Clinical trials / NCT05442671
Recruiting

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

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…

ClinicalTrials.gov IDNCT05442671
PhaseNA
Enrollment25
SponsorChildren's Hospital of Philadelphia
Age8 Years
SexALL
I'm interested View official listing

Conditions studied

Pulmonary Hypertension

About this study

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.

Interventions

Primary outcomes

Eligibility information

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 locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.