In this pilot study we want to determine if a standardized cyclic ergometer test result sin a measurable and reproducible cortisol response.
ID
Source
Brief title
Condition
- Adrenal gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameter is the salivary cortisol response (salivary cortisol
value after the test - salivary cortisol value before the test)
Secondary outcome
not applicable
Background summary
Determination of salivary cortisol has emerged as a reliable alternative to
screen for HPA axis suppression, with the advantage to be very child-friendly,
cheap and easy to perform. However, assessment of basal cortisol values does
not inform us about adrenal function during stress. Recent studies have
demonstrated that salivary cortisol is well correlated to plasma cortisol
during an ACTH test in children with adrenal insufficiency. Stress due to
physical exercise results in a physiological rise of cortisol. It is not known
whether a standardized cyclic ergometer test results in a measurable
cortisolreponse.
Study objective
In this pilot study we want to determine if a standardized cyclic ergometer
test result sin a measurable and reproducible cortisol response.
Study design
The children will perform a physical working capacity test (PWC 170) under
guidance of a phyisotherapist. This is a standardized cyclic ergometer test.
Children will start cycling with a resitance of 25 watt during 3 minutes.
Subsequently, the resistance will be increased with 20 watt every 3 minutes
until the heartrate reaches 170 beats per minute. After a minumum of 1 week the
test will be repeated to determine the reproducibilaty of the test.
Intervention
submaximal standardized cyclic ergometer test
Study burden and risks
In daily life children constantly perform submaximal exercise while playing
outside and while playing sports. We therefore feel that is justified tot let
the children perform this submaximal cyclic ergometer test
Henri Dunantweg 2
8934 AD
Nederland
Henri Dunantweg 2
8934 AD
Nederland
Listed location countries
Age
Inclusion criteria
prepuberal,
children who do not use any formulation containing steroids or medication known to affect steroidmetabolism.
Exclusion criteria
a physical condition or underlying disease that does not allow submaximal exercise
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 | NL28491.000.09 |