Actively Recruiting
Remotely Delivered Cardiac Rehabilitation 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
26 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
This research aims to evaluate the effectiveness of delivering live-supervised cardiac rehabilitation exercise training remotely via video conferencing to adolescents aged 12 to 19 years with congenital heart disease (CHD). The study compares this remote cardiac rehab (RCR) approach to an active control group receiving exercise informational handouts. Adolescents with specific CHD diagnoses such as Fontan circulation, Tetralogy of Fallot, or dextro-transposition of the great vessels are included to assess improvements in fitness and heart function. Participants in the RCR group will first complete a 2-week ramp-up with one-on-one live exercise sessions led by a health coach using telehealth technology. This is followed by a 10-week period of group exercise sessions (3-5 participants per group) held at home three days per week for 45 minutes each. Exercises include aerobic and resistance training with heart rate targets and use of provided equipment. The control group receives exercise guidance handouts matching recommended physical activity for youth. Both groups participate in the 12-week intervention. Throughout the study, participants will undergo assessments at the beginning and after 12-13 weeks, measuring cardiorespiratory fitness, cardiac function via echocardiogram, body composition, frailty, physical function, quality of life, and physical activity confidence. Participants will wear activity monitors for at least six months to track physical activity. The study also gathers data on program satisfaction, participation, and demographic factors to understand their effects on fitness changes.
CONDITIONS
Brief 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 three 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 for exercise participation
- Internet access in their homes
- Available for in-home exercise between 4-7pm on at least 3 weekdays
- English speaking
- Achieved maximal effort on a cardiopulmonary exercise test (RER ≥1.1) or deemed maximal effort by supervising exercise physiologist with musculoskeletal limitation
You will not qualify if you...
- Physically or developmentally unable to perform outcome assessments or participate in moderate-to-vigorous exercise
- Participating in more than 15 MET-hours per week of organized athletic/exercise activity
- Height less than 132 cm
- Pregnancy or planned surgery or procedure (excluding outpatient, non-cardiac) within the 12-week study
- Exercise test safety or screening criteria not met at recent tests
- Significant cardiac dysfunction impairing safe exercise participation
- Significant new abnormalities on echocardiogram
- Uncontrolled or poorly controlled asthma
- Presence of implanted cardioverter-defibrillator
- Pacemaker with rate-responsive function initiated
- Reliance on ventricular assist device
- Prescribed milrinone medication
- Listed for heart transplantation
- Active hormone replacement therapy for gender transition
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants randomized to the remote cardiac rehab group will start with a 2-week ramp-up period of 1-on-1 live, remote in-home exercise sessions with a health coach. This is followed by 10 weeks of live, group-based exercise sessions, 3 days per week for 45 minutes each session, delivered remotely via telehealth. Participants in the active control group will receive handouts describing appropriate physical activities consistent with youth physical activity recommendations.
3 exercise sessions per week for 12 weeks (remote)
Duration - At least 6 months
Participants will be encouraged to wear a wrist-worn physical activity monitor throughout the 12-week intervention period and for at least 6 months afterward to monitor physical activity levels.
Ongoing activity monitoring (remote)
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
D
David Cloutier, MS, MBA
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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