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 |
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| 分期 | 不适用 |
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| 申办方 | Stanford University |
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| 状态 | 已完成 |
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| 受试者人数 | 63 人 |
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| 干预(药物) | Home-based 6 minute walk test |
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| 开始日期 | 2020年7月1日 |
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| 完成日期 | 2024年6月1日 |
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| 结果公布日 | 2026年7月28日 |
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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 Patients | 473 ± 32 meters |
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