AHA Scientific Sessions 2026 Abstract · Nov 2, 2026
Phase II Trial and Ongoing Confirmatory Phase III Trial of a Cardiac Rehabilitation Medical Device Program with Exercise-Intensity Optimization for Standing Exercise at the Anaerobic Threshold
By Terashima K, KONO Y, Kawai H et al.
Background: Cardiac rehabilitation (CR) improves prognosis in patients with cardiovascular disease (CVD), yet participation worldwide remains low because of the burden of in-person, center-based visits, falling to as low as 4-8% in Japan. To address this gap, we developed a CR medical device program that delivers home-based CR. Using a tablet device, the program guides standing aerobic exercise without requiring an ergometer and automatically optimizes exercise intensity in real time to maintain the anaerobic threshold (AT) level. Hypothesis: A home-based CR medical device program with real-time exercise-intensity optimization during standing exercise at the AT level safely improves exercise capacity in patients with CVD. Methods: This was a single-center, single-arm, prospective phase II clinical trial evaluating an unapproved medical device. Thirty patients with CVD eligible for CR were enrolled. Based on an exercise prescription derived from baseline cardiopulmonary exercise testing, participants performed unsupervised home-based aerobic exercise (1 hour per session, 3 times per week) for 5 months. During each session, the program automatically adjusted exercise intensity in real time according to the participant's entered Borg scale rating. Exercise and lifestyle guidance was provided online every other week by physicians, physical therapists, and other staff. The primary endpoint was the relative change in 6-minute walk distance (6MWD) at 5 months, analyzed with a one-sample t-test against μ=5%. Secondary endpoints included peak VO2 and safety. Results: Thirty patients with CVD (mean age 61.6±8.9 years; 76.7% male) were enrolled. Indications for CR were myocardial infarction in 63.3%, heart failure in 23.3%, and angina pectoris in 10.0%. All participants completed the program, with a median of 58 exercise sessions (IQR 28-78). 6MWD improved from 468.3±98.8 m to 542.6±70.3 m, with a mean relative change of 18.6% (95% CI 12.1-25.1; P<0.001 vs. μ=5%). Peak VO2 increased from 18.5±4.7 to 21.4±5.5 mL/min/kg (relative change 16.7%; 95% CI 12.2-21.2; P=0.030). No cardiovascular adverse events attributable to the program occurred during the trial. Conclusions: A home-based CR medical device program with real-time exercise-intensity optimization at the AT level achieved high adherence and a significant improvement in exercise capacity, together with a favorable safety profile, in patients with CVD. To confirm these findings, a large-scale, multicenter, randomized controlled phase III trial comparing the investigational device with conventional outpatient CR in patients eligible for CR is currently underway in Japan (jRCT2042260056), with an 84-day intervention period and 6MWD as the primary endpoint.