to study the effect of therapeutic dose of corticosteroids, administered via nasal spray and inhalation for 28 days, on strength in strength athletes and on maximal power output in cyclists.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
skeletspierstelsel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
in strength athletes: maximal strength of leg extensors (1RM) measured with
isokinetic equipment (Cybex)
in cyclists: maximal power output in an incremental cycle ergometer test
Secondary outcome
subjective perception as measured with a questionnaire scoring the POMS
(Profile of Mood State).
Background summary
Corticosteroids are on the dopinglist becaus of supposed performance enhancing
properties. Because of the broad medical indication and use of corticosteroids
many athletes need a therapeutic use exemption (TUE), which leads to enormous
burocratic burden.
Unfortunately studies about effects of corticosteroids on sport performance are
lacking and this study aims to fill that gap in knowledge.
Study objective
to study the effect of therapeutic dose of corticosteroids, administered via
nasal spray and inhalation for 28 days, on strength in strength athletes and on
maximal power output in cyclists.
Study design
20 well trained strength athletes are randomly assigned to a placebo or verum
group, and the same is done in 20 well trained cyclists.
They have to self administer a nasal spray and inhalation for 28 days. The
design is double blind, placebo controlled (no cross over).
During the intervention period the training has to be kept constant. Effect
measurements are done at the onset of the study and after 2 and 4 weeks of the
intervention.
Intervention
Daily self administration of a nasal spray and inhalation for 28 days
Study burden and risks
the subjects have to self administer a daily nasal spray and inhalation for a
period of 28 days.
They do not have to change the life style. With the therapeutic dosages and
precautions (mouth wash after administration and taking medicine before a
meal)no significant side effects are to be anticipated.
Every subject has to report to the lab three times for measuring strength or
maximal power output. Every lab visit takes maximally one hour.
postbus 616
6200 MD Maastricht
Nederland
postbus 616
6200 MD Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
male, > 18 years of age, healthy, athletically active and well trained in either strength or cycling. Training at least 4 times per week, including high intensity.
Exclusion criteria
Competing at a level where in or out of competition doping testing is possible
using corticosteroids or other medication that may interfere with the study
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2006-004277-98-NL |
| CCMO | NL13938.068.06 |