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Mobile Health Intervention to Improve Exercise in Pediatric PH

MhOVE-PPH Study: Mobile Health Intervention to Improve Exercise in Pediatric PH

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
10 Years to 21 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a mobile health program to help young people with pulmonary hypertension (high blood pressure in the lungs) take more steps each day. It is for people ages 10–21 with certain types of this condition.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 10–21 years old.
  • You have Group 1 pulmonary arterial hypertension (PAH) or Group 4 pulmonary hypertension caused by long-term blood clots (CTEPH).
  • You are in WHO activity class I–III, meaning symptoms cause no to major limits on activity, but you are comfortable at rest.
  • Your PAH medicines have been stable for 3 months. One change to a diuretic (water pill) is allowed. Changes to IV prostacyclin, a medicine given into a vein, are allowed to manage side effects.

Who can't join

  • A health condition keeps you from normal activity. This includes being unable to leave a bed, needing a wheelchair, cane, or walker, or having chest pain or joint disease that limits activity.
  • You are pregnant.
  • Your PAH is not one of these types: unknown cause, inherited, or linked to another condition.
  • You have class IV heart failure, with symptoms even at rest.
  • You have needed more than 2 changes to a diuretic (water pill) in the past 3 months.
  • Your favorite activity cannot be measured by the activity tracker, such as swimming, yoga, ice skating, using a stair machine, biking, or rollerblading.
  • You are taking part in another study that tests a treatment or program.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (1)

TN