©2022 Stanford Medicine
Utility of At-home Monitoring of Exercise Capacity by App-based 6-minute Walk Test
Not Recruiting
Trial ID: NCT03893500
Purpose
- 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
Stanford Investigator(s)
Vinicio de Jesus Perez MD
Associate Professor of Medicine (Pulmonary and Critical Care Medicine)
Eligibility
Inclusion Criteria:
- 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
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)
Intervention(s):
device: Home-based 6 minute walk test
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Alejandra Elizabeth Lopez