RecruitingNot ApplicableNCT05442671

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

Home Exercise Training in Pediatric Pulmonary Hypertension

Sponsor

Children's Hospital of Philadelphia

Enrollment

25 participants

Start Date

Apr 3, 2024

Study Type

INTERVENTIONAL

Conditions

Pulmonary Hypertension

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

Min Age: 8 YearsMax Age: 18 Years

Inclusion Criteria8

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 on most recent cardiac catheterization
Stable PH medication regimen for 3 months prior to the intervention
Home Wifi connection
Mobile device in family capable of receiving text messages

Exclusion Criteria6

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