No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
12 – 19
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
74 (estimated)
Sponsor
Children's Mercy Hospital Kansas City · Other
Who this trial is looking for
This trial is looking for teenagers aged 12 to 19 with congenital heart disease. Participants will join live exercise sessions at home for 45 minutes, 3 days a week, over 12 weeks, supervised by a health coach through video calls.
Are You a Good Fit for This Trial?
You may be able to join if
I am aged 12 to 19 years old.
I have been diagnosed with a congenital heart disease.
I have a doctor's approval to exercise.
I have internet access at home.
I can exercise at home between 4-7pm on at least 3 days a week.
I speak English.
I can put in maximum effort during an exercise test.
You may not be able to join if
I cannot physically or developmentally participate in exercise.
I have been active in more than 15 MET-hours of organized exercise each week.
I am shorter than 132cm.
I am currently pregnant or planning surgery in the next 12 weeks.
I have safety concerns based on my last exercise test.
I have significant heart dysfunction that affects my ability to exercise safely.
I have uncontrolled asthma.
I have an implanted cardioverter-defibrillator.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 partici…
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.
Trial Locations
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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 Car…
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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