Influence of Physical Exercise on Endothelial Function in Pregnant Women

Phase 1

Completed

• Conditions: Pregnancy; Preeclampsia; Exercise

• Registration Number: NCT00741312
• Lead Sponsor: Universidad del Valle, Colombia

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2008-08-22
• Study First Submitted QC: 2008-08-22
• Study First Posted: 2008-08-26
• Study Start: 2008-10
• Primary Completion: 2010-10
• Status Verified: 2011-01
• Study Completion: 2011-01
• Last Update Submitted: 2011-01-20
• Last Update Posted: 2011-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Brachial artery flow-mediated dilation	Baseline, 8 weeks, 16 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centro de Salud Cañaveralejo; 🇨🇴 Cali, Valle, Colombia