Influence of Physical Exercise on Endothelial Function in Pregnant Women

Study Overview
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Brief Summary
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The purpose of this study is to determine the effect of regular aerobic exercise on endothelial function in pregnancy.

Detailed Description
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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.

Official Title
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Influence of Physical Exercise on Endothelial Function in Pregnant Women: Randomized Clinical Trial

Conditions
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Pregnancy, Preeclampsia, Exercise

Intervention / Treatment
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* Behavioral: Regular aerobic physical exercise
* Behavioral: Activities of daily living


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primiparous women who have not participated in a structured exercise program, including significant amounts of walking for the past four months are eligible for the trial. Live foetus at the routine ultrasound scan and a normal pregnancy. Gestational age 16 to 20 weeks Written informed consent will be obtained from each woman prior to the inclusion in the study. Exclusion Criteria: History of high blood pressure Chronic medical illnesses (cancer, renal, endocrinologic, psychiatric, neurologic, infectious and cardiovascular diseases) Persistent bleeding after week 12 of gestation Poorly controlled thyroid disease Placenta praevia, incompetent cervix, polyhydramnios, oligohydramnios History of miscarriage in the last twelve months Diseases that could interfere with participation (following recommendations from ACSM 2000, ACOG 2003).

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br> | Behavioral: Regular aerobic physical exercise<br>* 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.<br>|
| Active Comparator: II<br> | Behavioral: Activities of daily living<br>* Basic activities of daily living (bathing, dressing, eating, walking) without counseling by a physical therapist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brachial artery flow-mediated dilation |  | Baseline, 8 weeks, 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| high sensitivity C-Reactive Protein |  | Baseline, 16 weeks | 
| Nitrates, Nitrites and cyclic GMP |  | Baseline, 16 weeks | 
| Blood lipid profile |  | Baseline, 16 weeks | 
| Anthropometric indicators |  | Baseline, 8 weeks, 16 weeks | 
| Functional capacity (VO2 Max) |  | Baseline, 8 weeks, 16 weeks | 
| Maternal and neonatal outcomes |  | At delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy, preeclampsia, exercise