RecruitingNCT07137260

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


Sponsor

Simon Jäger

Enrollment

77 participants

Start Date

Apr 19, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using a small wearable sensor to track how much people with pulmonary hypertension (high blood pressure in the lungs) actually walk in their daily lives outside of a clinical setting. Researchers want to see if real-world activity levels provide useful information about disease progression. **You may be eligible if...** - You have been diagnosed with pulmonary hypertension confirmed by a heart catheterization procedure - You can walk independently (without assistance) and can walk more than 100 meters in 6 minutes - Your disease is classified as WHO Functional Class I, II, or III (mild to moderate symptoms) - You are willing to wear a small movement sensor on your ankle for 7 days - You have a follow-up visit scheduled in 3, 6, or 12 months **You may NOT be eligible if...** - You were hospitalized for a lung condition in the 30 days before joining the study - You cannot walk independently or your 6-minute walking distance is under 100 meters - You are unwilling or unable to wear the activity sensor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEAccelerometer (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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07137260


Related Trials