Physical fitness and daily activities of children with congenital heart disease.
- Conditions
- congenital heart diseaseheart disease in children10010394
- Registration Number
- NL-OMON30800
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 120
- aged between 8 and 17 years
- congenital cardiac disease (ventricular septum defect (VSD), atrium septum defect (ASD), Tetralogy of Fallot (TF), transposition large arteries (TLA), patients after the (modified) Fontan-operation)
- signed informed consent
- exept the congenital heart disease, no other pathologies
- metabolic, neurologic, muscular of orthopedic pathology/malformation
- syndromes in which congenital heart disease is only 1 of the symptoms
- decompensatio cordis (NYHA-class I-IV)
- cyanosis (baseline saturation <90%)
- tachycardia/bradycardia
- acute illness/disease (such as viral infections)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Physical fitness, examined during the incremental cycling test. In addition,<br /><br>activity patterns of the children for a period of 7 days will be registered<br /><br>using an activity monitor. Using these data, insight is provided into the<br /><br>background of the possible differences in physical fitness and physical<br /><br>characteristics between the several congenital heart diseases and between<br /><br>congenital heart disease and controls.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Physical characteristics (i.e., fat percentage, body mass index, pulmonary<br /><br>function) will be examined using non-invasive and not painful/harmful<br /><br>procedures/techniques.</p><br>