Tracking walking activity with a sensor in adults with pulmonary hypertension
Tests a back-worn sensor that measures walking in adults with pulmonary hypertension.
Plain-language title generated from the registry record
Registry title: Digital Assessment of Real-World Walking Activity in Pulmonary Hypertension: A Prospective Multicenter Trial
Key facts
- Where
- Löwenstein, Munich, Nuremberg, and Stuttgart, GermanySee the 4 sites
Where in Germany
- SLK-Kliniken Heilbronn GmbH - Fachklinik LöwensteinLöwenstein, GermanyNot yet recruiting
- Internal Medicine Clinic V, Ludwig-Maximilians-University ClinicMunich, GermanyTaking people
- Klinikum NurembergNuremberg, GermanyTaking people
- Robert-Bosch-HospitalStuttgart, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Simon Jäger
- Trial code
- NCT07137260
- Record updated
- 22 August 2025
- Original description
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:Read full original descriptionShow less
Digital Assessment of Real-World Walking Activity in Pulmonary Hypertension: A Prospective Multicenter Trial
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.
Inclusion: Pulmonary hypertension confirmed by right heart catheterization; Presence of precapillary pulmonary hypertension at time of recruitment, defined as mean pulmonary arterial pressure (MAP) ≥ 20 mmHg, pulmonary arterial wedge pressure (PAWP) ≤ 15 mmHg and pulmonary vascular resistance (PVR) > 2 Wood units (160 dyn·s·cm-5); After the right heart catheterization another follow-up visit is required in 3, 6, or 12 months; Independent walking without assistance and a 6-min walking distance > 100m; WHO Functional Class I-III; Ability to provide informed consent and to participate in the study procedures; Willingness to wear the Axivity AX6 Sensor for 7 days.
Exclusion: Hospitalization for a pulmonological disease within the 30 days prior to study recruitment; Neurological or orthopedic disease which limits walking ability; Terminal illness with life expectancy < 1 year; Ongoing treatment for malignancy; Acute psychosis or other severe psychiatric illness; Acute pain which limits walking ability; Poor vision, which limits walking ability; Substance dependence.