Mobile health program to boost exercise in teens with pulmonary arterial hypertension
MhOVE-PPH Study: Mobile Health Intervention to Improve Exercise in Pediatric PH
This study is testing a mobile health program to see if it can help teenagers with pulmonary arterial hypertension get more exercise.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 10 Years to 21 Years |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT06549452 on ClinicalTrials.gov |
What this trial studies
This intervention focuses on adolescents aged 13-19 diagnosed with pulmonary arterial hypertension (PAH) to improve their daily physical activity through a mobile health (mHealth) program. Building on previous research in adults, the study aims to adapt the mHealth intervention to meet the developmental needs of younger patients. The primary goal is to determine if this tailored approach can effectively increase step counts among participants, laying the groundwork for future studies on its impact on quality of life and clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 13-19 with a diagnosis of idiopathic, heritable, or associated pulmonary arterial hypertension who are stable on their medication regimen.
Not a fit: Patients who are wheelchair-bound, bed-bound, or have other severe activity limitations will not benefit from this intervention.
Why it matters
Potential benefit: If successful, this program could significantly enhance physical activity levels and overall quality of life for adolescents with PAH.
How similar studies have performed: Previous studies in adults have shown success in using mobile health interventions to increase physical activity in patients with PAH, suggesting potential for similar outcomes in adolescents.
Eligibility criteria
Show full inclusion / exclusion criteria
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. * Pregnancy * 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 this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Eric Austin, MD — Vanderbilt University Medical Center
- Study coordinator: Natasha Billard
- Email: natasha.billard.1@vumc.org
- Phone: (434) 851-3306
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.