Influence of Physical Exercise on Endothelial Function in Pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00741312
Recruitment Status : Completed
First Posted : August 26, 2008
Last Update Posted : January 21, 2011
Fundación Cardiovascular de Colombia
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Pregnancy Preeclampsia Exercise Behavioral: Regular aerobic physical exercise Behavioral: Activities of daily living Phase 1 Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Influence of Physical Exercise on Endothelial Function in Pregnant Women: Randomized Clinical Trial
Study Start Date : October 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: I Behavioral: 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.

Active Comparator: II Behavioral: Activities of daily living
Basic activities of daily living (bathing, dressing, eating, walking) without counseling by a physical therapist.

Primary Outcome Measures :
  1. Brachial artery flow-mediated dilation [ Time Frame: Baseline, 8 weeks, 16 weeks ]

Secondary Outcome Measures :
  1. high sensitivity C-Reactive Protein [ Time Frame: Baseline, 16 weeks ]
  2. Nitrates, Nitrites and cyclic GMP [ Time Frame: Baseline, 16 weeks ]
  3. Blood lipid profile [ Time Frame: Baseline, 16 weeks ]
  4. Anthropometric indicators [ Time Frame: Baseline, 8 weeks, 16 weeks ]
  5. Functional capacity (VO2 Max) [ Time Frame: Baseline, 8 weeks, 16 weeks ]
  6. Maternal and neonatal outcomes [ Time Frame: At delivery ]

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Ages Eligible for Study:   16 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00741312

Centro de Salud Cañaveralejo
Cali, Valle, Colombia
Sponsors and Collaborators
Universidad del Valle, Colombia
Fundación Cardiovascular de Colombia
Principal Investigator: Ana C Plata, MSc Universidad del Valle
Principal Investigator: Adalberto Sanchez, PhD Universidad del Valle