iTONE Trial (exercIse Training in pulmONary hypertEnsion) Exercise Program for Pediatric PH
Sponsored by Children's Hospital of Philadelphia
About this study
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.
Pediatric pulmonary hypertension (PH) is a rare disease, affecting 2-16 per million children. Without treatment, pulmonary vascular disease leads to right ventricular cardiac failure and death. Survival has improved with pharmacologic advances, however, 5-year survival from diagnosis is still only about 75%. Even with increased survival, pediatric PH is a severe, chronic illness with physical and psychosocial burdens affecting the quality of life of children and families. Exercise intolerance is nearly universal and adversely affects quality of life. While exercise physiology is complex, skeletal muscle deficits and dysfunction are important factors associated with exercise intolerance in adults with PH. The contraction of the skeletal muscle pump helps increase pulmonary blood flow at the…
Where this study is enrolling
- I'm interested
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania
Who can participate
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
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Trial data sourced from ClinicalTrials.gov.