To analyze the additional benefits of nebulization with a solution of NaCl or salbutamol after exercise by elite skaters in dry air in comparison to elite skaters not nebulising (controls).
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reduced decrease in FEV1 after exercise by the verum group compared to placebo
and control groups among elite skaters.
Secondary outcome
-Analyze the change in exercise induced increase of airway resistance, measured
with the FOT, after five minutes of treatment with salbutamol, 0.9% NaCl and
controls.
-Analyze the change in exercise induced decrease of airway reactance, measured
with the FOT, after five minutes of treatment with salbutamol, 0.9% NaCl and
controls.
-Analyzing the change in the electro physiological activity of the respiratory
muscle system, measured with EMG after five minutes of treatment with
Salbutamol ,isotonic saline and controls.
Background summary
Elite skaters perform in cold air, an environment which has a low absolute
humidity. In training and during competition, when the level of exertion is
high, the skater repeatedly breathes cold and dry air, resulting in an
inflammation of the lungs similar to that seen in asthma. This inflammation may
cause bronchus obstruction after exercise. In order to combat the consequences
of performing in dry or unconditioned air, this research makes use of a fully
portable ultrasonic nebulizer (OMRON).
Study objective
To analyze the additional benefits of nebulization with a solution of NaCl or
salbutamol after exercise by elite skaters in dry air in comparison to elite
skaters not nebulising (controls).
Study design
Double blind, randomized, placebo-controlled design.
Intervention
Nebulization with 1 mg Salbutamol by means of ultrasonic nebulization after
speedskating a distance of 1500 metres. Placebo group nebulization with 0.9%
sodium chloride (NaCl); the control group will only complete the 1500 metres.
Study burden and risks
The participants will undergo a lung function test once before and three times
after speedskating a distance of 1500 metres. The test consists of FOT and
spirometric measurements. Further electromyographic measurements(EMG) take
place during and after exercise. These measurements give information on muscle
activity of the respiratory muscle system. The 1500 metres speedskating lasts
approximately 3 minutes. Nebulization of salbutamol or 0.9% NaCl presents a
minimal risk and is standard practice in the study population. The potential
obstruction of the airways which may develop after a distance of 1500 metres in
dry air can be compared with previous experiences with similar exertion by
elite skaters.
Thialfweg 44
Heerenveen 8441 PW
NL
Thialfweg 44
Heerenveen 8441 PW
NL
Listed location countries
Age
Inclusion criteria
Age between 18 and 35 years.;Elite speedskater.;Women: 1500 meter time below 2:10:00 minutes.
Men: 1500 meter time below 02:05:00 minutes.
These times should have been skated within a period of two months prior to study measurement.;Able to undergo reproducible lung function tests. Three-fold repetition of FEV1 measurements, with a mutual difference of maximal 5 percent.
Exclusion criteria
Ultrasonic nebulization with Isotonic saline or tap water within 48 hours before testing.;FEV1 <70%.;Respiratory infection within 6 weeks prior to examination for which medication should be prescribed.;Use of short acting beta agonists 8 hours before testing.;Use of long acting beta agonists 24 hours before testing.;Use of leukotrineantagonists 36 hours before testing.
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 | EUCTR2012-003600-12-NL |
| ClinicalTrials.gov | NCT3550 |
| CCMO | NL41709.099.12 |