Remote cardiac rehabilitation for adolescents with congenital heart disease
Remotely Delivered Cardiac Rehabilitation for Adolescents With Congenital Heart Disease
This study is testing if live, home-based exercise sessions over video can help teenagers with congenital heart disease improve their heart health and fitness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 12 Years to 19 Years |
| Sex | All |
| Sponsor | Children's Mercy Hospital Kansas City Academic / other |
| Locations | 1 site (Kansas City, Missouri) |
| Trial ID | NCT06015191 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial aims to assess the effectiveness of live, home-based cardiac rehabilitation exercise training delivered via video conferencing for adolescents with congenital heart disease. Participants aged 12-19 will be randomly assigned to either a remote cardiac rehab group, which engages in supervised exercise sessions three times a week for 12 weeks, or an active control group receiving informational handouts. The primary focus is to measure improvements in cardiorespiratory fitness, while secondary outcomes include cardiac function and lean body mass. The intervention is designed to be interactive, allowing participants to engage with a health coach and peers during sessions.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12-19 with specific congenital heart disease diagnoses and who have received cardiology clearance for exercise.
Not a fit: Patients who are physically or developmentally unable to participate in moderate-to-vigorous physical activity may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance physical fitness and overall health outcomes for adolescents with congenital heart disease.
How similar studies have performed: Previous studies have shown promise in telehealth approaches for cardiac rehabilitation, indicating potential success for this novel application in adolescents.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kansas City, Missouri
- Children's Mercy Kansas City — Kansas City, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: David A White, PhD — Children's Mercy Kansas City
- Study coordinator: Madeline Donnelli, BS
- Email: Remotecare@cmh.edu
- Phone: 816-764-5605
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.