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Digital Assessment of Real-World Walking Activity in Pulmonary Hypertension: A Prospective Multicenter Trial
Sponsor: Simon Jäger
Summary
The goal of this observational study is to validate digital mobility outcomes for monitoring the treatment and disease progression in adult patients with pulmonary hypertension. The main question it aims to answer is: -Do digital mobility outcomes (measured digital endpoints characterizing walking behavior) correlate with measures of precapillary pulmonary pressure as assessed by right heart catheterization? Participants will be asked to wear a small sensor on the lower back for one week at a time for a total of 3 times: at diagnosis and follow-up visits at 3-6 months and again at 6-12 months. Follow-up visits are scheduled by the treating clinician. At the end of the study participants can choose to receive feedback on the sensor measurements.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
77
Start Date
2024-04-19
Completion Date
2027-04
Last Updated
2025-08-22
Healthy Volunteers
No
Conditions
Interventions
Accelerometer (measurement of walking activity)
Wearing an accelerometer (size 23x32,5x8,9 mm, weight 11g) on the lower back consistently for one week at a time to measure walking activity. The sensor is fixed with waterproof plasters. No feedback is given to the participant while wearing the sensor and no data can be read directly from the sensor.
Locations (4)
Robert Bosch Hospital
Stuttgart, Baden-Wurttemberg, Germany
Internal Medicine Clinic V, Ludwig-Maximilians-University Clinic
Munich, Bavaria, Germany
Klinikum Nuremberg
Nuremberg, Bavaria, Germany
SLK-Kliniken Heilbronn GmbH - Fachklinik Löwenstein
Löwenstein, Germany