Exercise program for children with pulmonary hypertension
Home Exercise Training in Pediatric Pulmonary Hypertension
This study is testing a 16-week exercise program to help children and teenagers with pulmonary hypertension get more active and feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 8 Years to 18 Years |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05442671 on ClinicalTrials.gov |
What this trial studies
This intervention focuses on increasing physical activity in children and teenagers aged 8-18 with pulmonary hypertension (PH) through a 16-week exercise program. Utilizing wearable activity monitoring devices, the study aims to promote exercise and improve skeletal muscle mass, which is often deficient in this population. The program targets children with WHO functional class I or II PH, who are ambulatory and have stable medication regimens. By addressing exercise intolerance, the study seeks to enhance both exercise performance and quality of life for these young patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children and teenagers aged 8-18 with pulmonary hypertension classified as WHO functional class I or II.
Not a fit: Patients with more severe functional class III or IV pulmonary hypertension or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve exercise performance and overall quality of life for children with pulmonary hypertension.
How similar studies have performed: Recent trials have shown success in improving exercise performance in adults with pulmonary hypertension through prescribed exercise training, suggesting potential for similar benefits in pediatric populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 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
Exclusion Criteria:
* 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
Where this trial is running
Philadelphia, Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Catherine Avitabile, MD
- Email: avitabilec@chop.edu
- Phone: 215-590-4040
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.