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Influence of Physical Exercise on Endothelial Function in Pregnant Women

U

Universidad del Valle, Colombia

Status and phase

Completed
Phase 2
Phase 1

Conditions

Preeclampsia
Exercise
Pregnancy

Treatments

Behavioral: Regular aerobic physical exercise
Behavioral: Activities of daily living

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

64 estimated patients

Sex

Female

Ages

16 to 30 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

64 participants in 2 patient groups

I
Experimental group
Treatment:
Behavioral: Regular aerobic physical exercise
II
Active Comparator group
Treatment:
Behavioral: Activities of daily living

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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