NCT05442671Recruiting
iTONE Trial (exercIse Training in pulmONary hypertEnsion) Exercise Program for Pediatric PH
Home Exercise Training in Pediatric Pulmonary Hypertension
Source: ClinicalTrials.gov · Last updated 22 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 24 Jun 2022
- Start date
- 3 Apr 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Children's Hospital of Philadelphia
- NCT number
- NCT05442671
What you commit to
- Study type: Interventional
- Planned participants: 25
- From 3 Apr 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Moderate to severe renal disease (\>stage 3)
Lab values
- Severe hepatic impairment \[aspartate aminotransferase (AST)/alanine transaminase (ALT) \> 2x upper limit of normal\]
Other
- WHO functional class III or IV
- Single ventricle physiology
- Current pregnancy
- Significant developmental delay/inability to comply with verbal instructions to complete the study procedures
Who the study is looking for
- 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
Age in the registry: 8 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.