Exercise Induced Improvement of the Venous Reserve Capacity in Formerly Pre-eclamptic Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00900458
First received: May 11, 2009
Last updated: August 10, 2011
Last verified: May 2009

May 11, 2009
August 10, 2011
March 2009
January 2013   (final data collection date for primary outcome measure)
Increase plasma volume [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00900458 on ClinicalTrials.gov Archive Site
  • Venous Compliance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Endothelial dysfunction [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Sympathetic resting activity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Splanchnic blood flow [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Exercise Induced Improvement of the Venous Reserve Capacity in Formerly Pre-eclamptic Women
Adjustment of the Venous Reserve Capacity by Aerobic Exercise in Women at Increased Risk of Hypertensive Pregnancy Complications

Primary objective:

  • To investigate whether physical exercise prior to pregnancy in formerly preeclamptic women results in a comparable improvement of vascular and endothelial functioning as in women who had an uneventful pregnancy.

Secondary objectives:

  • Which cardiovascular and endothelial parameters are involved in the vascular adaptation to training in women with a history of preeclampsia.
  • To study the vascular adaptation in the (next) pregnancy in women with a history of preeclampsia compared with women with a history of an uncomplicated pregnancy, after improvement of their physical condition by exercise training.

This study is important in order to get a better understanding of the vascular and endothelial factors involved in preeclampsia and the effects of training on this profile. Results of this study can contribute to the improvement of preventing hypertensive complications in pregnancy and reduction of life time risk of cardiovascular disease in formerly preeclamptic women.

In the Netherlands almost 15.000 women each year develop hypertensive complications like preeclampsia during their first pregnancy. In the western world these complications account for the most substantial attribution to neonatal and maternal morbidity and mortality. The exact etiology of this disease cascade is still unknown. There is accumulating evidence that subclinical abnormalities and preexistent haemodynamic, haemostatic and endothelial factors are involved, and thought to have negative impact on placental and endothelial functioning. The same factors are found to be risk factors for cardiovascular incidents and therefore it is not surprising that remotely these women are more at risk for hypertension, cardiovascular disease and stroke. Plasma volume has possibly a central role in the disease cascade, resulting in decreased cardiovascular reserve capacity. Furthermore a low plasma volume is found to be a strong predictor for recurrence of hypertensive complicated pregnancy. Adaptation, like in pregnancy, is for a large extent depending on the functioning of the venous compartment. In formerly preeclamptic women with low plasma volume is the venous compliance and capacitance decreased, furthermore there is sympathic hyperactivity. This combination reflects a decreased cardiovascular reserve capacity. These women with low plasma volume show a reduced ability to adapt their cardiovascular system to a new pregnancy.

It is known that physical exercise increases plasma volume in healthy adults, also arterial and both venous compliance and capacitance is improved by exercise. Since abnormal circulatory functions are common in formerly preeclamptic women, we want to study the effects of exercise in this specific group, and compare these results with women after an uneventful pregnancy. In preventive perspective it would be beneficial that also formerly preeclamptic women show a circulatory adaption to aerobic exercise, possibly they could improve their haemodynamic profile prior to their pregnancy

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Preeclampsia
Behavioral: Aerobic Exercise training
aerobic exercise training (cycling)
  • Active Comparator: 1
    formerly preeclamptic women with low plasma volume
    Intervention: Behavioral: Aerobic Exercise training
  • Active Comparator: 2
    formerly preeclamptic women with normal plasma volume
    Intervention: Behavioral: Aerobic Exercise training
  • 3
    Healthy controls
    Intervention: Behavioral: Aerobic Exercise training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
June 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients: formerly preeclamptic women with history of preeclampsia (according to set criteria)
  • controls: women with history of an uneventful pregnancy All women are examined at least 5 months postpartum;

Exclusion Criteria:

  • pregnancy
  • insulin dependant diabetes mellitus
  • use of medication known to interfere with cardiovascular system
  • incapability to cope with physical exercise
  • auto immune disease
Female
18 Years to 42 Years
Yes
Contact: Ralph R Scholten, MSc +31 24 361 4906 r.scholten@obgyn.umcn.nl
Contact: Marc Spaanderman, Dr. + 31 24 361 7831 m.spaanderman@obgyn.umcn.nl
Netherlands
 
NCT00900458
exercise and pre-eclampsia
No
dr.M.E.A. Spaanderman/ drs.R.R. Scholten, Radboud University Medical Center Nijmegen
Radboud University
Not Provided
Study Chair: Marc Spaanderman, Dr Radboud University Medical Center Nijmegen
Radboud University
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP