A Digital Health Program Enhances Walking Capacity and Health Status in Symptomatic Peripheral Artery Disease

Abstract Background Intermittent claudication (IC) is the most common manifestation of peripheral artery disease (PAD), an atherosclerotic condition associated with high cardiovascular morbidity and mortality. Management targets cardiovascular risk reduction and limb function, but effective non-invasive treatments for limb symptoms remain limited. Objective To evaluate whether a 12-week multimodal smartphone-based digital health program improves walking capacity and symptoms in patients with IC. Design Prospective, multicentre randomized controlled trial. Methods The IPAD trial compared standard care alone with standard care plus a 12-week digital health intervention focused on lifestyle modification and physical activity, incorporating behavioural change techniques and gamification. The primary observer-blinded endpoint was maximum walking distance (MWD) during a six-minute walk test (6MWT), contextualized against minimal clinically important difference (MCID) thresholds. Secondary endpoints included pain-free 6MWT distance and health-related quality of life (HRQoL). Results Over 21 months, 155 patients were randomized 1:1. Mean (SD) age was 71.8 (7.6) years. Compared with controls, the intervention group showed greater improvement in MWD (+21.44 m; 95% CI 6.00–36.87; p=0.007), exceeding the predefined 12-m MCID at the group level, and in pain-free walking distance (+32.95 m; 95% CI 0.68–65.23; p=0.045). The relative risk of achieving an individual 12-m MCID did not differ between groups (RR 1.27; 95% CI 0.91–1.76; p=0.162). Exploratory analysis using a 20.1-m MCID showed a higher proportion of patients achieving the MCID in the intervention group (RR 1.97; 95% CI 1.16–3.34; p=0.012). HRQoL improved nominally, with a between-group benefit on the EQ-5D visual analogue scale (+6.29 points; 95% CI 1.33–11.20; p=0.013). Conclusion The digital-health program resulted in a clinically meaningful improvement in walking capacity in PAD patients with IC.