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Completed

NCT Number: NCT00741312

Influence of Physical Exercise on Endothelial Function in Pregnant Women

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

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Key information

Age range

16 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Centro de Salud Cañaveralejo

Cali, Valle del Cauca Department, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Regular aerobic physical exercise

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.

Activities of daily living

Behavioral

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

Primary outcomes

  1. Brachial artery flow-mediated dilation

    Time frame: Baseline, 8 weeks, 16 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidad del Valle, Colombia

Other

Collaborators

  • Fundación Cardiovascular de Colombia

Registry information

Official study title

Influence of Physical Exercise on Endothelial Function in Pregnant Women: Randomized Clinical Trial

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Aug 26, 2008
Registry last updated
Jan 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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