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

NCT03893500 | Active Not Recruiting 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 (3)

• App/watch recorded and in-clinic recorded six minute walk distance (6MWD)

  App/watch recorded and in-clinic recorded 6MWD will be compared by Bland Altman graph and will be considered interchangeable if the line of equality lands within the 95% confidence interval of the mean difference

  12 weeks

• Count of participants with an increase of >32 meters in 6MWD from baseline as a measure of time to response to therapy

  Hazard ratios will be calculated at two week intervals to evaluate for between group differences

  12 weeks

• Count of participants with an increase of >3bpm in heart rate recovery at one minute (HRR1) from baseline as a measure of time to response to therapy

  HRR1 is calculated as peak heart rate (pHR) - HR one minute into recovery period. Hazard ratios will be calculated at two week intervals to evaluate for between group differences

  12 weeks

Secondary Outcomes (8)

• Count of participants with a decrease of >5bpm in resting HR from baseline as a measure of time to response to therapy

  12 weeks

• Count of participants with an increase of >5ms in heart rate variability (HRV) from baseline as a measure of time to response to therapy

  12 weeks

• Count of participants with an increase of >5% in chronotropic index (CI) from baseline as a measure of time to response to therapy

  12 weeks

• Within the treatment arm, count of participants with an increase of >3bpm in heart rate recovery at one minute (HRR1) from baseline when comparing medication responders vs non-responders

  12 weeks

• Within the treatment arm, count of participants with a decrease of >5bpm in resting HR from baseline when comparing medication responders vs non-responders

  12 weeks

Study Arms (2)

Initiating a new PAH medication

EXPERIMENTAL

Participants will start a new PAH medication

Device: Home-based 6 minute walk test

Continuing previous PAH medication regimen

ACTIVE COMPARATOR

Participants will continue the medication regimen that they were on prior to enrollment

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.

Continuing previous PAH medication regimen; Initiating a new PAH medication

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• 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 30, 2025
• Study Completion: June 30, 2025
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)