 months | 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 |
| Adverse events | 6 months | 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. |
| Physiological effects of exercise on inflammation measured by CRP | 3 and 6 months | Effect of exercise on CRP |
| Physiological effects of exercise on blood pressure | 3 and 6 months | Effect of exercise on blood pressure |
| Physiological effects of exercise on weight | 3 and 6 months | Effect of exercise on weight in kg |
| Physiological effects of exercise on muscle mass | 3 and 6 months | Effect of exercise on body composition measured as percentage muscle mass |
| Physical fitness | 3 and 6 months | Indirect exercise test on a tread-mill until exhaustion. Measured in oxygen uptake ml/min/kg. |
| Biologic disease modifying anti-rheumatic drugs 3 months | 3 months | Number of participants on biologic disease modifying anti-rheumatic drugs (bDMARD) at 3 months |
| Disease activity 6 months | 6 months | Number of participants in ankylosing spondylitis disease activity score (ASDAS) inactive (ASDAS \< 1.3) at 6 months |
| Proportion of participants using non-steroidal anti-inflammatory drugs | 3 and 6 months | Usage of non-steroidal anti-inflammatory drugs (NSAIDs) |
| Bath ankylosing spondylitis metrology index | 3 and 6 months | Physical function measured by Bath ankylosing spondylitis metrology index (BASMI). Range 0-10 where 0= no functional impairment 10=very significant impairment |
| Bath ankylosing spondylitis function index | 3 and 6 months | Physical function measured by Bath ankylosing spondylitis function index (BASFI). Scale range 0-10, where 0= no functional impairment 10=very significant impairment |
| Physiological effects of exercise on adipose tissue | 3 and 6 months | Effect of exercise on body composition measured as percentage adipose tissue |
| Ankylosing spondylitis Performance Index | 3 and 6 months | 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. |
Countries
Norway
Contacts
CONTACTSella A Provan, Professor
CONTACTBirgitte Nellemann, PhD
Outcome results
None listed