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Behavioral Intervention

Remote Cardiac Rehabilitation for Congenital Heart Disease (Remote-CaRe Trial)

N/A

Recruiting

Led By David A White, PhD

Research Sponsored by Children's Mercy Hospital Kansas City

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 12-19 years old

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

Must not have

Height less than 132cm

Presence of significant cardiac dysfunction that would impair safe participation in moderate-to-vigorous intensity exercise

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 12-weeks and change from 12-weeks to 6-months post intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effectiveness of remote cardiac rehab (at home, supervised via video) vs. handouts on exercise for adolescents with CHD, to see if it improves cardiorespiratory fitness, cardiac function, and physical frailty.

Who is the study for?

Adolescents aged 12-19 with specific congenital heart diseases, internet access at home, and cleared for exercise by their cardiologist. They must be available for in-home exercises during weekdays and not have conditions like uncontrolled asthma or reliance on a pacemaker.

What is being tested?

The trial tests if remote cardiac rehab via video conferencing is effective for adolescents with CHD. It compares live-supervised home exercise to an active control group receiving health handouts, measuring changes in fitness, heart function, body mass, and frailty over 12 weeks.

What are the potential side effects?

Since the intervention involves physical exercise supervised remotely, potential side effects may include typical risks associated with physical activity such as muscle strain or fatigue. Specific risks related to participants' heart conditions will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 19 years old.

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I have a specific type of congenital heart disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am shorter than 132cm.

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I have a heart condition that makes intense exercise unsafe for me.

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My heart's function has worsened or changed recently according to my latest echo.

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My asthma is not well-managed.

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I am currently taking milrinone.

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I cannot do physical tests or engage in intense physical activity due to my condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 12-weeks and change from 12-weeks to 6-months post intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 12-weeks and change from 12-weeks to 6-months post intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 12-weeks and change from 12-weeks to 6-months post intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Peak Cardiorespiratory Fitness

Secondary study objectives

Echocardiogram with global longitudinal strain (Fontan)

Echocardiogram with global longitudinal strain (Tetralogy of Fallot and d-transposition of the great vessels)

Exercise session adherence (Remote Cardiac Rehab Group)

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Remote Cardiac RehabilitationExperimental Treatment1 Intervention

Following a 2-week ramp-up period, participants will attend group exercise sessions, remotely delivered in their homes, 3 days per week for 45-minutes over 12-weeks led by a live-interactive health coach. There are 4 exercise session types with different modalities: Session A: 75% aerobic, 25% resistance; Session B: 25% aerobic, 75% resistance; Session C: 50% aerobic, 50% resistance; and Session D: Exercise games (mix of modalities). Each participant will rotate through a 5-week set of exercise sessions (20 sessions) twice over the 10-weeks of group exercise period.

Group II: Active ControlActive Control1 Intervention

Participants will receive a handout describing physical activities appropriate for their congenital heart disease diagnosis and providing recommendations consistent with the physical activity recommendations for children and adolescents.

0 / 8Eligibility criteria met