Digital Assessment of Real-World Walking Activity in Pulmonary Hypertension: A Prospective Multicenter Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Accelerometer (measurement of walking activity).
- Who it may be relevant to
- Registry conditions: Pulmonary Hypertension, Precapillary Pulmonary Hypertension, Right Heart Catheterisation, Digital Mobility Outcomes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device 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.
Primary outcome measures
- Correlation of digital mobility assessments with measured pulmonary arterial pressures [Time frame: Baseline assessment at first diagnosis, follow-up assessments after 3-6 months and again after 6-12 months (follow-up time frames are determined by the treating clinician).]
Secondary outcome measures (6)
- Description of the general daily walking behaviour of patients with precapillary pulmonary hypertension: amount of walking episodes [Time frame: Measured at diagnosis (baseline visit) and two follow-up visits (between 3-6 months and again after 6-12 months, as determined by the treating clinician).]
- Description of the general daily walking behaviour of patients with precapillary pulmonary hypertension: duration of walking episodes [Time frame: Measured at diagnosis (baseline visit) and two follow-up visits (between 3-6 months and again after 6-12 months, as determined by the treating clinician).]
- Description of the general daily walking behaviour of patients with precapillary pulmonary hypertension: amount of steps [Time frame: Measured at diagnosis (baseline visit) and two follow-up visits (between 3-6 months and again after 6-12 months, as determined by the treating clinician).]
- Correlation between validated digital mobility outcomes and important prognostic markers of cardiac function [Time frame: Measured at diagnosis (baseline visit) and two follow-up visits (between 3-6 months and again after 6-12 months, as determined by the treating clinician).]
- Correlation between digital mobility outcomes and disease progression [Time frame: Measured at diagnosis (baseline visit) and two follow-up visits (between 3-6 months and again after 6-12 months, as determined by the treating clinician).]
- Investigation of potential confounders [Time frame: From enrollment to end of study after the last follow-up visit at 6-12 months.]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 4 centers
- Robert Bosch Hospital — Stuttgart
- Internal Medicine Clinic V, Ludwig-Maximilians-University Clinic — Munich
- Klinikum Nuremberg — Nuremberg
- SLK-Kliniken Heilbronn GmbH - Fachklinik Löwenstein — Löwenstein
Identifiers
NCT: NCT07137260 · CPN_PMU001