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

Columbia University

Status: Completed

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

Treatments: Behavioral: Pediatric Cardiac Telerehabilitation; Behavioral: Fitness Tracker Only

Study type: Interventional

Funder types: Other

Identifiers

NCT06819059

AAAT7872

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 10 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Arm 1 is the treatment arm that receives 12 weeks of weekly cardiac telerehabilitation sessions

Experimental group

Description:

The participants randomized to study Arm 1 were enrolled in the 12 weeks of cardiac telerehabilitation which included weekly one-on-one sessions with the exercise physiologist or physical therapist. Participants in this arm also received fitness activity trackers to record heart rate, active minutes, steps and sleep data.

Treatment:

Behavioral: Fitness Tracker Only

Behavioral: Pediatric Cardiac Telerehabilitation

Arm 2 was the study arm for participants randomized to the control group

Active Comparator group

Description:

Participants randomized to Arm 2 received fitness activity trackers that provided the patient with heart rate data, steps and sleep data but received no formal exercise training.

Treatment:

Behavioral: Fitness Tracker Only