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基于数字疗法的肺癌幸存者心脏肿瘤康复:随机对照试验

Digital Therapeutics-Based Cardio-Oncology Rehabilitation for Lung Cancer Survivors: Randomized Controlled Trial.

作者信息

Li Guangqi, Zhou Xueyan, Deng Junyue, Wang Jiao, Ai Ping, Zeng Jingyuan, Ma Xuelei, Liao Hu

机构信息

Department of Biotherapy, Cancer Center and State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, China.

West China School of Medicine, Sichuan University, Chengdu, China.

出版信息

JMIR Mhealth Uhealth. 2025 Feb 25;13:e60115. doi: 10.2196/60115.

Abstract

BACKGROUND

Lung cancer ranks as the leading cause of cancer-related deaths. For lung cancer survivors, cardiopulmonary fitness is a strong independent predictor of survival, while surgical interventions impact both cardiovascular and pulmonary function. Home-based cardiac telerehabilitation through wearable devices and mobile apps is a substitution for traditional, center-based rehabilitation with equal efficacy and a higher completion rate. However, it has not been widely used in clinical practice.

OBJECTIVE

The objective of this study was to broaden the use of digital health care in the cardiopulmonary rehabilitation of lung cancer survivors and to assess its impact on cardiopulmonary fitness and quality of life (QOL).

METHODS

Early-stage nonsmall cell lung cancer survivors aged 18-70 years were included. All the participants received surgery 1-2 months before enrollment and did not require further antitumor therapy. Participants were randomly assigned to receive cardiac telerehabilitation or usual care for 5 months. Artificial intelligence-driven exercise prescription with a video guide and real-time heart rate (HR) monitoring was generated based on cardiopulmonary exercise testing. Aerobic exercise combining elastic band-based resistance exercises were recommended with a frequency of 3-5 d/wk and a duration of 90-150 min/wk. The effective exercise duration was recorded when patients' HR reached the target zone (HR + [HR - HR] × [≈40%-60%]), representing the duration under the target intensity. The prescription used a gradual progression in duration and action intensity based on the exercise data and feedback. Outcome measurements included cardiopulmonary fitness; lung function; cardiac function; tumor marker; safety; compliance; and scales assessing symptoms, psychology, sleep, fatigue, and QOL.

RESULTS

A total of 40 (85%) out of 47 patients finished the trial. The average prescription compliance rate of patients in the telerehabilitation group reached 101.2%, with an average exercise duration of 151.4 min/wk and an average effective exercise duration of 92.3 min/wk. The cardiac telerehabilitation was associated with higher improvement of maximal oxygen uptake peak (3.66, SD 3.23 mL/Kg/min vs 1.09, SD 3.23 mL/Kg/min; P=.02) and global health status or QOL (16.25, SD 23.02 vs 1.04, SD 13.90; P=.03) compared with usual care. Better alleviation of affective interference (-0.88, SD 1.50 vs 0.21, SD 1.22; P=.048), fatigue (-8.89, SD 15.96 vs 1.39, SD 12.09; P=.02), anxiety (-0.31, SD 0.44 vs -0.05, SD 0.29; P=.048), and daytime dysfunction (-0.55, SD 0.69 vs 0.00, SD 0.52; P=.02) was also observed in the telerehabilitation group. No exercise-related adverse events were identified during the intervention period.

CONCLUSIONS

The 5-month, digital therapeutics-based telerehabilitation improved cardiorespiratory fitness in lung cancer survivors with good compliance and safety. Patients receiving telerehabilitation also reported improved QOL with reduced levels of fatigue, anxiety, and daytime dysfunction.

TRIAL REGISTRATION

Chinese Clinical Trial Registry ChiCTR2200064000; https://www.chictr.org.cn/showproj.html?proj=180594.

摘要

背景

肺癌是癌症相关死亡的主要原因。对于肺癌幸存者而言,心肺适能是生存的有力独立预测因素,而手术干预会影响心血管和肺功能。通过可穿戴设备和移动应用程序进行的家庭心脏远程康复可替代传统的基于中心的康复,疗效相同且完成率更高。然而,它尚未在临床实践中广泛应用。

目的

本研究的目的是扩大数字医疗在肺癌幸存者心肺康复中的应用,并评估其对心肺适能和生活质量(QOL)的影响。

方法

纳入年龄在18 - 70岁的早期非小细胞肺癌幸存者。所有参与者在入组前1 - 2个月接受了手术,且不需要进一步的抗肿瘤治疗。参与者被随机分配接受心脏远程康复或常规护理,为期5个月。基于心肺运动测试生成带有视频指导和实时心率(HR)监测的人工智能驱动运动处方。建议进行结合弹力带抗阻运动的有氧运动,频率为每周3 - 5天,持续时间为每周90 - 150分钟。当患者心率达到目标区域(心率 + [心率 - 静息心率] × [≈40% - 60%])时记录有效运动持续时间,即目标强度下的持续时间。该处方根据运动数据和反馈在持续时间和动作强度上逐步增加。结果测量包括心肺适能;肺功能;心功能;肿瘤标志物;安全性;依从性;以及评估症状、心理、睡眠、疲劳和生活质量的量表。

结果

47名患者中有40名(85%)完成了试验。远程康复组患者的平均处方依从率达到101.2%,平均运动持续时间为每周151.4分钟,平均有效运动持续时间为每周92.3分钟。与常规护理相比,心脏远程康复与更高的最大摄氧量峰值改善相关(3.66,标准差3.23 mL/Kg/分钟对1.09,标准差3.23 mL/Kg/分钟;P = 0.02)以及整体健康状况或生活质量改善相关(16.25,标准差23.02对1.04,标准差13.90;P = 0.03)。远程康复组在情感干扰(-0.88,标准差1.50对0.21,标准差1.22;P = 0.048)、疲劳(-8.89,标准差15.96对1.39,标准差12.09;P = 0.02)、焦虑(-0.31,标准差0.44对 -0.05,标准差0.29;P = 0.048)和日间功能障碍(-0.55,标准差0.69对0.00,标准差0.52;P = 0.02)方面也有更好的缓解。干预期间未发现与运动相关的不良事件。

结论

基于数字疗法的5个月远程康复改善了肺癌幸存者的心肺适能,具有良好的依从性和安全性。接受远程康复的患者还报告生活质量得到改善,疲劳、焦虑和日间功能障碍水平降低。

试验注册

中国临床试验注册中心ChiCTR2200064000;https://www.chictr.org.cn/showproj.html?proj=180594

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2e1/11897676/5d45008332d9/mhealth_v13i1e60115_fig1.jpg

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