Actively Recruiting

Phase Not Applicable
Age: 10Years - 21Years
All Genders
NCT06549452

Mobile Health Intervention to Improve Exercise in Pediatric PH

Led by Vanderbilt University Medical Center · Updated on 2026-03-27

50

Participants Needed

1

Research Sites

308 weeks

Total Duration

On this page

Sponsors

V

Vanderbilt University Medical Center

Lead Sponsor

U

University of California, San Francisco

Collaborating Sponsor

AI-Summary

What this Trial 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. 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.

CONDITIONS

Official Title

Mobile Health Intervention to Improve Exercise in Pediatric PH

Who Can Participate

Age: 10Years - 21Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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, allowing only a single diuretic adjustment or adjustments in IV prostacyclin for side effect management
Not Eligible

You will not qualify if you...

  • Unable to perform normal activity due to wheelchair or bed bound status, reliance on cane/walker, or activity-limiting conditions such as angina or osteoarthritis
  • Pregnancy
  • Diagnosis of PAH other than idiopathic, heritable, or associated forms
  • Functional class IV heart failure
  • More than two diuretic adjustments in the prior three months
  • Preferred activities not measurable by activity tracker (e.g., swimming, yoga, ice skating, stair master, bicycling, rollerblading)
  • Participation in any other investigational intervention

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

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Research Team

N

Natasha Billard

CONTACT

E

Eric Austin, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Mobile Health Intervention to Improve Exercise in Pediatric PH | DecenTrialz