Telehealth Exercise Training in Peripheral Arterial Disease (TEXTPAD) study: A pilot randomised controlled trial in socioeconomically disadvantaged populations

Abstract

Background Peripheral arterial disease (PAD) is a common condition among older adults, particularly those in socioeconomically disadvantaged populations. Supervised exercise is a key treatment for PAD-related claudication, but access to such programs is limited, especially following the COVID-19 pandemic. Telehealth interventions offer a promising alternative, but their feasibility and effectiveness in these populations remain unclear. Objective This study aimed to assess the feasibility of a home-based telehealth intervention combining exercise and behaviour change counselling for patients with PAD from socioeconomically deprived areas of the UK. Methods A pilot randomised controlled trial (RCT) was conducted with PAD patients (n = 36) recruited from the Vascular Unit of Freeman Hospital, Newcastle upon Tyne, UK. Participants were randomly assigned to either a telehealth intervention group (n = 19) or a control group (n = 17). The intervention consisted of weekly phone-based behaviour change counselling and twice-weekly virtual supervised exercise sessions for 12 weeks. Primary feasibility outcomes included recruitment, retention, and adherence. Secondary outcomes assessed functional capacity, quality of life, smoking and alcohol use, and dietary habits. Results Of the 102 eligible patients, 36 were recruited, falling short of the target recruitment goal of 60 participants. The intervention group attended a median of 20 supervised exercise sessions (max 24) and 11 sessions with the health improvement practitioner (max 12). Exploratory analyses suggested improvements in subjective functional capacity, as measured by walking speed and stair-climbing ability (P < 0.01), and quality of life (P < 0.01) in the intervention group compared to the control group. A 50% smoking cessation rate was observed among baseline smokers in the intervention group, while no changes were observed in the control group. No significant differences were observed between groups in objective functional capacity (as measured by the 6-minute walk test), alcohol intake, or dietary quality. Conclusion This digitally delivered, home-based telehealth intervention was feasible for PAD patients in socioeconomically disadvantaged areas. Exploratory findings suggest potential benefits in subjective function capacity and health behaviours; however, the study was not powered to evaluate effectiveness, and findings should be interpreted with caution. These data support the suitability of outcome measures and provide essential insights for designing a fully powered definitive trial to evaluate long-term clinical outcomes.