BENITIONSClinical Trial Intelligence

Utility of At-home Monitoring of Exercise Capacity by App-based 6-minute Walk Test

不适用 已完成 NCT03893500

适应症Pulmonary Arterial Hypertension
分期不适用
申办方Stanford University
状态已完成
受试者人数63 人
干预(药物)Home-based 6 minute walk test
开始日期2020年7月1日
完成日期2024年6月1日
结果公布日2026年7月28日

摘要

* Evaluate for accuracy and reproducibility of data collected via the participant-operated Walk.Talk.Track. (WTT) app combined with Apple Watch during in-clinic, technician proctored 6MWT's. * Determine whether the WTT app on the Apple Watch can accurately collect information on distance traveled and heart rate (HR) during in-clinic 6MWT run by American Thoracic Society (ATS) guidelines * Determine whether participants can operate the WTT app and Apple Watch effectively to gather accurate data in a monitored and home-based setting * Prospectively monitor for changes in WTT app recorded 6MWT results following initiation of therapy in a treatment naïve cohort of PAH participants * Evaluate whether changes from baseline in 6 minute walk distance (6MWD) and heart rate recovery at one minute (HRR1) as well as other variables that have been associated with disease severity in PAH and left-sided heart disease (resting HR, heart rate variability \[HRV\], chronotropic index \[CI\]) can be identified before the 12-week follow up when comparing the treatment arm and the control arm * Evaluate whether changes from baseline in the HRR1, resting HR, HRV and/or CI are more evident in treatment re

App/Watch Recorded In-clinic Six Minute Walk Distance (6MWD)

12 weeks · meters

All Study Patients473 ± 32 meters
Mean Difference (Net)1

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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。