RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Home Exercise Training in Pediatric Pulmonary Hypertension

Quick Facts

Study Start:2024-04-03
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05442671

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.

Ages Eligible for Study:8 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 8-18 years
  2. * 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)
  3. * WHO functional class I or II
  4. * Ambulatory status
  5. * Mean pulmonary to systemic arterial pressure ratio \<0.75 on most recent cardiac catheterization
  6. * Completion of a cardiopulmonary exercise (CPET) test within 3 months
  7. * Stable PH medication regimen for 3 months prior to the intervention
  8. * Home Wifi connection
  9. * Mobile device in family capable of receiving text messages
  1. * WHO functional class III or IV
  2. * Single ventricle physiology
  3. * Moderate to severe renal disease (\>stage 3)
  4. * Severe hepatic impairment \[aspartate aminotransferase (AST)/alanine transaminase (ALT) \> 2x upper limit of normal\]
  5. * Current pregnancy
  6. * Significant developmental delay/inability to comply with verbal instructions to complete the study procedures

Contacts and Locations

Study Contact

Catherine Avitabile, MD
CONTACT
215-590-4040
avitabilec@chop.edu

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Children's Hospital of Philadelphia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-03
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-04-03
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Actigraphy

Additional Relevant MeSH Terms

  • Pulmonary Hypertension