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

NCT03893500 | Completed Results FDA Device

• 2 other identifiers: SU-DynAMITEIRB-48742
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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

Pulmonary Arterial Hypertension

Keywords

Six minute walk test; Six minute walk distance; Heart rate recovery; Mobile health

Outcome Measures

Primary Outcomes (1)

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

  Participants will be asked to walk as far as possible along a corridor for a period of six minutes.

  12 weeks

Secondary Outcomes (1)

• App/Watch Recorded In-clinic Steps

  12 weeks

Study Arms (1)

Initiating an apple Watch

EXPERIMENTAL

Participants will start a new PAH medication

Device: Home-based 6 minute walk test

Interventions

Home-based 6 minute walk test DEVICE

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.

Initiating an apple Watch

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of WHO Group I Pulmonary Arterial Hypertension (PAH) (Idiopathic (I)PAH, Heritable PAH (including Hereditary Hemorrhagic Telangiectasia), Associated (A)PAH (including collagen vascular disorders, drugs+toxins exposure, congenital heart disease, and portopulmonary disease).

You may not qualify if:

• Pulmonary Hypertension due to left heart disease (PH-LHD, WHO group 2), Pulmonary hypertension due to chronic lung disease (PH-CLD, WHO group 3), Chronic thrombo-embolic pulmonary hypertension (CTEPH, WHO group 4), pulmonary hypertension with unclear and/or multi-factorial mechanisms (WHO goup 5)
• Inability to perform a 6 minute walk test (6MWT)

Sponsors & Collaborators

• Stanford University: lead
• PHaware: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (17)

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Related Links

• ATS guidelines for the 6 minute walk test

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Walk Test

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Exercise Test; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Roham Zamanian, MD
• Organization: Stanford University

roham.zamanian@stanford.edu

6507255495

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 28, 2019
• Study Start: July 1, 2020
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 28, 2026
• Results First Posted: July 28, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)