Start-to-Sport - Home-based Exercise for Adolescents and Adults With Congenital Heart Disease

Study Overview
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Brief Summary
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Almost 1% of all baby's is born with a heart defect (CHD) and most of them survive. Even though outcomes are good, they need lifelong follow-up because of a higher risk for cardiovascular diseases. Studies have shown that patients with CHD are not active enough and that a substantial amount of patients is overweight. Hence preventive strategies and education should not only focus on the heart problem, but also on a healthy lifestyle including physical activity. Recently a new guideline introduced exercise prescription based on the absence/presence of certain key elements. However, a number of important questions remain that preclude implementation in clinical practice. Therefore a 'Start-to-Sport' program for adults with CHD, based on this new guideline, will be investigated. This study is a randomized controlled trial that investigates the effects of the program on daily physical activity, exercise capacity, quality of life and exercise self-efficacy both in short (12 weeks) and long (52 weeks) term, along with possible mechanisms for the training effects by using a new exercise-testing protocol that looks simultaneously to all body parts that are involved during exercise. Ultimately, our findings will result in the implementation of the guideline in clinical practice.

Official Title
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Start-to-Sport - Feasibility and Efficacy of Individualized, Telemonitored, Home-based Exercise for Adolescents and Adults With Congenital Heart Disease

Conditions
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Congenital Heart Defect

Intervention / Treatment
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* Behavioral: home-based exercise training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adolescents and adults with congenital heart disease 16 to 65 years Exclusion Criteria: congenital rhythm or conduction disorders isolated congenital coronary artery anomalies pregnancy being listed for heart transplantation inability to perform standard physical activities due to mental/physical disability.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: home-based exercise training<br> | Behavioral: home-based exercise training<br>* During a 30 minute face-to-face motivational interview with an exercise specialist, the patient will be advised and coached about his exercise prescription, on how to implement it in his own daily life and on how to prevent relapse. Furthermore, the patients will receive instructions on how to monitor their exercise intensity and on recognizing adverse signals. During the following 12 weeks, patients will be asked to exercise 4.5 hours per week within the prescribed exercise intensity range according to the guidelines.<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peak oxygen uptake |  | baseline, post-intervention, after 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical activity | Physical activity will be assessed by means of the Sensewear mini armband. The patient will be asked to wear the device day and night during 1 week, while also taking notes of the physical activities undertaken by means of a logbook. | baseline, post-intervention and after 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult congenital heart disease, exercise capacity, exercise training, physical activity