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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT05442671
Status
Recruiting
Apply to this trial

Conditions

  • Pulmonary Hypertension

Eligibility Criteria

Sex
ALL
Age
8 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Exercise intervention — BEHAVIORAL
    16-week home exercise intervention, enriched by mobile health technology

Study Details

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.

Key Dates

Start date
Apr 3, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Home exercise intervention
    * Personalized 16 week home exercise program - aerobic exercise for 20 minutes per day/4 days per week and light resistance exercise using resistance bands 3 days per week. * Aerobic sessions will include walking, biking, or light jogging, depending on access to facilities/equipment and weather. * Smartwatch for the length of the intervention and a heart rate monitor during exercise sessions. * Max heart rate prescribed will be 80% of that on recent cardiopulmonary exercise test (at most 150 beats/min). * Heart rate monitor will sync with the smartwatch. * Activity and heart rate data will be transmitted to the study team via a data hub connected to the participant's home internet modem several times per week. * Periodic text messaging to remind participants to wear the watch, sync the data, or adhere to heart rate goals, to ask about symptoms, or to support activity progress. * Multiple ways to contact the study team with questions or concerns.

Primary Outcome Measure

Change in moderate to vigorous physical activity (MVPA) [ Time Frame: Pre-exercise intervention and Post intervention (within 2 weeks of completion of the 16-week exercise intervention) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Catherine Avitabile, MD
[email protected]

Find similar trials in Philadelphia, PA

By research site
Children's Hospital of Philadelphia· Philadelphia, PA

Related Studies