Safety and Effectiveness of a Virtual Pediatric Cardiac Rehabilitation Program or Telerehabilitation in Children with Heart Disease

Phase

N/A

Condition

Pulmonary Arterial Hypertension

Holoprosencephaly

Pediatric Health

Treatment

Pediatric Cardiac Telerehabilitation

Fitness Tracker Only

Clinical Study ID

NCT06819059

AAAT7872

Ages 10-25
All Genders

Study Summary

Cardiac telerehabilitation is a much-needed pediatric therapy; however, a lack of randomized controlled trials has limited the development of and reimbursement for this valuable service. Through this prospective, randomized controlled trial, the investigators aim to demonstrate the safety and efficacy of PCTR in a clinically diverse population of children and adolescents with heart disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age 10 -25 yrs
Not participating in organized sports of physical fitness programs
Able to follow basic directions and express symptoms
Dx of pulmonary hypertension, congenital heart disease, and transplant programs
Clinically stable as deemed by the referring cardiologist

Exclusion

Exclusion Criteria:

Clinical instability as demonstrated by recent medication escalation (within 3months prior to starting the program)
Hemodynamic instability
Significant arrhythmia or ST segment or T wave abnormalities
End-tidal carbon dioxide less than 20 mmHg with exercise, or exercise-inducedsymptoms that would limit ability to participate in the intervention safely

Study Design

Pediatric Cardiac Telerehabilitation

May 01, 2023

February 01, 2025

Study Description

This is a single center, prospective, randomized, controlled pilot of a pediatric cardiac telerehabilitation program in adolescents with acquired or congenital heart disease.

Because of the known benefits of exercise, controls were offered the opportunity to participate in the intervention group after completing the 12 weeks in the control group.

Participants were randomized in a 2:1 ratio (intervention: control) to maximize participation in the exercise intervention. Participants were from three core populations: primary or secondary pulmonary hypertension (PH), structural congenital heart disease (CHD), and post-orthotopic heart transplant (OHT). PCTR was "semi-supervised", where one day per week the participant exercised one-on-one with a physical therapist or exercise physiologist via virtual platform and 2 days per week they exercised independently. Participants wore an activity tracker with heart rate monitoring 24 hours a day and a single lead, chest-based electrocardiogram (ECG) device while exercising. A physician or program director reviewed ECGs after all sessions. An adult had to be available in case of an emergency during each session. Controls received weekly check-ins and a Fitbit but did not receive a formal exercise prescription. All participants underwent baseline and post-study assessments including the cardiopulmonary stress test (CPET) and questionnaires and wore their Fitbits for the duration of the study.

Compliance was measured by attendance of Zoom appointments, Fitbit activity data, Wellue single lead electrocardiogram (ECG) data, and self-reported activity performed. Efficacy was measured by CPET results, validated questionnaire data and activity levels as determined by Fitbit data.

Connect with a study center

Columbia University Medical Center - New York Presbyterian's Morgan Stanley's Children's Hospital
New York, New York 10032
United States
Site Not Available

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