Wearable sensor tracking of walking in adults with precapillary pulmonary hypertension
Digital Assessment of Real-World Walking Activity in Pulmonary Hypertension: A Prospective Multicenter Trial
This project will test whether a small wearable sensor that tracks walking can show changes that match pressures measured during right heart catheterization in adults with precapillary pulmonary hypertension.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 77 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Paracelsus Medical University Academic / other |
| Locations | 4 sites (Stuttgart, Baden-Wurttemberg and 3 other locations) |
| Trial ID | NCT07137260 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter observational effort enrolling adults with precapillary pulmonary hypertension confirmed by right heart catheterization. Participants wear an Axivity AX6 sensor on the lower back for one week at baseline and again at two scheduled follow-ups (around 3–6 months and 6–12 months) while clinical care continues per their physician. The main goal is to see whether digital mobility outcomes derived from accelerometer data correlate with invasive measures of pulmonary arterial pressure and resistance obtained by right heart catheterization. Data are collected at academic hospitals in Stuttgart, Munich, and Nuremberg, and participants can opt to receive feedback about their sensor measurements.
Who should consider this trial
Good fit: Adults with precapillary pulmonary hypertension confirmed by right heart catheterization, WHO Functional Class I–III, who can walk independently >100 m and are willing to wear the AX6 sensor and attend follow-up visits are ideal candidates.
Not a fit: Patients with limited walking ability due to neurological or orthopedic disease, recent pulmonology hospitalization, acute pain limiting walking, poor vision affecting mobility, terminal illness, or inability to consent or wear the sensor are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could provide a simpler, more continuous way to monitor walking ability and disease changes that complements or reduces the need for frequent invasive testing.
How similar studies have performed: Prior work has shown that digital mobility measures can be meaningful in chronic cardiopulmonary conditions, but direct validation against right heart catheterization in precapillary pulmonary hypertension remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Hospitalization for a pulmonological disease within the 30 days prior to study recruitment * Neurological or orthopedic disease which limits walking ability * Acute pain which limits walking ability * Poor vision, which limits walking ability * Terminal illness with life expectancy \< 1 year * Ongoing treatment for malignancy * Acute psychosis or other severe psychiatric illness * Substance dependence
Where this trial is running
Stuttgart, Baden-Wurttemberg and 3 other locations
- Robert Bosch Hospital — Stuttgart, Baden-Wurttemberg, Germany (Recruiting)
- Internal Medicine Clinic V, Ludwig-Maximilians-University Clinic — Munich, Bavaria, Germany (Recruiting)
- Klinikum Nuremberg — Nuremberg, Bavaria, Germany (Recruiting)
- SLK-Kliniken Heilbronn GmbH - Fachklinik Löwenstein — Löwenstein, Germany (Not_yet_recruiting)
Study contacts
- Study coordinator: Prof. Dr. med. Simon Jäger
- Email: simon.jaeger@klinikum-nuernberg.de
- Phone: +49 911-398-2822
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.