Bayer Vital GmbH, Leverkusen, Germany.
Department of Internal Medicine, Justus-Liebig-University Giessen, Universities of Giessen and Marburg Lung Center, Member of the German Center for Lung Research, Giessen, Germany.
J Med Internet Res. 2021 Oct 8;23(10):e25163. doi: 10.2196/25163.
Pulmonary arterial hypertension restricts the ability of patients to perform routine physical activities. As part of pulmonary arterial hypertension treatment, inhaled iloprost can be administered via a nebulizer that tracks inhalation behavior. Pulmonary arterial hypertension treatment is guided by intermittent clinical measurements, such as 6-minute walk distance, assessed during regular physician visits. Continuous digital monitoring of physical activity may facilitate more complete assessment of the impact of pulmonary arterial hypertension on daily life. Physical activity tracking with a wearable has not yet been assessed with simultaneous tracking of pulmonary arterial hypertension medication intake.
We aimed to digitally track the physical parameters of patients with pulmonary arterial hypertension who were starting treatment with iloprost using a Breelib nebulizer. The primary objective was to investigate correlations between changes in digital physical activity measures and changes in traditional clinical measures and health-related quality of life over 3 months. Secondary objectives were to evaluate inhalation behavior, adverse events, and changes in heart rate and sleep quality.
We conducted a prospective, multicenter observational study of adults with pulmonary arterial hypertension in World Health Organization functional class III who were adding inhaled iloprost to existing pulmonary arterial hypertension therapy. Daily distance walked, step count, number of standing-up events, heart rate, and 6-minute walk distance were digitally captured using smartwatch (Apple Watch Series 2) and smartphone (iPhone 6S) apps during a 3-month observation period (which began when iloprost treatment began). Before and at the end of the observation period (within 2 weeks), we also evaluated 6-minute walk distance, Borg dyspnea, functional class, B-type natriuretic peptide (or N-terminal pro-B-type natriuretic peptide) levels, health-related quality of life (EQ-5D questionnaire), and sleep quality (Pittsburgh Sleep Quality Index).
Of 31 patients, 18 were included in the full analysis (observation period: median 91.5 days, IQR 88.0 to 92.0). Changes from baseline in traditional and digital 6-minute walk distance were moderately correlated (r=0.57). Physical activity (daily distance walked: median 0.4 km, IQR -0.2 to 1.9; daily step count: median 591, IQR -509 to 2413) and clinical measures (traditional 6-minute walk distance: median 26 m, IQR 0 to 40) changed concordantly from baseline to the end of the observation period. Health-related quality of life showed little change. Total sleep score and resting heart rate slightly decreased. Distance walked and step count showed short-term increases after each iloprost inhalation. No new safety signals were identified (safety analysis set: n=30).
Our results suggest that despite challenges, parallel monitoring of physical activity, heart rate, and iloprost inhalation is feasible in patients with pulmonary arterial hypertension and may complement traditional measures in guiding treatment; however, the sample size of this study limits generalizability.
ClinicalTrials.gov NCT03293407; https://clinicaltrials.gov/ct2/show/NCT03293407.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/12144.
肺动脉高压限制了患者进行日常体力活动的能力。作为肺动脉高压治疗的一部分，可通过吸入 iloprost 的雾化器进行吸入 iloprost 治疗，该雾化器可跟踪吸入行为。肺动脉高压治疗由间歇性临床测量指标指导，如 6 分钟步行距离，在定期医生就诊期间进行评估。对体力活动的连续数字监测可能有助于更全面地评估肺动脉高压对日常生活的影响。带有可穿戴设备的体力活动跟踪尚未与肺动脉高压药物摄入的同时跟踪进行评估。
我们旨在使用 Breelib 雾化器对开始使用 iloprost 治疗的肺动脉高压患者的身体参数进行数字跟踪。主要目的是研究 3 个月内数字体力活动测量值的变化与传统临床测量值和健康相关生活质量变化之间的相关性。次要目的是评估吸入行为、不良事件以及心率和睡眠质量的变化。
我们进行了一项前瞻性、多中心、观察性研究，纳入了世界卫生组织功能分级为 III 级的肺动脉高压成年患者，这些患者正在添加吸入 iloprost 治疗。在 3 个月的观察期内（从 iloprost 治疗开始时开始），使用智能手表（Apple Watch Series 2）和智能手机（iPhone 6S）应用程序对日常步行距离、步数、起坐次数、心率和 6 分钟步行距离进行数字采集。在观察期开始前和结束时（在 2 周内），我们还评估了 6 分钟步行距离、Borg 呼吸困难、功能分级、B 型利钠肽（或 N 末端 B 型利钠肽）水平、健康相关生活质量（EQ-5D 问卷）和睡眠质量（匹兹堡睡眠质量指数）。
在 31 名患者中，18 名患者纳入了全分析集（观察期：中位数 91.5 天，IQR 88.0 至 92.0）。从基线到观察期结束，传统和数字 6 分钟步行距离的变化呈中度相关（r=0.57）。体力活动（日常步行距离：中位数 0.4 公里，IQR -0.2 至 1.9；日常步数：中位数 591，IQR -509 至 2413）和临床测量值（传统 6 分钟步行距离：中位数 26 米，IQR 0 至 40）从基线到观察期结束均呈一致变化。健康相关生活质量几乎没有变化。总睡眠评分和静息心率略有下降。每次吸入 iloprost 后，步行距离和步数均出现短期增加。未发现新的安全信号（安全性分析集：n=30）。
尽管存在挑战，但对肺动脉高压患者的体力活动、心率和 iloprost 吸入进行平行监测是可行的，可能有助于指导治疗；然而，这项研究的样本量限制了其普遍性。
ClinicalTrials.gov NCT03293407；https://clinicaltrials.gov/ct2/show/NCT03293407。
国际注册报告标识符（IRRID）：RR2-10.2196/12144。
