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Exercise Training in Grown-Up Congenital Heart Disease.

Completed
Conditions
congenital heart disease
10082206
10007510
Registration Number
NL-OMON46945
Lead Sponsor
Cardiologie
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
100
Inclusion Criteria

Age >= 18 years
Congenital heart disease
NYHA Class II or III

Exclusion Criteria

Inability to give informed consent
Inability to participate in an exercise training program
Exercise-induced arrhythmia and/or ischemia
Cyanosis at rest
Pregnancy
Major cardiovascular event and/or procedure within three months previous to inclusion.
Participation in interventional clinical trial

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary outcome is the change in V*O2peak between patients in the sports<br /><br>participation group, and the control group. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary outcome measures are change in NYHA functional class, quality of<br /><br>life, and NT-proBNP levels.<br /><br><br /><br>The primary safety outcome is the composite of all hospitalizations, and all<br /><br>deaths during, or within three hours after exercise. The secondary safety<br /><br>outcome is the composite of all exercise related injuries for which medical<br /><br>attention is sought.</p><br>
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