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

Home Exercise Training in Pediatric Pulmonary Hypertension

Who can join

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

Age
8 Years to 18 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

  • Procedures mentioned: Wearing a device

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This study will use wearable activity monitoring devices to promote physical activity in a 16-week pilot intervention in children and teenager with PH."
  • "Wearable accelerometer sensors with wireless transmission capabilities allow us to measure relevant endpoints from a patient's daily life."
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 16-week exercise program for children and teens ages 8–18 with pulmonary hypertension (PH), or high blood pressure in the lungs. It uses wearable activity trackers to encourage more movement and may help improve exercise ability and quality of life.

Children with pulmonary hypertension (PH) engage in less physical activity than their peers. This is a concern since adult data support exercise as a non-pharmacologic treatment for PH. Despite adult data, therapeutic exercise has not been widely adopted in pediatric PH. Investigators have previously demonstrated that children with PH have less skeletal muscle mass in association with worse exercise performance. Interventions to increase physical activity and skeletal muscle mass may improve exercise performance and quality of life in children with PH. This study will use wearable activity monitoring devices to promote physical activity in a 16-week pilot intervention in children and teenager with PH.

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

Eligibility

Who can join

  • Are 8–18 years old.
  • Have PH in WHO group 1, 2, 3, or 4: PH linked to lung arteries, left heart disease, lung disease, or long-term blood clots in the lungs.
  • Have WHO class I or II PH, meaning no or only slight limits on physical activity.
  • Can walk.
  • Have average lung artery pressure less than 75% of body artery pressure, or had a Potts shunt placed at least 6 months ago. This shunt connects a lung artery to a body artery.
  • Have been on a stable PH medicine plan for 3 months before the program.
  • Have Wi-Fi at home.
  • Have a mobile device in the family that can receive text messages.

Who can't join

  • Have WHO class III or IV PH, meaning major limits on activity or symptoms even at rest.
  • Have a heart with only one working lower chamber.
  • Have kidney disease beyond stage 3.
  • Have severe liver problems, with AST or ALT liver blood tests more than twice the upper normal limit.
  • Are pregnant.
  • Have a major delay in development or cannot follow spoken instructions to complete study tasks.

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

Official eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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

Study sites (1)

PA