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Behavioural Intervention

High Intensity Interval Training for Congenital Heart Disease

N/A

Recruiting

Led By Michael Khoury, MD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

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

Must have

Children and adolescents aged 10-18 years

Repaired moderate-complex congenital heart disease

Must not have

New York Heart Association class II or worse symptoms

Cognitive impairment limiting the communication needed for the HIIT program

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effects of a home-based high intensity interval training program on exercise capacity in adolescents with repaired congenital heart disease.

Who is the study for?

This trial is for children and teens aged 10-18 with repaired moderate-complex congenital heart disease. They must speak English, have space at home for the MedBIKE system, and not be restricted from exercising by their cardiologist. Those with severe symptoms, cognitive impairments affecting communication, or recent serious arrhythmias cannot participate.

What is being tested?

The study tests a home-based high-intensity interval training (HIIT) program using a telemedicine-equipped video game-linked cycle ergometer called MedBIKE™. It aims to improve exercise capacity in youth with congenital heart disease through this novel cardiac rehabilitation approach.

What are the potential side effects?

While specific side effects are not listed, HIIT programs can generally cause increased heart rate during exercise, fatigue afterwards, muscle soreness and may pose risks if there's an underlying health condition that hasn't been adequately assessed.

Eligibility Criteria

Inclusion Criteria

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

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I am between 10 and 18 years old.

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I had surgery to fix a moderate to complex heart defect.

Exclusion Criteria

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

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My heart condition limits my physical activity.

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I have difficulty communicating which may affect my participation in the HIIT program.

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I have a heart or birth defect that limits my ability to exercise.

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I have experienced chest pain when I exert myself.

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I have not had serious heart rhythm problems in the last year.

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My oxygen levels are often below 85% without support.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1-week post-intervention, 6-months post-intervention, 12-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

Exercise capacity in the change in VO2peak (mL/kg/min) measured through CPET testing

Secondary study objectives

Changes in Health-Related Quality of Life as measured using the TNO AZL Children's Quality of Life (TACQOL) questionnaire.

Changes in endothelial function to determine arterial volume will be measured using an EndoPAT 2000 instrument.

Changes in physical activity, defined as time spent in moderate to vigorous physical activity (MVPA) and sedentary time, measured by wearing an accelerometer for 7-days prior and 7-days post MedBIKE intervention

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