Study protocol for a feasibility randomised controlled trial of MOVE SMART—An intervention to increase physical activity, reduce sedentary behaviour and improve health outcomes in patients with psoriasis

Abstract

Patients with psoriasis are less physically active than age-matched controls, due to psoriasis-specific barriers; significantly limiting their ability to benefit from health-promoting levels of physical activity. We co-designed an exercise intervention, with patients, which in proof-of-concept studies, led to significantly improved psoriasis; reduced cardiovascular disease/metabolic syndrome risk and enhanced wellbeing/ psychosocial functioning. This suggested increased physical activity may improve health outcomes for those with psoriasis. However, individuals remained sedentary for prolonged periods, which also has a detrimental effect on health. We therefore developed a new intervention – MOVE SMART – to increase light-intensity physical activity and interrupt sedentary behaviour. This randomised controlled clinical trial (RCT) will assess the feasibility and acceptability of MOVE SMART. Utilising a decentralised, two-arm, trial design, people with Type 1 psoriasis with/without stable psoriatic arthritis, (n=60) will be recruited from across the UK, and randomised to intervention (MOVE SMART with “Standard Care”, n=30) or control (“Standard Care”, n=30). The intervention group will follow MOVE SMART for 12-weeks, followed by activities of their own choice during weeks 13–24. MOVE SMART will prompt 2-minutes of light-intensity physical activity, following 30-minutes of continuous sedentary behaviour, during daytime waking hours. The study comprises of three Workstreams. In Workstream-1 participants will use wearable devices to allow monitoring of physical behaviour and adherence to MOVE SMART. A blood pressure monitor and body weight scales will be posted to participants for use throughout the study and functional capacity will be measured by video-link. At baseline, week-12 and −24 all participants will complete self-assessment of the extent/impact of psoriasis and wellbeing. Capillary blood will be collected using home-sampling kits. In Workstream-2 acceptability of the intervention will be evaluated and the trial design will be finalised in Workstream-3. The study is registered at www.isrctn.com (ISRCTN 17400289).