- To determine physical fitness in children with a congenital heart disease (ventricular septum defect, atrium septum defect, tetralogy of Fallot, transposition of large arteries and patients after a (modified) Fontan-operation) and to compareā¦
ID
Source
Brief title
Condition
- Congenital cardiac disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Physical fitness, examined during the incremental cycling test. In addition,
activity patterns of the children for a period of 7 days will be registered
using an activity monitor. Using these data, insight is provided into the
background of the possible differences in physical fitness and physical
characteristics between the several congenital heart diseases and between
congenital heart disease and controls.
Secondary outcome
Physical characteristics (i.e., fat percentage, body mass index, pulmonary
function) will be examined using non-invasive and not painful/harmful
procedures/techniques.
Background summary
The prevalence of congenital heart disease is ~38500 in the Netherlands alone.
Due to the improved quality of the treatment of congenital heart diseases and a
relatively low mortality rate, an increase in the prevalence of children and
adults with congenital heart diseases is present. The beneficial health effects
of physical exercise in children are frequently described. However, because of
*over-protection* and (primary or secondary) an attenuated physical capacity in
children with congenital heart disease, most of these subjects have a sedentary
life style. An importance consequence of this sedentary life style is the
marked increased risk to develop chronic diseases associated with physical
inactivity and attenuated quality of life.
Previous studies demonstrated that inactive children are more likely to remain
inactive at the adult or adolescence age. This emphasizes the importance of
promotion of an active life style, preferably at an early age. The physical
fitness level can be determined through the use of exercise tests, which can be
utilized to determine a safe range in which these subjects can be physically
active. Determining physical fitness level can help to match the level of
physical activity in daily living, sports activities and therapy with the
physical fitness of these subjects. This will eventually lead to an improvement
in the quality of life. However, to date only few studies examined the level of
physical fitness and daily activities in children with congenital heart
disease.
Study objective
- To determine physical fitness in children with a congenital heart disease
(ventricular septum defect, atrium septum defect, tetralogy of Fallot,
transposition of large arteries and patients after a (modified)
Fontan-operation) and to compare physical fitness between these groups.
- Compare physical fitness in children with a congenital heart disease (all 5
subdivision) with age-matched healthy children.
- To determine the daily activity pattern of children with a congenital heart
disease (all 5 subdivisions) and healthy age-matched children.
- Determine anthropometrical characteristics of children with a congenital
heart disease (all 5 subdivisions) and healthy age-matched children.
Study design
On Day 1, physical fitness and anthropometrical characteristics will be
examined. Subsequently, the children receive an apparatus that registers the
activities performed throughout the day. The children will be instructed to
wear with apparatus during the day for a period of 7 days. After these 7 days,
the children report to the laboratory to return the apparatus. In addition, a
second cycling test is performed to examine the physical fitness level in these
children. These results will be compared with an age-matched group of healthy
children and between the 5 included groups of congenital heart disease.
Study burden and risks
The single test that may be related to an increased risk is the incremental
(symptom limited) maximal cycling test. Since early *90-ties, this test is
performed on a regular basis as a standard procedure at the Department of
Pediatrics in children with a congenital heart disease. As such, the test will
be performed according to the standard experimental protocol as used at the
Department of pediatrics and by several other researchers in the past in this
group of children. Each test will be performed under continuous supervision of
a physician. During the test, heart rate, oxygen consumption, ventilation,
blood pressure and saturation will be registered continuously. This enables the
researcher(s) and physician(s) to evaluate the most important vital functions
to provide an accurate view of the clinical and physiological condition of the
child during performance of the test.
Geert Grooteplein-noord 21
6525 EZ Nijmegen
Nederland
Geert Grooteplein-noord 21
6525 EZ Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
- 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
Exclusion criteria
- 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)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL16342.091.07 |