Influence of Physical Exercise on Endothelial Function in Pregnant Women

Universidad del Valle, Colombia64 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Pregnancy Preeclampsia Exercise

Interventions

Regular aerobic physical exerciseBEHAVIORAL

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.

Activities of daily livingBEHAVIORAL

Basic activities of daily living (bathing, dressing, eating, walking) without counseling by a physical therapist.

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Centro de Salud Cañaveralejo

Cali, Valle del Cauca Department, Colombia

Outcomes

Primary Outcomes

Brachial artery flow-mediated dilation

Time frame: Baseline, 8 weeks, 16 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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