Digital Assessment of Real-World Walking Activity in Pulmonary Hypertension: A Prospective Multicenter Trial

Обзор

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Correlation of digital mobility assessments with measured pulmonary arterial pressures [Срок оценки: 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).]

Вторичные конечные точки (6)

• Description of the general daily walking behaviour of patients with precapillary pulmonary hypertension: amount of walking episodes [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From enrollment to end of study after the last follow-up visit at 6-12 months.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 4 центра

• Robert Bosch Hospital — Stuttgart
• Internal Medicine Clinic V, Ludwig-Maximilians-University Clinic — Munich
• Klinikum Nuremberg — Nuremberg
• SLK-Kliniken Heilbronn GmbH - Fachklinik Löwenstein — Löwenstein

Идентификаторы

NCT: NCT07137260 · CPN_PMU001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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