A study to determine the design and feasibility of a randomised controlled clinical trial of MOVE SMART - an intervention to increase physical activity, reduce sedentary behaviour and improve health outcomes in patients with psoriasis.

Research question Does a novel physical behaviour intervention (developed with patients) have clinical utility in the management of psoriasis?

Background We previously identified that patients with psoriasis are less physically active compared to age-matched controls, due to psoriasis-specific barriers.

As this significantly limits their ability to benefit from health-promoting levels of physical activity we co-designed an exercise intervention, with patients, observing in a proof-of-concept study significantly: improved psoriasis control; reduced cardiovascular disease/metabolic syndrome risk and enhanced wellbeing/psychosocial functioning.

This suggested that physical activity could constitute a promising therapeutic intervention for psoriasis.

However, individuals remained sedentary for prolonged periods of time, which has a detrimental effect on health independent of the amount of physical activity undertaken.

We therefore developed a new intervention, with lived-experience contributors, designed to i) increase light-intensity physical activity, ii) reduce overall sedentary time, and iii) interrupt bouts of prolonged (≥30-minutes) sedentary behaviour.

Aims and objectives Our aim is to assess the feasibility and acceptability of a randomised controlled clinical trial (RCT) of a novel, low-cost, physical behaviour intervention - MOVE SMART.

Objectives will establish the: -feasibility of the research processes and delivery of the intervention -acceptability of the intervention -design and research outcomes for the subsequent multi-centre RCT Methods Design: decentralised, two-arm, randomised controlled feasibility trial, co-designed with lived experience contributors.

Population: Type 1 chronic plaque psoriasis (disease onset before age 40-years) with/without stable psoriatic arthritis, (n=60). Recruitment: from across the UK supported by the Psoriasis Association and the UK Dermatology Clinical Trials Network. Intervention: MOVE SMART with “Standard Care” (n=30).

Control: “Standard Care” (n=30), which does NOT include advice on physical behaviour.

In this 24-week study, 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. In Workstream [1] we will use wearable devices to monitor 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 we will measure functional capacity by video-link.

At baseline, week-12 and -24 all participants will complete simple self-assessment of the extent/impact of their psoriasis, wellbeing and we will collect capillary blood using home-sampling kits.

In Workstream [2] we will evaluate the acceptability of the intervention and trial design before finalising this in Workstream [3].

Timelines for delivery Study duration of 24 months: 6 months set-up; 6 months recruitment; 6 months follow-up and RCT design, 6 months data collection, analysis, reporting.

Impact and dissemination This study addresses the MOST important priorities identified by the Psoriasis Priority Setting Partnership (PSP) and the Psoriatic Arthritis PSP and will also determine whether progression to a definitive multi-centre RCT of MOVE SMART (a low-cost intervention, potentially beneficial across several critical health outcomes for patients with psoriasis) is feasible.

We will disseminate results through journals, conferences, co-designed materials, and social media for patients, public and healthcare professionals.