Recruiting

Exercise Program

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT05442671

Conditions

Pulmonary Hypertension

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

Interventions

Exercise intervention

Study Details

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

Study ID

NCT05442671

Start date

Apr 3, 2024

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Exercise intervention

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

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 and Locations

Central contacts

Catherine Avitabile, MD

215-590-4040avitabilec@chop.edu

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Catherine Avitabile, MD

avitabilec@chop.edu

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

  • Actigraphy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2026-04-22.