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

NCT05442671 | Recruiting DMC

• 2 other identifiers: 20-0181681K23HL150337-01A1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pulmonary Hypertension

Keywords

Actigraphy

Outcome Measures

Primary Outcomes (1)

• Change in moderate to vigorous physical activity (MVPA)

  Change in MVPA (min/day) will be measured by smartwatch accelerometer from baseline over the course of the intervention

  Pre-exercise intervention and Post intervention (within 2 weeks of completion of the 16-week exercise intervention)

Secondary Outcomes (3)

• Change in leg lean mass Z-score (LLMZ)

  Pre-exercise intervention and Post intervention (within 2 weeks of completion of the 16-week exercise intervention)

• Change in muscle strength

  Pre-exercise intervention and Post intervention (within 2 weeks of completion of the 16-week exercise intervention)

• Change in quality of life score

  Pre-exercise intervention and Post intervention (within 2 weeks of completion of the 16-week exercise intervention)

Study Arms (1)

Home exercise intervention

OTHER

* 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.

Behavioral: Exercise intervention

Interventions

Exercise intervention BEHAVIORAL

16-week home exercise intervention, enriched by mobile health technology

Home exercise intervention

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Catherine Avitabile, MD

CONTACT

215-590-4040; avitabilec@chop.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: July 5, 2022
• Study Start: April 3, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)