Primary: 1. To determine what the effect of exercise on coagulation.2. Establish the changes in bloodcell counts as a result of exercise.3. What the effect of exercise is on the platelet function.4. To test the different effects of cycling and…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Changes in hematological parameters between pre and post exercise
• Changes in coagulation between pre and post exercise.
• Pre and Post exercise changes in platelet function and activity.
• Difference between the effect, of cycling and running on the test parameters
Secondary outcome
n.v.t
Background summary
Endofibrosis is a disease that occurs in 15-20% of the professional cyclist.
It's characterized by fibrosis of the iliacal arterie, the consequence is a
thickening of the artery vessel wall and narrowing of the intima. Which
results in a reduced blood flow to the leg.
It's a irreversible disease which can only be treated with an operation.
Although in 1/3 of all cases, the treatment does not result in a foreseen
outcome.
So far it's still unknown what causes endofibrosis. A small pelvic angle, which
arises during cycling because of the sitting position, and changes in blood
flow are recommended as important determinants. Moreover it's known that
exercise can activate the coagulation, which can have an effect on some
celtypes in the vessel wall.
Study objective
Primary:
1. To determine what the effect of exercise on coagulation.
2. Establish the changes in bloodcell counts as a result of exercise.
3. What the effect of exercise is on the platelet function.
4. To test the different effects of cycling and running on the test parameters.
Secondary:
1. To determine the underlaying mechanism of possible changes in coagulation
and platelet function after exercise.
2. To investigate the relation between coagulation and endofibrosis in cycling.
Study design
10 o'clock in the morning, blood will be collected from the cyclists for
determination of haemostatic and haemotological parameters. After a normal
intensive training of 4 hours, blood will be collected.
The runners will undergo the same protocol, only the training for the runners
will be 1.5 hours
Intervention
The training for the cyclists will be 4 hour training in the Ardennes, with
intensive moments on the hills. For the group runners the training will be 1.5
hour training on 80-85% of maximal heart frequency.
For both groups blood will be collected right before and after exercise.
Study burden and risks
The risks for the participants of the study are the same as at a normal vena
punction, this is haematoma and bleeding at the spot of punction. Furthermore
the training equal a normal training on for this group, so no higher risk is
expected.
The burden and risks associated with participation are ethical responsible.
Universiteitssingel 50
Maastricht 6229ER
NL
Universiteitssingel 50
Maastricht 6229ER
NL
Listed location countries
Age
Inclusion criteria
Population cyclists:
- minimal 18 years old and max 35 years old
- mentally capable
- train 3 times a week or more at the level of nation competition or higher;Population runners:
- minimal 18 years old and maximal 35.
- mentally capable
- train 3 times a week or more.
Exclusion criteria
- diagnosed with coagulation or platelet function disorder
- uses medication against coagulation or platelets
- vascular surgery in the past 6 months
- BMI >30
- using of doping
- 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
In other registers
| Register | ID |
|---|---|
| Other | 3846 |
| CCMO | NL42855.068.12 |
| OMON | NL-OMON20436 |