Influence of Physical Exercise on Endothelial Function in Pregnant Women

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00741312
• Other study ID #: 182-07
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 22, 2008
• Last updated: January 20, 2011
• Start date: October 2008
• Est. completion date: January 2011

Study information

• Verified date: January 2011
• Source: Universidad del Valle, Colombia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 30 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Exercise
• Pre-Eclampsia
• Preeclampsia
• Pregnancy

Intervention

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

Locations

Country	Name	City	State
Colombia	Centro de Salud Cañaveralejo	Cali	Valle

Sponsors (2)

Lead Sponsor	Collaborator
Universidad del Valle, Colombia	Fundación Cardiovascular de Colombia

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brachial artery flow-mediated dilation		Baseline, 8 weeks, 16 weeks	No
Secondary	high sensitivity C-Reactive Protein		Baseline, 16 weeks	No
Secondary	Nitrates, Nitrites and cyclic GMP		Baseline, 16 weeks	No
Secondary	Blood lipid profile		Baseline, 16 weeks	No
Secondary	Anthropometric indicators		Baseline, 8 weeks, 16 weeks	No
Secondary	Functional capacity (VO2 Max)		Baseline, 8 weeks, 16 weeks	No
Secondary	Maternal and neonatal outcomes		At delivery	Yes