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iTONE Trial: Exercise Program for Pediatric Pulmonary Hypertension

This study, called the iTONE Trial, is looking at whether a 16-week home exercise program, supported by mobile health technology, can help children and teenagers with pulmonary hypertension (PH). PH is a rare condition where blood pressure in the arteries leading to the lungs is too high. We know that children with PH are less active than other kids, and in adults with PH, exercise can be a helpful treatment. This study will measure changes in your moderate to vigorous physical activity before and after the exercise program. You might be able to join if you are 8 to 18 years old, have certain types of PH (WHO groups 1, 2, 3, or 4), and can walk. The study aims to enroll 25 participants.

Study design
This is an interventional study planning to enroll 25 participants. It is not specified if it is randomized or blinded.
What's involved
You would participate in a 16-week home exercise intervention. Your physical activity will be measured before and within two weeks after the intervention.
Compensation
Not stated in the trial record.
Follow-up
Your physical activity will be measured within two weeks of completing the 16-week exercise intervention.

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NCT05442671

iTONE Trial (exercIse Training in pulmONary hypertEnsion) Exercise Program for Pediatric PH

Recruiting
NAAges 8–18InterventionalTreatment
Children's Hospital of Philadelphia
~25 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:Exercise intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in moderate to vigorous physical activity (MVPA)
Measured over Pre-exercise intervention and Post intervention (within 2 weeks of completion of the 16-week exercise intervention)

Conditions

Pulmonary Hypertension

Explore related trials

Pulmonary Hypertension

Where it's being run

1 sites across 1 states
Pennsylvania1

Who to contact

Catherine Avitabile, MD
[email protected]
215-590-4040
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age 8-18 years
PH World Health Organization (WHO) diagnostic groups 1, 2, 3, or 4 (pulmonary arterial hypertension, PH due to left heart disease, PH due to lung disease, chronic thromboembolic PH)
WHO functional class I or II
Ambulatory status
Mean pulmonary to systemic arterial pressure ratio \<0.75 if the patient has not undergone a pulmonary to systemic artery shunt ("Potts" shunt) OR the placement of a Potts shunt ≥ 6 months prior to study enrollment
Stable PH medication regimen for 3 months prior to the intervention
Home Wifi connection
Mobile device in family capable of receiving text messages

Exclusion

WHO functional class III or IV
Single ventricle physiology
Moderate to severe renal disease (\>stage 3)
Severe hepatic impairment \[aspartate aminotransferase (AST)/alanine transaminase (ALT) \> 2x upper limit of normal\]
Current pregnancy
Significant developmental delay/inability to comply with verbal instructions to complete the study procedures

What this trial measures

  • Change in moderate to vigorous physical activity (MVPA)Pre-exercise intervention and Post intervention (within 2 weeks of completion of the 16-week exercise intervention)

    Change in MVPA (min/day) will be measured by smartwatch accelerometer from baseline over the course of the intervention