Design A single centre, pilot, randomised controlled trial at Mid and South Essex Hospitals Foundation Trust. The study is unfunded and sponsored by Mid and South Essex Hospitals National Health Service Trust.~Sample size This is a pilot randomised controlled trial to generate a sample size calculation for a larger trial.~Based on the feasibility data from RESET1 and the published results of supervised exercise, the expected benefit of remotely supervised exercise is about 180 metres extra walking distance, with a standard deviation of 150m in both groups.~With alpha=0.05 (5% false positive rate) and beta=0.1 (90% power), 16 patients in each arm are required to demonstrate a mean difference in the primary endpoint of 180 metres, using a 2 sided t-test (MedCalc statistical software, Belgium).~The sample size will be 20+20 patients from Mid and South Essex Trust vascular outpatient clinics.~Follow up There will be 3 assessment visits: baseline, 3 months and 6 months performed with a study clinician.~The primary endpoint will be measured blind to treatment allocation by asking the patient to walk along a flat, hospital corridor until they need to stop due to leg pain. This will be measured at 0, 3 and 6 months.~The secondary endpoint will be through patient questionnaires and scored by an independent observer at baseline, 3 and 6 months.~Ankle-brachial pressure index will be measured by an independent vascular scientist at the start and end of the study.~Patient satisfaction will be measured at 3 months using a self-reported questionnaire.~Adherence to exercise will be measured through submission of walking logs at 1, 2 and 3 months.
Supervised exercise for intermittent claudication is a first line therapy for peripheral arterial disease, as recommended by the National Institute for Health and Clinical Excellence and the European Society for Vascular Surgery. However 2/3 of British trusts cannot implement this due to gym availability, costs, travel time and the requirement for social distancing.~During the COVID-19 lockdown the investigators successfully performed a feasibility study for remotely supervised exercise using an electronic walking log and fortnightly video calls with a physiotherapist.~RESET2 aims to compare the benefits of and adherence to remotely supervised exercise with self-directed exercise to absolute walking distance.