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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-18
SponsorChildren's Hospital of Philadelphia

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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]

Trial design

Treatments tested in this trial

  • Exercise intervention

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators

Children's Hospital of Philadelphia

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator