Wearable Devices in Remote Cardiac Rehabilitation With and Without Weekly Online Coaching for Patients With Coronary Artery Disease: Randomized Controlled Trial
Ryota Nishio, Tomotaka Dohi, Miho Yokoyama, Taisuke Nakade, Norihito Takahashi, Yuichi Chikata, Hirohisa Endo, Hiroki Nishiyama, Iwao Okai, Hiroshi Iwata, Shinya Okazaki, Katsumi Miyauchi, Hiroyuki Daida, Tohru Minamino
Abstract
Background: Cardiac rehabilitation (CR) is effective in preventing cardiovascular diseases; however, participation in CR programs remains limited due to the associated challenges. The integration of wearable devices and real-time monitoring offers a potential solution to enhance adherence to remote CR programs and their outcomes. Objective: This study aimed to evaluate the efficacy of a remote CR program using wearable devices and real-time monitoring with or without online coaching (OLC) in improving exercise capacity in patients with coronary artery disease (CAD). Methods: We enrolled 50 patients with CAD in a remote CR program in this randomized, open-label, single-center pilot trial (phase III). After baseline cardiopulmonary exercise tests (CPETs), all patients were assigned a CPET-based home exercise program and were provided with a wearable device (Fitbit Sense; Fitbit, Inc) with a real-time monitoring system (Recoval; SapplyM, Inc). The patients were randomly assigned to an intervention group with OLC (n=25) or a control wearable device (CON; n=25) group. The primary outcomes were changes in peak oxygen consumption (peak VO2) and anaerobic threshold VO2 (oxygen consumption) at 12 weeks. The secondary outcomes were changes in CPET parameters, daily activity, anxiety levels, and health-related quality of life. Results: Peak VO2 and anaerobic threshold VO2 increased significantly from baseline to 12 weeks in the OLC (+1.6 mL/kg/min, P<.001; +1.0 mL/kg/min, P=.001) and CON (+0.6 mL/kg/min, P=.008; +1.3 mL/kg/min, P=.002) groups with no significant between-group differences (P=.65 and P=.90). In the latter half of the intervention, the daily distance and highly active time in the OLC group were significantly increased compared with those in the CON group (all P<.05). Mental status and health-related quality of life scores showed no significant differences between the groups. No major adverse cardiac events were reported. One patient in the OLC group dropped out due to lower limb muscle strain. Conclusions: Remote CR using wearable devices and a real-time monitoring system significantly improved exercise capacity in patients with CAD over a 12-week intervention program. The addition of regular OLC to the intervention program further enhanced the physical activity levels, particularly in high-intensity activities. Future studies are warranted to validate these findings in more diverse populations and over longer intervention periods to optimize the benefits and safety of remote CR programs.