Remote Cardiac Rehab for Adolescents With Congenital Heart Disease

Launched by CHILDREN'S MERCY HOSPITAL KANSAS CITY · Aug 22, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how effective video conferencing can be for helping teenagers with congenital heart disease (CHD) exercise from home. The study will involve young people aged 12 to 19 who have been diagnosed with specific types of CHD. Participants will be divided into two groups: one group will take part in live, group exercise sessions led by a health coach through video calls three times a week for 12 weeks, while the other group will receive informational materials about exercise but won't participate in live sessions. The main goal is to see how these two groups change in their fitness levels over time.

To be eligible for the trial, participants need to be between 12 and 19 years old, diagnosed with one of the specified heart conditions, and have a doctor’s approval to exercise. They should also have access to the internet and be available for the exercise sessions in the evenings during the week. This study could be a great opportunity for young people to improve their health while connecting with others, all from the comfort of their own home!

Gender

ALL

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