The aim of the study is to determine the variotion in measurments of extracellular fluid of the arm using the L-Dex U400 during different measurement conditions in healthy subjects.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
gezonde proefpersonen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is variation in measurement results using the L-Dex U400.
Secondary outcome
Not applicable
Background summary
The L-Dex U400 bio-impedance measuring device which is applied to determin
extracellulair fluidr in an extremity. The reliability of the L-Dex U400 under
different measurmen conditions, for example different measuring sessions or
different observers has not been investigated. Additionally the amount of
variation in measurement results due to different conditions has not been
determined. Differences in outcomes in patients suffering form early lymph
edema (extracellular fluid) cannot be interpreted correctly. Differences could
caused by changes in the amount of extracellular fluid, but also by lack of
precision in the L-Dex U400. Therefore we want to determine first in healthy
subjects what the variation in measurement results obtained with the L-Dex U400
is under different conditions.
Study objective
The aim of the study is to determine the variotion in measurments of
extracellular fluid of the arm using the L-Dex U400 during different
measurement conditions in healthy subjects.
Study design
The study has a repeated measuremt design.
Measurments (in total 12) wil be performed: a baseline measurement, after a
short rest (10 min.), drinking coffee (200ml), change electrodes (another
observer) and after moderate exercise (30 minute cycling on a home trainer,50
Watts, 50-60 RPM) and after a final short rest period. In the next measurement
session, a week later, the same measurement protocol wil be repeated.
Study burden and risks
The burden to participate is low. The participants have to cycle for 30
minutes 50 Watts, corresponding to cycling to school and/ or work. There are no
risks associated with participation.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
Healthy subjects
Age between 18 and 25 years
Par-Questionnaire negative
Informed Consent is signed
Able to attend a measurement session on two days
Exclusion criteria
Not able to attend two measurementsessions
Heart, liver or kidney disorders
Pregnancy
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 | NL44871.042.13 |