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

Description

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.

Conditions

Pulmonary Hypertension

Study Overview

Study Details

Study overview

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.

Home Exercise Training in Pediatric Pulmonary Hypertension

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

Condition
Pulmonary Hypertension
Intervention / Treatment

-

Contacts and Locations

Philadelphia

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 on most recent cardiac catheterization
  • * Completion of a cardiopulmonary exercise (CPET) test within 3 months
  • * Stable PH medication regimen for 3 months prior to the intervention
  • * Home Wifi connection
  • * Mobile device in family capable of receiving text messages
  • * 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

Ages Eligible for Study

8 Years to 18 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's Hospital of Philadelphia,

Study Record Dates

2026-12-31