Influence of Physical Exercise on Endothelial Function in Pregnant Women
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|ClinicalTrials.gov Identifier: NCT00741312|
Recruitment Status : Completed
First Posted : August 26, 2008
Last Update Posted : January 21, 2011
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Preeclampsia Exercise||Behavioral: Regular aerobic physical exercise Behavioral: Activities of daily living||Phase 1 Phase 2|
Preeclampsia is a common maternal disease that complicates 5% to 10% of pregnancies and remains as the major cause of maternal and neonatal mortality, especially in developing countries. Cost-effective interventions aimed to prevent the development of preeclampsia are urgently needed. Ethiopathogenesis of preeclampsia involves multiple mechanisms as oxidative stress, endothelial dysfunction, infections, maternal constitutional factors, and others. Regular aerobic exercise recovers endothelial function, decreases oxidative stress and improves maternal constitutional factors.
The purpose of this Controlled Clinical Trial is to determine the effect of regular aerobic exercise on endothelium-dependent brachial artery flow-mediated dilatation. Furthermore, the effect of exercise on biomarkers on vascular function and perinatal outcomes will be evaluated.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Influence of Physical Exercise on Endothelial Function in Pregnant Women: Randomized Clinical Trial|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||January 2011|
Behavioral: Regular aerobic physical exercise
Walking (10 minutes), aerobic exercise (30 minutes), stretching (10 minutes) and relaxation exercise (10 minutes). Exercise will be performed at three sessions per week. All sessions will be supervised by a physical therapist and a physical educator.
The exercise-program follows the ACOG and ACSM exercise prescription. Aerobic activities will be performed at moderate intensity (60-70% of maximal heart rate) measured by the 6-20 Borg's rating scale. Each session starts with a 5 minutes of warm up, followed by 30 minutes of aerobic activity, including 5 minutes cool down. This is followed by 15 minutes of circuit strength training of the upper limbs, lower limbs, and deep abdominal stabilization muscles. The last 5 minutes consists of stretching and relaxation exercises.
|Active Comparator: II||
Behavioral: Activities of daily living
Basic activities of daily living (bathing, dressing, eating, walking) without counseling by a physical therapist.
- Brachial artery flow-mediated dilation [ Time Frame: Baseline, 8 weeks, 16 weeks ]
- high sensitivity C-Reactive Protein [ Time Frame: Baseline, 16 weeks ]
- Nitrates, Nitrites and cyclic GMP [ Time Frame: Baseline, 16 weeks ]
- Blood lipid profile [ Time Frame: Baseline, 16 weeks ]
- Anthropometric indicators [ Time Frame: Baseline, 8 weeks, 16 weeks ]
- Functional capacity (VO2 Max) [ Time Frame: Baseline, 8 weeks, 16 weeks ]
- Maternal and neonatal outcomes [ Time Frame: At delivery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00741312
|Centro de Salud Cañaveralejo|
|Cali, Valle, Colombia|
|Principal Investigator:||Ana C Plata, MSc||Universidad del Valle|
|Principal Investigator:||Adalberto Sanchez, PhD||Universidad del Valle|