Comparison of in-clinic assessment of 6MWT by conventional method and using wearable sensors for patients with ATTR-CM.

IF 1.6 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS

Future cardiology Pub Date : 2025-02-01 Epub Date: 2025-01-29 DOI:10.1080/14796678.2025.2457881

Prem Soman, Michel G Khouri, Daniel Lenihan, Alex Reyentovich, Brett W Sperry, Kristen Sowalsky, Yun Bai, Jing Du, Leonid Katz, Suresh Siddhanti, Jonathan C Fox

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Abstract

Introduction: The 6-minute walk test (6MWT) is used to assess submaximal exercise capacity in clinical trials. Conducting the 6MWT can be challenging when patients cannot visit the clinic due to physical/travel limitations. This pilot study assessed the feasibility of conducting the 6MWT using wearable sensors for patients with transthyretin amyloid cardiomyopathy.

Methods: Participants were enrolled in the phase 3 ATTRibute-CM trial. Sensors were positioned on patients' feet and lower back during the 6MWT. The 6-minute walk distance (6MWD) was compared with the distance measured by a trained observer during a concurrent conventional test. Pearson and concordance correlation coefficients were estimated.

Results: Twelve participants from five centers participated; 11 had evaluable data. Mean 6MWD was 330.3 m (conventional method) and 335.1 m (wearable sensors); mean difference (SD) was 4.7 m (10.95). Pearson and concordance correlation coefficients for 6MWD were 0.998 (95% CI: 0.992-0.999) and 0.997 (95% CI: 0.991-0.999), respectively.

Conclusions: The 6MWD measured using wearable sensors and by the conventional method were closely correlated. Conducting the 6MWT with wearable sensors may be feasible and as reliable as the conventional method in a monitored clinic setting. Whether at-home 6MWD measured by wearable sensors correlates with in-clinic monitoring deserves further study.

Clinical trial registration: ClinicalTrials.gov identifier is NCT03860935.

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常规方法与可穿戴传感器对atr - cm患者临床6MWT评估的比较

在临床试验中，6分钟步行试验（6MWT）用于评估亚极限运动能力。当患者由于身体/旅行限制而无法前往诊所时，进行6MWT可能具有挑战性。本初步研究评估了使用可穿戴传感器对转甲状腺蛋白淀粉样心肌病患者进行6MWT的可行性。方法：参与者被纳入3期ATTRibute-CM试验。在6MWT期间，传感器被放置在患者的足部和下背部。将6分钟步行距离（6MWD）与训练有素的观察者在同期常规测试中测量的距离进行比较。估计Pearson和concordance相关系数。结果：来自5个中心的12名受试者参与；11个国家有可评价的数据。平均6MWD为330.3 m（常规方法）和335.1 m（可穿戴传感器）；平均差异（SD）为4.7 m（10.95）。6MWD的Pearson和一致性相关系数分别为0.998 （95% CI: 0.992-0.999）和0.997 （95% CI: 0.991-0.999）。结论：可穿戴传感器测得的6MWD与常规方法测得的6MWD密切相关。使用可穿戴传感器进行6MWT可能是可行的，并且在监测的诊所环境中与传统方法一样可靠。可穿戴传感器测量的家庭6MWD是否与临床监测相关，值得进一步研究。临床试验注册：ClinicalTrials.gov识别码为NCT03860935。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Future cardiology CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

2.80

自引率

5.90%

发文量

期刊介绍： Research advances have contributed to improved outcomes across all specialties, but the rate of advancement in cardiology has been exceptional. Concurrently, the population of patients with cardiac conditions continues to grow and greater public awareness has increased patients" expectations of new drugs and devices. Future Cardiology (ISSN 1479-6678) reflects this new era of cardiology and highlights the new molecular approach to advancing cardiovascular therapy. Coverage will also reflect the major technological advances in bioengineering in cardiology in terms of advanced and robust devices, miniaturization, imaging, system modeling and information management issues.