NCT06549452Recruiting
Mobile Health Intervention to Improve Exercise in Pediatric PH
MhOVE-PPH Study: Mobile Health Intervention to Improve Exercise in Pediatric PH
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 24 Jun 2024
- Start date
- 1 Dec 2024
- Primary completion date
- 1 Nov 2028
- Lead sponsor
- Vanderbilt University Medical Center
- NCT number
- NCT06549452
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 1 Dec 2024 to the primary completion date, 1 Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Requirement of \> 2 diuretic adjustment in the prior three months.
Other illness
- 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.
- Functional class IV heart failure
Other
- Pregnancy
- Diagnosis of PAH etiology other than idiopathic, heritable, or associated.
- 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.
Who the study is looking for
- 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.
Age in the registry: 10 years to 21 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.