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Completed

NCT Number: NCT06819059

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

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.

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Key information

Age range

10 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pediatric Cardiac Telerehabilitation

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

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.

Primary outcomes

  1. Number of Sessions Completed

    Time frame: 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 outcomes

  1. Change in exercise time

    Time frame: 12 weeks

    The study will measure the change in exercise duration pre- to post-intervention.

  2. Change in Anxiety associated with exercise (ESQ -18)

    Time frame: 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.

  3. Change in Disease Burden by lower Quality of Life Measure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Safety and Efficacy of Pediatric Cardiac Telerehabilitation in Adolescents With Heart Disease

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Feb 11, 2025
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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