Influence of Physical Exercise on Endothelial Function in Pregnant Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-01-31

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.

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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.

Conditions

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Pregnancy Preeclampsia Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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I

Group Type EXPERIMENTAL

Regular aerobic physical exercise

Intervention Type BEHAVIORAL

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.

II

Group Type ACTIVE_COMPARATOR

Activities of daily living

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Activities of daily living

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

Intervention Type BEHAVIORAL

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).

Minimum Eligible Age

16 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes