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

NCT03893500 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2024-05-03

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2025-06-30
Completion
2025-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03893500 on ClinicalTrials.gov