RecruitingRecruiting
Mobile Health Intervention to Improve Exercise in Pediatric PH
NCT06549452 · Vanderbilt University Medical Center
In plain English
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Official title
MhOVE-PPH Study: Mobile Health Intervention to Improve Exercise in Pediatric PH
About this study
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.
Eligibility 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.
Study design
Enrollment target: 50 participants
Allocation: randomized
Masking: none
Age groups: child, adult
Timeline
Starts: 2024-12-01
Estimated completion: 2030-11-01
Last updated: 2026-03-27
Interventions
Device: mHealth InterventionDevice: Usual Care
Primary outcomes
- • Change in average daily step count from baseline to 12 weeks (Baseline to 12 weeks)
Sponsor
Vanderbilt University Medical Center · other
With: University of California, San Francisco, National Heart, Lung, and Blood Institute (NHLBI)
Contacts & investigators
ContactNatasha Billard · contact · natasha.billard.1@vumc.org · (434) 851-3306
ContactEric Austin, MD · contact · eric.austin@vumc.org · (615) 343-7617
InvestigatorEric Austin, MD · principal_investigator, Vanderbilt University Medical Center
All locations (1)
Vanderbilt University Medical CenterRecruiting
Nashville, Tennessee, United States