Mobile Health Intervention to Improve Exercise in Pediatric PH
- Conditions
- Pulmonary Arterial Hypertension
- Registration Number
- NCT06549452
- Lead Sponsor
- Vanderbilt University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria:<br><br> - Adolescents between ages 13-19 years.<br><br> - Diagnosed with idiopathic, heritable, or associated (connective tissue disease,<br> drugs, or toxins) pulmonary arterial hypertension (PAH), or PAH due to simple<br> congenital heart disease (i.e. atrial septal defect).<br><br> - WHO functional class I-III<br><br> - Stable PAH-specific medication regimen for three months prior to enrollment.<br> Subjects with only a single diuretic adjustment in the prior three months will be<br> included. Adjustments in IV prostacyclin for side effect management are allowed.<br><br> - Forced vital capacity >65% predicted with no or minimal interstitial lung disease<br> based on reviews of imaging studies by PI and medical monitor.<br><br>Exclusion Criteria:<br><br> - Prohibited from normal activity due to wheelchair bound status, bed bound status,<br> reliance on a cane/walker, activity-limiting angina, activity-limiting<br> osteoarthritis, or other condition that limits activity.<br><br> - Pregnancy<br><br> - Diagnosis of PAH etiology other than idiopathic, heritable, or associated.<br><br> - Functional class IV heart failure<br><br> - Requirement of > 2 diuretic adjustment in the prior three months.<br><br> - Preferred form of activity is not measured by an activity tracker (swimming, yoga,<br> ice skating, stair master, or activities on wheels such as bicycling or<br> rollerblading).<br><br> - Involved in any other investigational intervention.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in average daily step count from baseline to 12 weeks
- Secondary Outcome Measures
Name Time Method