Status:
RECRUITING
Remote Cardiac Rehab for Adolescents With Congenital Heart Disease
Lead Sponsor:
Children's Mercy Hospital Kansas City
Collaborating Sponsors:
University of Kansas
Children's Hospital of Philadelphia
Conditions:
Congenital Heart Disease in Children
Eligibility:
All Genders
12-19 years
Phase:
NA
Brief Summary
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 grou...
Detailed Description
This randomized controlled trial will evaluate the effectiveness of live, in-home, group-based cardiac rehabilitation (CR) exercise training compared to standard care (active) control. Participants wi...
Eligibility Criteria
Inclusion
- 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 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 days of the Monday-Friday work week
- English Speaking
- Achieving maximal effort on a cardiopulmonary exercise test, defined as RER ≥1.1 and/or in the judgement of the supervising exercise physiologist, a maximal effort was achieved but exercise capacity is limited by musculoskeletal deconditioning.
Exclusion
- Physically or developmentally unable to perform outcomes assessments or participate in moderate-to-vigorous intensity physical activity
- Participating in \> 15 MET-hours per week (mean weekly average over the past 12-months) of organized athletic/exercise activity (not including school physical education class).
- Height less than 132cm
- Pregnancy or planned surgery or procedure (excluding outpatient, non-cardiac procedures) within the 12-week study period.
- Meeting at least 1 exercise test safety or screening criteria on most recent exercise test (pre-study) or baseline outcomes visit exercise test
- Presence of significant cardiac dysfunction that would impair safe participation in moderate-to-vigorous intensity exercise
- Significant changes baseline echocardiogram or most recent clinical echocardiogram (from past clinical echocardiogram) such as decrease in ventricular and/or valvar function, new obstruction, or any new structural abnormalities
- 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 engagement in hormone replacement for gender transition
Key Trial Info
Start Date :
August 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT06015191
Start Date
August 31 2023
End Date
December 1 2027
Last Update
May 11 2025
Active Locations (1)
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1
Children's Mercy Kansas City
Kansas City, Missouri, United States, 64108