Influence of Physical Exercise on Endothelial Function in Pregnant Women - Full Text View

Sponsors and Collaborators:	Universidad del Valle, Columbia Fundación Cardiovascular de Colombia
Information provided by:	Universidad del Valle, Columbia
ClinicalTrials.gov Identifier:	NCT00741312

Purpose

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

Condition	Intervention	Phase
Pregnancy Preeclampsia Exercise	Behavioral: Regular aerobic physical exercise Behavioral: Activities of daily living	Phase I Phase II

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Influence of Physical Exercise on Endothelial Function in Pregnant Women: Randomized Clinical Trial

Further study details as provided by Universidad del Valle, Columbia:

Primary Outcome Measures:

Brachial artery flow-mediated dilation [ Time Frame: Baseline, 8 weeks, 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

high sensitivity C-Reactive Protein [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: No ]
Nitrates, Nitrites and cyclic GMP [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: No ]
Blood lipid profile [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: No ]
Anthropometric indicators [ Time Frame: Baseline, 8 weeks, 16 weeks ] [ Designated as safety issue: No ]
Functional capacity (VO2 Max) [ Time Frame: Baseline, 8 weeks, 16 weeks ] [ Designated as safety issue: No ]
Maternal and neonatal outcomes [ Time Frame: At delivery ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	64
Study Start Date:	October 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

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

Arms

Assigned Interventions

I: Experimental

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.

II: Active Comparator

Behavioral: Activities of daily living

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

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

Ages Eligible for Study:	16 Years to 30 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741312

Contacts

Contact: Ana C Plata, MSc

+57 2 5185603

caplata@univalle.edu.co

Locations

Colombia, Valle
Centro de Salud Cañaveralejo	Recruiting
Cali, Valle, Colombia
Contact: Gonzalo Loboa, OD, MSc. +57 2 6080124
Principal Investigator: Ana C Plata, MSc
Principal Investigator: Adalberto Sanchez, PhD
Sub-Investigator: Elena Konovalova, PhD
Sub-Investigator: Patricio Lopez-Jaramillo, PhD
Sub-Investigator: Beatriz Gracia, MPH
Sub-Investigator: Robinson Ramirez, PT, PhD (s)

Sponsors and Collaborators

Universidad del Valle, Columbia

Fundación Cardiovascular de Colombia

Investigators

Principal Investigator:	Ana C Plata, MSc	Universidad del Valle
Principal Investigator:	Adalberto Sanchez, PhD	Universidad del Valle

More Information

Responsible Party:	Universidad del Valle ( Ana Cecilia Aguilar de Plata )
Study ID Numbers:	182-07
Study First Received:	August 22, 2008
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00741312
Health Authority:	Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Universidad del Valle, Columbia:

pregnancy
preeclampsia
exercise

Study placed in the following topic categories:

Hypertension, Pregnancy-Induced
Pregnancy Complications
Eclampsia
Pregnancy toxemia /hypertension

Pre-Eclampsia
Preeclampsia
Hypertension

ClinicalTrials.gov processed this record on January 16, 2009