Clinical Trial

Remote Cardiac Rehab for Adolescents With Congenital Heart Disease

Study acronym: Remote-CaRe
Recruiting
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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 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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2023-08-22; most recent amendment 2026-04-28.
Status change: Not Yet Recruiting → Recruiting 2023-08-31
Trial Details
NCT Number NCT06015191
Lead Sponsor Children's Mercy Hospital Kansas City
Collaborators: University of Kansas, Children's Hospital of Philadelphia, University of North Carolina, Chapel Hill, National Heart, Lung, and Blood Institute (NHLBI)
Conditions Congenital Heart Disease in Children
Enrollment 74 participants
Start Date 2023-08-31
Primary Completion 2027-06 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-04