Clinical trial NCT06819059: Safety and Effectiveness of a Virtual Pediatric Cardiac Rehabilitation Program or Telerehabilitation in Children With Heart Disease
Official title: Safety and Efficacy of Pediatric Cardiac Telerehabilitation in Adolescents With Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Abnormalities
Pulmonary Arterial Hypertension (PAH)
Orthotopic Heart Transplant
Cardiac Rehabilitation
Pediatric Cardiology
Telehealth
Telerehabilitation
Keywords: Pediatric Cardiac Telerehabilitation
Pediatric Exercise
Cardiac Rehabilitation
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Sessions Completed
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in exercise time
timeFrame: 12 weeks
measure: Change in Anxiety associated with exercise (ESQ -18)
timeFrame: 12 weeks
measure: Change in Disease Burden by lower Quality of Life Measure
timeFrame: 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center - New York Presbyterian's Morgan Stanley's Children's Hospital
state: New York
Study officials:
affiliation: Columbia University
name: Aimee M Layton, PhD
role: PRINCIPAL_INVESTIGATOR
References: