Actively Recruiting
iTONE Trial (exercIse Training in pulmONary hypertEnsion) Exercise Program for Pediatric PH
Led by Children's Hospital of Philadelphia · Updated on 2026-04-22
25
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital of Philadelphia
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
iTONE Trial (exercIse Training in pulmONary hypertEnsion) Exercise Program for Pediatric PH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 8-18 years
- Diagnosed with pulmonary hypertension WHO diagnostic groups 1, 2, 3, or 4
- WHO functional class I or II
- Able to walk and move around independently (ambulatory)
- Mean pulmonary to systemic arterial pressure ratio less than 0.75 if no Potts shunt, or Potts shunt placed at least 6 months before enrollment
- Stable pulmonary hypertension medication for at least 3 months before the exercise program
- Access to home Wi-Fi
- Family has a mobile device capable of receiving text messages
You will not qualify if you...
- WHO functional class III or IV
- Single ventricle heart physiology
- Moderate to severe kidney disease (greater than stage 3)
- Severe liver impairment with enzyme levels more than twice the upper limit of normal
- Currently pregnant
- Significant developmental delay or inability to follow verbal instructions for study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
C
Catherine Avitabile, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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