NCT06549452 · Vanderbilt University Medical Center
Mobile Health Intervention to Improve Exercise in Pediatric PH
(MhOVE-PPH)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
mHealth Intervention
Our HIPPA-compliant texting platform is linked to the Fitabase Interface. Real time activity data are transmitted from the participant's smartphone to Fitabase via cellular network. Participants will receive 3-5 texts/day in sync with their preferred schedule defined at enrollment and taking into account school schedules as relevant. These texts use personal, disease-specific, and provider information to deliver two types of messages customized to the current step count and sent in equal proportion. Messages are designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.
DEVICE
Usual Care
Routine medical care
Primary outcome measures
Change in average daily step count from baseline to 12 weeks
Time frame: Baseline to 12 weeks
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adolescents between ages 10-21 years.
- Diagnosed with WHO Group 1 PAH or WHO Group 4 PH (CTEPH)
- WHO functional class I-III
- Stable PAH-specific medication regimen for three months prior to enrollment. Subjects with only a single diuretic adjustment in the prior three months will be included. Adjustments in IV prostacyclin for side effect management are allowed.
Exclusion criteria
- Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane/walker, activity-limiting angina, activity-limiting osteoarthritis, or other condition that limits activity.
- Diagnosis of PAH etiology other than idiopathic, heritable, or associated.
- Functional class IV heart failure
- Requirement of \> 2 diuretic adjustment in the prior three months.
- Preferred form of activity is not measured by an activity tracker (swimming, yoga, ice skating, stair master, or activities on wheels such as bicycling or rollerblading).
- Involved in any other investigational intervention.
Where
- Nashville, Tennessee
Collaborators
University of California, San Francisco, National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 27, 2026 · Source of record for eligibility and locations