Clinical trial NCT00741312: Influence of Physical Exercise on Endothelial Function in Pregnant Women
Official title: Influence of Physical Exercise on Endothelial Function in Pregnant Women: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pregnancy
Preeclampsia
Exercise
Keywords: pregnancy
preeclampsia
exercise
Lead sponsor: Universidad del Valle, Colombia
Sponsor class: OTHER
Collaborators: name: Fundación Cardiovascular de Colombia
First posted: 2008-08-26
Enrollment: 64
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Brachial artery flow-mediated dilation
timeFrame: Baseline, 8 weeks, 16 weeks
Secondary outcomes:
measure: high sensitivity C-Reactive Protein
timeFrame: Baseline, 16 weeks
measure: Nitrates, Nitrites and cyclic GMP
timeFrame: Baseline, 16 weeks
measure: Blood lipid profile
timeFrame: Baseline, 16 weeks
measure: Anthropometric indicators
timeFrame: Baseline, 8 weeks, 16 weeks
measure: Functional capacity (VO2 Max)
timeFrame: Baseline, 8 weeks, 16 weeks
measure: Maternal and neonatal outcomes
timeFrame: At delivery
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Centro de Salud Cañaveralejo
state: Valle
Study officials:
affiliation: Universidad del Valle
name: Ana C Plata, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad del Valle
name: Adalberto Sanchez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pinzon DC, Zamora K, Martinez JH, Florez-Lopez ME, de Plata AC, Mosquera M, Ramirez-Velez R. Type of delivery and gestational age is not affected by pregnant Latin-American women engaging in vigorous exercise: a secondary analysis of data from a controlled randomized trial. Rev Salud Publica (Bogota). 2012 Oct;14(5):731-43.
citation: Montoya Arizabaleta AV, Orozco Buitrago L, Aguilar de Plata AC, Mosquera Escudero M, Ramirez-Velez R. Aerobic exercise during pregnancy improves health-related quality of life: a randomised trial. J Physiother. 2010;56(4):253-8. doi: 10.1016/s1836-9553(10)70008-4.
citation: Ramirez-Velez R, Aguilar AC, Mosquera M, Garcia RG, Reyes LM, Lopez-Jaramillo P. Clinical trial to assess the effect of physical exercise on endothelial function and insulin resistance in pregnant women. Trials. 2009 Nov 17;10:104. doi: 10.1186/1745-6215-10-104.