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

NCT ID: NCT06819059

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-02-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Pediatric Cardiac Telerehabilitation

Intervention Type: BEHAVIORAL

The program was entirely virtual except for pre and post program cardiopulmonary exercise testing. Patients were provided a stationary bicycle, hand weights, and resistance training bands. They exercised over zoom with a physical therapist or exercise physiologist weekly and were also asked to exercise independently 2x per week. Electrocardiograms (ECGs) were provided to the patients as a single lead monitor and results were shared with the study team after each session or during sessions if the patient reported symptoms. Compliance and activity data were recorded using Fitbit activity trackers.

Fitness Tracker Only

Intervention Type: BEHAVIORAL

Control participants were provided fitness trackers and weekly text messaging from the study team to synch their devises but no formal exercise training. They were allowed to enroll in the exercise training after completing 3 months as a control.

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

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.

Group Type: ACTIVE_COMPARATOR

Fitness Tracker Only

Intervention Type: BEHAVIORAL

Control participants were provided fitness trackers and weekly text messaging from the study team to synch their devises but no formal exercise training. They were allowed to enroll in the exercise training after completing 3 months as a control.

Interventions

Pediatric Cardiac Telerehabilitation

The program was entirely virtual except for pre and post program cardiopulmonary exercise testing. Patients were provided a stationary bicycle, hand weights, and resistance training bands. They exercised over zoom with a physical therapist or exercise physiologist weekly and were also asked to exercise independently 2x per week. Electrocardiograms (ECGs) were provided to the patients as a single lead monitor and results were shared with the study team after each session or during sessions if the patient reported symptoms. Compliance and activity data were recorded using Fitbit activity trackers.

Intervention Type: BEHAVIORAL

Fitness Tracker Only

Control participants were provided fitness trackers and weekly text messaging from the study team to synch their devises but no formal exercise training. They were allowed to enroll in the exercise training after completing 3 months as a control.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Aimee Layton

Associate Professor of Applied Physiology in Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aimee M Layton, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center - New York Presbyterian's Morgan Stanley's Children's Hospital

New York, New York, United States

Countries

United States

Other Identifiers

AAAT7872

Identifier Type: -

Identifier Source: org_study_id