BENITIONSClinical Trial Intelligence

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

N/A Completed NCT03893500

ConditionPulmonary Arterial Hypertension
PhaseN/A
SponsorStanford University
StatusCompleted
Enrollment63 participants
InterventionsHome-based 6 minute walk test
Start dateJul 1, 2020
Completion dateJun 1, 2024
Results postedJul 28, 2026

Summary

* 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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