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

NCT06819059 | Completed

• 1 other identifier: AAAT7872
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Pediatric Cardiac Telerehabilitation; Pediatric Exercise; Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Number of Sessions Completed

  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.

  12 weeks

Secondary Outcomes (3)

• Change in exercise time

  12 weeks

• Change in Anxiety associated with exercise (ESQ -18)

  12 weeks

• Change in Disease Burden by lower Quality of Life Measure

  12 weeks

Study Arms (2)

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

EXPERIMENTAL

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.

Behavioral: Pediatric Cardiac Telerehabilitation; Behavioral: Fitness Tracker Only

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

ACTIVE COMPARATOR

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.

Behavioral: Fitness Tracker Only

Interventions

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.

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

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.

Arm 1 is the treatment arm that receives 12 weeks of weekly cardiac telerehabilitation sessions; Arm 2 was the study arm for participants randomized to the control group

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

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

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Congenital Abnormalities; Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Aimee M Layton, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Applied Physiology in Pediatrics

Model Details: Randomized Control Trial, with optional cross over for control participants to receive the treatment after completing 3 months of control data collection and post 3 month enrollment follow up testing.

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 11, 2025
• Study Start: May 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: February 1, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

US (1)