Exercise Induced Improvement of the Venous Reserve Capacity in Formerly Pre-eclamptic Women
Primary Purpose
Preeclampsia
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Aerobic Exercise training
Sponsored by
About this trial
This is an interventional basic science trial for Preeclampsia focused on measuring preeclampsia, low vs high plasma volume
Eligibility Criteria
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
Sites / Locations
- Radboud University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Other
Arm Label
1
2
3
Arm Description
formerly preeclamptic women with low plasma volume
formerly preeclamptic women with normal plasma volume
Healthy controls
Outcomes
Primary Outcome Measures
Increase plasma volume
Secondary Outcome Measures
Venous Compliance
Endothelial dysfunction
Sympathetic resting activity
Splanchnic blood flow
Full Information
NCT ID
NCT00900458
First Posted
May 11, 2009
Last Updated
May 6, 2015
Sponsor
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00900458
Brief Title
Exercise Induced Improvement of the Venous Reserve Capacity in Formerly Pre-eclamptic Women
Official Title
Adjustment of the Venous Reserve Capacity by Aerobic Exercise in Women at Increased Risk of Hypertensive Pregnancy Complications
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Radboud University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
Keywords
preeclampsia, low vs high plasma volume
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
formerly preeclamptic women with low plasma volume
Arm Title
2
Arm Type
Active Comparator
Arm Description
formerly preeclamptic women with normal plasma volume
Arm Title
3
Arm Type
Other
Arm Description
Healthy controls
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exercise training
Intervention Description
aerobic exercise training (cycling)
Primary Outcome Measure Information:
Title
Increase plasma volume
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Venous Compliance
Time Frame
3 months
Title
Endothelial dysfunction
Time Frame
3 months
Title
Sympathetic resting activity
Time Frame
3 months
Title
Splanchnic blood flow
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Spaanderman, Dr
Organizational Affiliation
Radboud University Medical Center Nijmegen
Official's Role
Study Chair
Facility Information:
Facility Name
Radboud University Medical Center
City
Nijmegen
ZIP/Postal Code
6500HB
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
26351026
Citation
Scholten RR, Hopman MT, Lotgering FK, Spaanderman ME. Aerobic Exercise Training in Formerly Preeclamptic Women: Effects on Venous Reserve. Hypertension. 2015 Nov;66(5):1058-65. doi: 10.1161/HYPERTENSIONAHA.115.05786. Epub 2015 Sep 8.
Results Reference
derived
PubMed Identifier
24906915
Citation
Scholten RR, Spaanderman ME, Green DJ, Hopman MT, Thijssen DH. Retrograde shear rate in formerly preeclamptic and healthy women before and after exercise training: relationship with endothelial function. Am J Physiol Heart Circ Physiol. 2014 Aug 1;307(3):H418-25. doi: 10.1152/ajpheart.00128.2014. Epub 2014 Jun 6.
Results Reference
derived
PubMed Identifier
24769012
Citation
Scholten RR, Thijssen DJ, Lotgering FK, Hopman MT, Spaanderman ME. Cardiovascular effects of aerobic exercise training in formerly preeclamptic women and healthy parous control subjects. Am J Obstet Gynecol. 2014 Nov;211(5):516.e1-516.e11. doi: 10.1016/j.ajog.2014.04.025. Epub 2014 Apr 23.
Results Reference
derived
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Exercise Induced Improvement of the Venous Reserve Capacity in Formerly Pre-eclamptic Women
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