Actively Recruiting
Remote Cardiac Rehab for Adolescents With Congenital Heart Disease
Led by Children's Mercy Hospital Kansas City · Updated on 2026-05-04
74
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
Sponsors
C
Children's Mercy Hospital Kansas City
Lead Sponsor
U
University of Kansas
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this randomized controlled trial is to evaluate the effectiveness of video conferencing for the delivery of live-supervised, real-time cardiac rehabilitation (CR) exercise training to groups of adolescents with congenital heart disease (CHD) in their homes. Participants will be randomized to either the remote cardiac rehab (RCR) group or active control group. The RCR group will participate in live, group-based exercise training (3-5 participants per exercise session), in their homes 3 days per week for 45 minutes over 12-weeks. Exercise sessions will be led and supervised by a live health coach via telehealth video technology. The active control group will be provided informational handouts on health exercise for their cardiac diagnosis. The primary aim is to compare between group changes (0-12-weeks) in cardiorespiratory fitness (VO2peak). Secondary aims are to compare between group changes (0-12-weeks) in cardiac function (echocardiography), lean body mass, and physical frailty. Exploratory aims will compare between group changes (0-12-weeks) in physical function, quality of life, skeletal muscle function, and physical activity self-efficacy. Additionally, exploratory aims will explore the impact of demographic characteristics, program participation, program satisfaction, and daily physical activity on changes in cardiorespiratory fitness.
CONDITIONS
Official Title
Remote Cardiac Rehab for Adolescents With Congenital Heart Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12-19 years old
- Male or female
- Diagnosed with one of these congenital heart diseases: univentricular heart with Fontan palliation, Tetralogy of Fallot with transannular patch, or dextro-transposition of the great arteries with arterial switch operation
- Primary cardiology clearance to participate in exercise
- Internet access at home
- Available for in-home exercise between 4-7pm on at least 3 weekdays
- English speaking
- Able to achieve maximal effort on a cardiopulmonary exercise test as defined by study criteria
You will not qualify if you...
- Physically or developmentally unable to perform outcome assessments or engage in moderate-to-vigorous exercise
- Participating in more than 15 MET-hours per week of organized athletic or exercise activity (excluding school physical education) over the past 12 months
- Height less than 132 cm
- Pregnant or planning surgery or procedures (except outpatient non-cardiac) during the 12-week study
- Meeting safety or screening criteria that prevent exercise participation on recent exercise tests
- Significant cardiac dysfunction impairing safe moderate-to-vigorous exercise
- Significant changes on recent echocardiogram such as decreased ventricular or valvar function, new obstruction, or new structural abnormalities
- Uncontrolled or poorly controlled asthma
- Presence of an implanted cardioverter-defibrillator
- Pacemaker with rate-responsive function activated
- Reliance on a ventricular assist device
- Prescribed milrinone medication
- Listed for heart transplantation
- Actively undergoing hormone replacement for gender transition
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Children's Mercy Kansas City
Kansas City, Missouri, United States, 64108
Actively Recruiting
Research Team
M
Madeline Donnelli, BS
CONTACT
D
David Cloutier, MS, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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