NCT06015191 Remote Cardiac Rehab for Adolescents With Congenital Heart Disease

Eligibility & Interventions

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This trial targets 74 participants in total. It began in 2023-08-31 with a primary completion date of 2027-06.

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 organized athletic/exercise activity (not including school physical education class). 3. Height less than 132cm 4. Pregnancy or planned surgery or procedure (excluding outpatient, non-cardiac procedures) within the 12-week study period. 5. Meeting at least 1 exercise test safety or screening criteria on most recent exercise test (pre-study) or baseline outcomes visit exercise test 6. Presence of significant cardiac dysfunction that would impair safe participation in moderate-to-vigorous intensity exercise 7. 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 8. Uncontrolled or poorly controlled asthma 9. Presence of implanted cardioverter-defibrillator 10. Pacemaker with rate-responsive function initiated 11. Reliance on ventricular assist device 12. Prescribed milrinone medication 13. Listed for heart transplantation 14. Active engagement in hormone replacement for gender transition

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