Telehealth Exercise Training in Peripheral Arterial Disease - TEXT-PAD

A Multimodal Tele-health Behavioural Intervention in Patients With Peripheral Arterial Disease From Low Socio-economic Areas: a Feasibility and Pilot Randomized Controlled Trial With Embedded Process Evaluation

Peripheral arterial disease is a common, undertreated and under-researched issue. The vast majority of these patients often have multiple issues which can be improved with targeted behavioural change interventions. NICE has recommended that supervised exercise is the main stay of treatment for intermittent claudication (ischaemic muscle pain on walking due to blocked and narrowed arteries). However, in the vast majority of UK hospitals this isn't undertaken and with the issues around group-based sessions and repeated visits to hospitals this treatment option is not available with the coronavirus pandemic. We proposed a single centre randomised control trial in 60 patients with peripheral arterial disease attending the Freeman Hospital. Patients will be randomised to either an enhanced behavioural change intervention targeting multiple health behaviours vs a simple walking intervention. We will also be embedding focus groups to understand patients experience of the intervention and whether the intervention is feasible and acceptable allowing changes to be made to the program. The primary outcome will be to assess the feasibility and acceptability of the program. We will also be assessing multiple secondary outcomes including functional capacity, quality of life, sleep quality and smoking and alcohol reduction.

Patients will also receive specific advice to perform an unsupervised walking exercise according to NICE guideline.

Patients will undergo to weekly phone call/videoconference for 12 weeks and discuss the behaviour change. They also will undergo to home-based exercise training will be performed twice a week for 12 weeks via Zoom (up to 5 patients per session). Each session will be comprised of warm-up (10 min), the main part (15 to 20 min), and cooldown (5 to 10 min). The training aims to develop resistance, aerobic and functional capacity such as getting up, walking, pulling, pushing, throwing, transferring body weight or external loads. In addition, patients will be encouraged to increase their physical activity. Patients will be provided with a Fitbit device to monitor their step count and will be recommended to increase their previous week's average step count by 10%.

Feasibility will be determined by calculating the rate of patient screening, eligibility, recruitment, retention at 12 weeks and adherence to the intervention (number of sessions attended and completed)

Patient acceptability of the intervention and study experience more broadly will be determined through semi-structured qualitative 1-2-1 interviews and/or focus groups.

The 3-item Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) and self-reported smoking habits

Inclusion Criteria: Diagnosis of PAD confirmed by ankle-brachial index <0.90 in one or both limbs Age >= 40 years Able to walk distance >50m Live in an area deemed in lowest 30% of super output area from Office of National Statistics Exclusion Criteria: chronic limb threatening ischemia short claudication distance <50m severe heart disease (Grade III or IV, New York Heart Association) severe ischemic or haemorrhagic stroke or neurodegenerative diseases severe hypertension (systolic blood pressure of more than 180 mm Hg, and a diastolic blood pressure of more than 100 mm Hg) uncontrolled cardiac arrhythmias (unstable angina during the previous month and myocardial infarction during the previous month) a resting heart rate of more than 120 beats per minute has already undergone angioplasty, bypass or other surgical intervention for PAD other severe comorbid conditions preventing the ability to engage in physical activity, inability or unwillingness to undertake the commitments of the study