Utility of At-home Monitoring of Exercise Capacity by App-based 6-minute Walk Test
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Device: Home-based 6 minute walk test
- Registration Number
- NCT03893500
- Lead Sponsor
- Stanford University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 63
- 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).
- Do not meet exclusion criteria
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Initiating a new PAH medication Home-based 6 minute walk test Participants will start a new PAH medication Continuing previous PAH medication regimen Home-based 6 minute walk test Participants will continue the medication regimen that they were on prior to enrollment
- Primary Outcome Measures
Name Time Method Count of participants with an increase of >32 meters in 6MWD from baseline as a measure of time to response to therapy 12 weeks Hazard ratios will be calculated at two week intervals to evaluate for between group differences
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 12 weeks 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
App/watch recorded and in-clinic recorded six minute walk distance (6MWD) 12 weeks 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
- Secondary Outcome Measures
Name Time Method 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 CI will be calculated as (actual peak HR - resting HR)/(Age predicted peak HR \[220-age\] - resting HR). Hazard ratios will be calculated at two week intervals to evaluate for between group differences
Within the treatment arm, count of participants with an increase of >5% in chronotropic index (CI) from baseline when comparing medication responders vs non-responders 12 weeks Medication responders will have a ≥32m improvement in 6MWD at 12 weeks; non-responders will have \<32m improvement. Hazard ratios will be calculated at two week intervals to evaluate for between group differences
Count of participants with a decrease of >5bpm in resting HR from baseline as a measure of time to response to therapy 12 weeks Hazard ratios will be calculated at two week intervals to evaluate for between group differences
Within the treatment arm, count of participants with an increase of >5ms in heart rate variability (HRV) from baseline when comparing medication responders vs non-responders 12 weeks Medication responders will have a ≥32m improvement in 6MWD at 12 weeks; non-responders will have \<32m improvement. Hazard ratios will be calculated at two week intervals to evaluate for between group differences
Between group difference in 6MWD as a measure of response to the intervention 12 weeks A two-sample T-test will be performed on the delta change in 6MWD (week 12 - baseline / baseline) x100\]) between the treatment and control groups and a p-value will be calculated from this data.
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 HRV will be calculated as the standard deviation of R wave to R wave intervals (SDNN) over the 2 minute period following exercise. Hazard ratios will be calculated at two week intervals to evaluate for between group differences
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 Medication responders will have a ≥32m improvement in 6MWD at 12 weeks; non-responders will have \<32m improvement. Hazard ratios will be calculated at two week intervals to evaluate for between group differences
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 Medication responders will have a ≥32m improvement in 6MWD at 12 weeks; non-responders will have \<32m improvement. Hazard ratios will be calculated at two week intervals to evaluate for between group differences
Trial Locations
- Locations (1)
Stanford University
🇺🇸Stanford, California, United States