Remote cardiac rehabilitation for adolescents with congenital heart disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.