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ACTIVE NOT RECRUITING
NCT03893500
NA

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

Sponsor: Stanford University

View on ClinicalTrials.gov

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 responders when compared to treatment non-responders.

Official title: Utility of Device and App-based Mobile Health Monitoring as a Tool for Evaluation of Clinical Response to Therapies in Pulmonary Arterial Hypertension

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

63

Start Date

2020-07-01

Completion Date

2025-06-30

Last Updated

2024-05-03

Healthy Volunteers

No

Interventions

DEVICE

Home-based 6 minute walk test

Participants will receive a loaner Apple Watch with the Walk.Talk.Track. (WTT, produced by PHaware) app downloaded. Participants will perform a daily 6MWT at home using the Apple Watch and WTT app. They will undergo a history and physical, blood draw, echocardiogram and in-clinic 6MWT at the baseline and 12-week follow up visit.

Locations (1)

Stanford University

Stanford, California, United States