Radboud University Medical Center, Donders Institute for Brain, Cognition and Behavior, Department of Neurology, Center of Expertise for Parkinson & Movement Disorders, Nijmegen, Netherlands.
Verily Life Sciences, South San Fransisco, CA, United States.
JMIR Res Protoc. 2024 May 7;13:e55452. doi: 10.2196/55452.
Physical capacity and physical activity are important aspects of physical functioning and quality of life in people with a chronic disease such as Parkinson disease (PD) or chronic obstructive pulmonary disease (COPD). Both physical capacity and physical activity are currently measured in the clinic using standardized questionnaires and tests, such as the 6-minute walk test (6MWT) and the Timed Up and Go test (TUG). However, relying only on in-clinic tests is suboptimal since they offer limited information on how a person functions in daily life and how functioning fluctuates throughout the day. Wearable sensor technology may offer a solution that enables us to better understand true physical functioning in daily life.
We aim to study whether device-assisted versions of 6MWT and TUG, such that the tests can be performed independently at home using a smartwatch, is a valid and reliable way to measure the performance compared to a supervised, in-clinic test.
This is a decentralized, prospective, observational study including 100 people with PD and 100 with COPD. The inclusion criteria are broad: age ≥18 years, able to walk independently, and no co-occurrence of PD and COPD. Participants are followed for 15 weeks with 4 in-clinic visits, once every 5 weeks. Outcomes include several walking tests, cognitive tests, and disease-specific questionnaires accompanied by data collection using wearable devices (the Verily Study Watch and Modus StepWatch). Additionally, during the last 10 weeks of this study, participants will follow an aerobic exercise training program aiming to increase physical capacity, creating the opportunity to study the responsiveness of the remote 6MWT.
In total, 89 people with PD and 65 people with COPD were included in this study. Data analysis will start in April 2024.
The results of this study will provide information on the measurement properties of the device-assisted 6MWT and TUG in the clinic and at home. When reliable and valid, this can contribute to a better understanding of a person's physical capacity in real life, which makes it possible to personalize treatment options.
ClinicalTrials.gov NCT05756075; https://clinicaltrials.gov/study/NCT05756075.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/55452.
身体能力和身体活动是患有慢性疾病（如帕金森病或慢性阻塞性肺疾病）的人身体功能和生活质量的重要方面。目前，身体能力和身体活动都是在诊所使用标准化问卷和测试来测量的，例如 6 分钟步行测试（6MWT）和计时起立行走测试（TUG）。然而，仅依赖于诊所测试是不理想的，因为它们提供的信息有限，无法了解一个人在日常生活中的功能以及功能在一天中如何波动。可穿戴传感器技术可能提供一种解决方案，可以使我们更好地了解日常生活中的真实身体功能。
我们旨在研究使用智能手表在家中独立进行设备辅助的 6MWT 和 TUG 测试是否是一种有效的、可靠的方法，可以与监督下的诊所测试相比来测量性能。
这是一项去中心化、前瞻性、观察性研究，包括 100 名帕金森病患者和 100 名慢性阻塞性肺疾病患者。纳入标准很广泛：年龄≥18 岁，能够独立行走，且没有帕金森病和慢性阻塞性肺疾病同时发生。参与者随访 15 周，每 5 周进行 4 次诊所访问。结果包括几项步行测试、认知测试和疾病特异性问卷，并伴有可穿戴设备（Verily Study Watch 和 Modus StepWatch）的数据收集。此外，在这项研究的最后 10 周，参与者将参加一项有氧运动训练计划，旨在提高身体能力，为研究远程 6MWT 的反应性提供机会。
共有 89 名帕金森病患者和 65 名慢性阻塞性肺疾病患者纳入本研究。数据分析将于 2024 年 4 月开始。
这项研究的结果将提供有关在诊所和家中进行设备辅助 6MWT 和 TUG 测量特性的信息。当可靠和有效时，这有助于更好地了解一个人在现实生活中的身体能力，从而可以个性化治疗方案。
ClinicalTrials.gov NCT05756075；https://clinicaltrials.gov/study/NCT05756075。
国际注册报告标识符（IRRID）：DERR1-10.2196/55452。
