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

RecruitingNAAges 8 Years - 18 YearsAllChildren's Hospital of Philadelphia
NCT05442671 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Exercise intervention
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Where

1 site
Children's Hospital of Philadelphia
Philadelphia, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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