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NCT06549452 · ClinicalTrials.gov registry record · NA
Mobile Health Intervention to Improve Exercise in Pediatric PH
A NA study of Pulmonary Arterial Hypertension, sponsored by Vanderbilt University Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT06549452: Recruiting NA study of Pulmonary Arterial Hypertension, sponsored by Vanderbilt University Medical Center.
NCT06549452 is a NA study of Pulmonary Arterial Hypertension that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 50 participants, below the 462-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06549452, a NA study of Pulmonary Arterial Hypertension, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
Children and adults with pulmonary arterial hypertension (PAH) have severely reduced daily activity compared to healthy populations. In adults, investigators recently demonstrated that lower baseline daily step counts associated with increased risk of hospitalization and worsening WHO functional class; similarly, reduced step counts associate with hospitalization in children with PAH. This application builds on our recently completed NIH-funded pilot mobile health (mHealth) trial in adult patients with PAH which demonstrated the ability to remotely increase step counts. The investigators now aim to: (1) adapt our mHealth intervention to the developmental needs and interests of adolescents; and, (2) determine if our intervention increases step counts in adolescents, providing the foundation for a larger trial to assess the impact on quality of life and clinical outcomes.
Primary Outcome
To assess the effect of a mHealth intervention or no intervention on average daily step count from baseline to 12 weeks. Accelerometry is a direct measure of physical activity in patients' day-to-day lives. Step counts will be measured using the Fitbit device monitor, a lightweight device that has a three-axis acceleration sensor, altimeter, vibration motor, and optical heart rate monitor.
Conditions Studied
Interventions
- DEVICE mHealth Intervention
- DEVICE Usual Care
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-12-01 |
| Est. Completion | 2030-11-01 |
| Phase | NA |
What NCT06549452 shows while recruiting
NCT06549452 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 462-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Pulmonary Arterial Hypertension appearing as the primary indexed condition, and to 2 interventions - of which mHealth Intervention is the first listed.
NCT06549452 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT06549452 about?
NCT06549452 is a clinical study titled "Mobile Health Intervention to Improve Exercise in Pediatric PH". Children and adults with pulmonary arterial hypertension (PAH) have severely reduced daily activity compared to healthy populations. In adults, investigators recently demonstrated that lower baseline daily step counts associated with increased risk of hospitalization and worsening WHO functional cla...
What is the current status of trial NCT06549452?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2024-12-01. Estimated completion is 2030-11-01.
What conditions does trial NCT06549452 study?
This clinical trial studies the following conditions: Pulmonary Arterial Hypertension.
What interventions are being tested in trial NCT06549452?
The interventions under investigation include: mHealth Intervention (DEVICE), Usual Care (DEVICE).
Who is sponsoring clinical trial NCT06549452?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06549452 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pulmonary Arterial Hypertension
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06549452's enrollment target sits among peer trials
50 32nd of 63 higher than 32 of 63 other Pulmonary Arterial Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Arterial Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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