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智能手表设备对冠心病患者家庭心脏康复依从性的有效性:随机对照试验

Effectiveness of Smartwatch Device on Adherence to Home-Based Cardiac Rehabilitation in Patients With Coronary Heart Disease: Randomized Controlled Trial.

作者信息

Zhang Sisi, Wang Yuehui, Wu Jiahui, Ma Changsheng, Meng Xiaoping

机构信息

Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.

Department of Geriatrics, Jilin Geriatrics Clinical Research Center, The First Hospital of Jilin University, Changchun, China.

出版信息

JMIR Mhealth Uhealth. 2025 Sep 18;13:e70848. doi: 10.2196/70848.

DOI:10.2196/70848
PMID:40966536
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12445619/
Abstract

BACKGROUND

Digital technologies have the potential to overcome many of the limitations associated with traditional center-based cardiac rehabilitation (CBCR), such as limited accessibility, transportation barriers, and low adherence. In this context, home-based cardiac rehabilitation (HBCR) has emerged as a promising alternative. However, maintaining adherence and providing continuous supervision in remote settings remain a major challenge. Smartwatch-based interventions may offer a novel solution to support and monitor patients in HBCR programs, yet robust clinical evidence is still limited.

OBJECTIVE

This study was designed to investigate the effectiveness of a smartwatch-facilitated HCBR model in improving exercise adherence and health-related outcomes in patients with coronary heart disease (CHD), aiming to improve adherence and other outcomes related to the secondary prevention of cardiovascular disease.

METHODS

We conducted a prospective, single-center, randomized, parallel-controlled, non-blinded trial. Eligible participants were adults (≥18 years) with a confirmed diagnosis of CHD, recruited from a tertiary hospital in Jilin Province, China. Participants were randomly assigned in a 1:1 ratio to either the intervention group (smartwatch-facilitated HBCR) or the control group (standard HBCR) for a duration of 3 months. The intervention group received a comprehensive program delivered via a smartwatch, including real-time feedback, remote supervision, physical activity monitoring, and educational content. The control group received conventional HBCR without technological assistance. The primary outcome was adherence to the HBCR program, assessed using the Home-Based Cardiac Rehabilitation Exercise Adherence Scale. Secondary outcomes included cardiopulmonary function (peak VO₂ measured via cardiopulmonary exercise testing), anxiety (Generalized Anxiety Disorder-7), depression (Patient Health Questionnaire-9), and health-related quality of life (36-Item Short Form Survey, SF-36), evaluated at baseline and at 3 months.

RESULTS

Between January 1 and December 30, 2023, a total of 62 patients (mean [SD] age 59.93 [10.06] years; 40.4% women [25/62]) were enrolled and randomized to the intervention group (n=32) or control group (n=30). Baseline characteristics were well balanced between the groups. At 3 months, participants in the smartwatch group demonstrated significantly higher adherence scores compared to the control group (P<.01). Additionally, the smartwatch group showed significant improvements in peak VO₂ (P<.01), anxiety (GAD-7, P<.01), depression (PHQ-9, P<.01), and selected domains of SF-36 (P<.05). No serious adverse events related to the intervention were reported, and user engagement with the smartwatch platform was high throughout the study period.

CONCLUSIONS

This study demonstrates that a smartwatch-facilitated HBCR model is both feasible and effective in enhancing adherence and improving clinical outcomes among patients with CHD. These findings support the integration of wearable technology into routine HBCR and lay the groundwork for future large-scale, multicenter trials.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac5d/12445619/7a2c89719d7e/mhealth-v13-e70848-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac5d/12445619/2dfdd85d7058/mhealth-v13-e70848-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac5d/12445619/e4ad7f0ecec2/mhealth-v13-e70848-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac5d/12445619/7a2c89719d7e/mhealth-v13-e70848-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac5d/12445619/2dfdd85d7058/mhealth-v13-e70848-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac5d/12445619/e4ad7f0ecec2/mhealth-v13-e70848-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac5d/12445619/7a2c89719d7e/mhealth-v13-e70848-g003.jpg
摘要

背景

数字技术有潜力克服许多与传统的基于中心的心脏康复(CBCR)相关的局限性,如可及性有限、交通障碍和依从性低等。在此背景下,家庭心脏康复(HBCR)已成为一种有前景的替代方案。然而,在远程环境中维持依从性并提供持续监督仍然是一项重大挑战。基于智能手表的干预措施可能为支持和监测HBCR项目中的患者提供一种新的解决方案,但有力的临床证据仍然有限。

目的

本研究旨在调查一种由智能手表辅助的HBCR模式在改善冠心病(CHD)患者运动依从性和健康相关结局方面的有效性,旨在提高依从性及与心血管疾病二级预防相关的其他结局。

方法

我们进行了一项前瞻性、单中心、随机、平行对照、非盲试验。符合条件的参与者为确诊为CHD的成年人(≥18岁),从中国吉林省的一家三级医院招募。参与者以1:1的比例随机分配至干预组(智能手表辅助的HBCR)或对照组(标准HBCR),为期3个月。干预组通过智能手表接受一个综合项目,包括实时反馈、远程监督、身体活动监测和教育内容。对照组接受无技术辅助的传统HBCR。主要结局是对HBCR项目的依从性,使用家庭心脏康复运动依从性量表进行评估。次要结局包括心肺功能(通过心肺运动试验测量的峰值VO₂)、焦虑(广泛性焦虑障碍量表-7)、抑郁(患者健康问卷-9)以及健康相关生活质量(36项简短健康调查,SF-36),在基线和3个月时进行评估。

结果

在2023年1月1日至12月30日期间,共招募了62例患者(平均[标准差]年龄59.93[10.06]岁;40.4%为女性[25/62]),并随机分为干预组(n = 32)或对照组(n = 30)。两组之间的基线特征均衡良好。在3个月时,智能手表组的参与者与对照组相比,表现出显著更高的依从性得分(P <.01)。此外,智能手表组在峰值VO₂(P <.01)、焦虑(GAD-7,P <.01)、抑郁(PHQ-9,P <.01)以及SF-36的选定领域(P <.05)方面有显著改善。未报告与干预相关的严重不良事件,并且在整个研究期间用户对智能手表平台的参与度很高。

结论

本研究表明,一种由智能手表辅助的HBCR模式在提高CHD患者的依从性和改善临床结局方面既可行又有效。这些发现支持将可穿戴技术整合到常规HBCR中,并为未来的大规模、多中心试验奠定了基础。

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