NCT05442671 iTONE Trial (exercIse Training in pulmONary hypertEnsion) Exercise Program for Pediatric PH
| NCT ID | NCT05442671 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Philadelphia |
| Condition | Pulmonary Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-04-03 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2024-04-03 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05442671 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 18 Years, studying Pulmonary Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05442671 currently recruiting?
Yes, NCT05442671 is actively recruiting participants. Contact the research team at avitabilec@chop.edu for enrollment information.
Where is the NCT05442671 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT05442671 clinical trial?
NCT05442671 is sponsored by Children's Hospital of Philadelphia. The trial plans to enroll 25 participants.