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

Not Applicable

Completed

• Conditions: Pulmonary Arterial Hypertension (PAH); Pediatric Cardiology; Telehealth; Telerehabilitation; Orthotopic Heart Transplant; Cardiac Rehabilitation; Congenital Abnormalities

• Registration Number: NCT06819059
• Lead Sponsor: Columbia University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2023-05-01
• Primary Completion: 2024-11-01
• Status Verified: 2025-02
• Study Completion: 2025-02-01
• Study First Submitted: 2025-02-06
• Study First Submitted QC: 2025-02-06
• Last Update Submitted: 2025-02-06
• Study First Posted: 2025-02-11
• Last Update Posted: 2025-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 Criteria

• Clinical instability as demonstrated by recent medication escalation (within 3 months 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-induced symptoms that would limit ability to participate in the intervention safely

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Sessions Completed	12 weeks	The primary outcome of this study was compliance measured by drop out rate of the cardiac rehabilitation group and any adverse events that occurred with exercise.

Secondary Outcome Measures

Name	Time	Method
Change in exercise time	12 weeks	The study will measure the change in exercise duration pre- to post-intervention.
Change in Anxiety associated with exercise (ESQ -18)	12 weeks	The impact on anxiety associated with exercise before and after the program will be measured using the Exercise Sensitivity Questionnaire on a 0-72 scale. Lower score indicates better outcome.
Change in Disease Burden by lower Quality of Life Measure	12 weeks	The impact of disease burden on quality of life using the PedsQL questionnaire (Pediatric Quality of Life) with a 0-60 scale, with a lower score indicating a lesser impact.

Trial Locations

Locations (1)

Columbia University Medical Center - New York Presbyterian's Morgan Stanley's Children's Hospital; 🇺🇸 New York, New York, United States