针对冠心病患者,有或无每周在线辅导的远程心脏康复中的可穿戴设备:随机对照试验

Wearable Devices in Remote Cardiac Rehabilitation With and Without Weekly Online Coaching for Patients With Coronary Artery Disease: Randomized Controlled Trial.

作者信息

Nishio Ryota, Dohi Tomotaka, Yokoyama Miho, Nakade Taisuke, Takahashi Norihito, Chikata Yuichi, Endo Hirohisa, Nishiyama Hiroki, Okai Iwao, Iwata Hiroshi, Okazaki Shinya, Miyauchi Katsumi, Daida Hiroyuki, Minamino Tohru

机构信息

Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan, 81 3 3813 3111, 81 3 5802 3946.

Department of Cardiovascular Medicine, Juntendo University Shizuoka Hospital, Izunokuni, Shizuoka, Japan.

出版信息

JMIR Mhealth Uhealth. 2025 May 12;13:e63797. doi: 10.2196/63797.

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.

摘要

背景

心脏康复(CR)在预防心血管疾病方面有效;然而,由于相关挑战,参与CR项目的人数仍然有限。可穿戴设备与实时监测的整合为提高对远程CR项目的依从性及其效果提供了一种潜在的解决方案。

目的

本研究旨在评估使用可穿戴设备和实时监测并结合或不结合在线指导(OLC)的远程CR项目对改善冠心病(CAD)患者运动能力的疗效。

方法

在这项随机、开放标签、单中心的III期试验性研究中,我们招募了50例CAD患者参与一个远程CR项目。在进行基线心肺运动试验(CPET)后,所有患者都被分配了一个基于CPET的家庭锻炼计划,并获得了一个配备实时监测系统(Recoval;SapplyM公司)的可穿戴设备(Fitbit Sense;Fitbit公司)。患者被随机分为接受OLC的干预组(n = 25)或对照可穿戴设备(CON;n = 25)组。主要结局指标是12周时峰值摄氧量(peak VO2)和无氧阈VO2(摄氧量)的变化。次要结局指标是CPET参数、日常活动、焦虑水平以及健康相关生活质量的变化。

结果

在OLC组(+1.6 mL/kg/min,P <.001;+1.0 mL/kg/min,P =.001)和CON组(+0.6 mL/kg/min,P =.008;+1.3 mL/kg/min,P =.002)中,从基线到12周,peak VO2和无氧阈VO2均显著增加,组间差异无统计学意义(P =.65和P =.90)。在干预的后半段,OLC组的每日行走距离和高活动时间与CON组相比显著增加(均P <.05)。两组间精神状态和健康相关生活质量评分无显著差异。未报告重大不良心脏事件。OLC组有1例患者因下肢肌肉拉伤退出。

结论

在为期12周的干预项目中,使用可穿戴设备和实时监测系统的远程CR显著改善了CAD患者的运动能力。在干预项目中增加定期的OLC进一步提高了身体活动水平,尤其是在高强度活动方面。未来有必要开展研究,在更多样化的人群中以及更长的干预期内验证这些发现,以优化远程CR项目的益处和安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2858/12088619/4087c27b8065/mhealth-v13-e63797-g001.jpg

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