To test the hypothesis that in formerly preeclamptic women with a low plasma volume a month physical excercise improves vascular and hemodynamic functions.
ID
Source
Brief title
Condition
- Maternal complications of pregnancy
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
improvement of plasma volume > 10%
Secondary outcome
improvement of vascular and endothelial function in response to excercise
Background summary
In the Netherlands, about 15% of all first pregnant women develop hypertensive
complications, of which preeclampsia and general seizures may be considerd to
be the most severe endpoints. In the western world, these complications account
for a substantial maternal and fetal/neonatal morbidity and mortality. Evidence
is accumulating that these disorders are superimposed upon a preexisting
hemodynamic or hemostatic risk condition. These factors negatively affect
placental and vascular functioning. Considering these premorbid riskfactors, it
is not surprising that remotely these women are more involved in hypertension,
cardiovascular disease and stroke. A central position in the circulatory
problems may arise from a relatively small venous compartement (plasma volume
compartement), affecting cardivascular reserve capacity and associated with
sympathetic overactivity, reduced arterial compliance and elevated resting
cardiac output. Clinically, a reduced plasma volume compartement is associated
with an increased risk to develop gestational hypertensive problems such as
preeclampsia and fetal growth restriction. By positively affecting this amount
of plasma volume, this may contribute to a reduction in these hypertensive
complications.
Study objective
To test the hypothesis that in formerly preeclamptic women with a low plasma
volume a month physical excercise improves vascular and hemodynamic functions.
Study design
in this pilot study we intend to include 10 women. Considering a power 90% and
a type I error 5% we will be able to detect a difference 10-12% in plasma
volume. We intend to alter the plasma volume compartement by use of a
standardised physical excercise program in which the training will be to a
maximum of 70% of that maximal reached intensity in these women. The response
to this training program will be evaluated as a function of change in
plasma volume
resting and excercise induced cardiac output
oxygen consumption during excercise
venous capacity and compliance
arterial compliance
flow mediated vasodilation
biochemical changes in VWF ag and fibronectin, hs CRP and micro-albuminuria
hemoglobin count
blood pressure and heart rate (excercise induced)
weight and lean body weight
Intervention
physical excercise; first two weeks twice a week 1 hour at max 70% of the VO2max
the last two weeks three times a week at 70% of the VO2max
Study burden and risks
The training program is in a way a life style change. The insertion of the two
venous catheters uposes a minimal dyscomfort, the protocol takes time but may
also be considerd as moderate dyscomfort. We consider the total protocol as
moderate strain, in which the life style adjustments may be considerd to be the
most meaningfull.
Geert Grooteplein 10
6500 HB Nijmegen
Nederland
Geert Grooteplein 10
6500 HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
prior history of preeclampsia
Exclusion criteria
incapability to cope with physical activity
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 | NL12203.091.06 |