Clinical efficacy of a digital therapeutic for cardiac rehabilitation : a multicenter randomized controlled trial

Objectives Cardiac rehabilitation (CR) is an evidence-based, multidisciplinary intervention that reduces mortality and improves functional recovery. Despite these benefits, participation rates remain suboptimal, largely due to limited accessibility and insufficient patient engagement inherent to traditional center-based CR models. Digital therapeutics, integrating mobile technologies, wearable sensors, and telemonitoring, have recently emerged as a promising strategy to overcome these barriers of center-based CR. This study aimed to evaluate the clinical efficacy of home-based CR supported by a novel digital therapeutic system. Design Patients with cardiovascular disease who were eligible for CR and had recently undergone revascularization or cardiac surgery were randomized to either the intervention or control group. The intervention group used a chest-worn Holter electrocardiogram device for heart-rate monitoring during exercise, along with a digital therapeutic software that provided personalized exercise prescriptions based on home-based evaluations and offered real-time monitoring and feedback through a mobile application. The control group received education to perform exercise independently without HR monitoring. All participants were instructed to perform high-intensity interval training (six cycles of 3-minute high and 3-minute low intensity) three times per week for 12 weeks. The primary outcome was peak oxygen uptake (peak VO2); secondary outcomes included quality of life, physical activity index, and depression score. Results 87 patients (42 intervention, 45 control) completed 3-month follow-up. Peak VO2 significantly increased in the intervention group (27.0 ± 5.0 to 29.2 ± 5.0 mL/kg/min, P < 0.001) but not in the control group (28.5 ± 5.1 to 29.1 ± 5.3, P = 0.245). Consistently, the intervention group exhibited a significantly greater improvement in peak VO2 compared to the control group (2.3 ± 2.7 vs 0.6 ± 3.3, P = 0.009). After adjustment for age, sex, and baseline peak VO2, the adjusted mean peak VO2 at 3 months was 30.0 (95% CI, 29.1–30.8) in the intervention group and 28.4 (95% CI, 27.6–29.3) in the control group (P = 0.015 by analysis of covariance). Regarding secondary outcomes, within-group analysis revealed a significant improvement in the Korean Activity Scale/Index in the intervention group (64.5 ± 15.0 to 68.0 ± 11.4, P = 0.043), whereas no meaningful change occurred in the control group. Conclusions Home-based CR supported by digital therapeutics which integrates real-time heart-rate monitoring, remote patient supervision, and individualized exercise prescription, resulted in a significant improvement in exercise capacity compared to conventional self-directed exercise. These findings underscore the potential of digital, home-based CR to enhance overall program effectiveness and extend access to patients who are unable to participate in traditional center-based rehabilitation.