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RecruitingNCT06015191

Remote Cardiac Rehab for Adolescents With Congenital Heart Disease

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Trial Parameters

ConditionCongenital Heart Disease in Children
SponsorChildren's Mercy Hospital Kansas City
Study TypeINTERVENTIONAL
PhaseN/A
Enrollment74
SexALL
Min Age12 Years
Max Age19 Years
Start Date2023-08-31
Completion2027-06
Interventions
Remote Cardiac RehabilitationActive Control

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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 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.

Eligibility Criteria

Inclusion Criteria: 1. Age 12-19 years old 2. Male or Female 3. 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 4. Primary Cardiology clearance for exercise participation 5. Internet access in their homes 6. Available for in-home exercise between 4-7pm on at least 3 days of the Monday-Friday work week 7. English Speaking 8. 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 Criteria: 1. Physically or developmentally unable to perform outcomes assessments or participate in moderate-to-vigorous intensity physical activity 2. Participating in \> 15 MET-hours per week (mean weekly average over the past 12-months) of organiz

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