Influence of Physical Exercise on Endothelial Function in Pregnant Women

This study has been completed.
Sponsor:
Collaborator:
Fundación Cardiovascular de Colombia
Information provided by:
Universidad del Valle, Colombia
ClinicalTrials.gov Identifier:
NCT00741312
First received: August 22, 2008
Last updated: January 20, 2011
Last verified: January 2011
  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 1
Phase 2

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

Resource links provided by NLM:


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

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
Study Completion Date: January 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

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

No publications provided by Universidad del Valle, Colombia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ana Cecilia Aguilar de Plata, Universidad del Valle
ClinicalTrials.gov Identifier: NCT00741312     History of Changes
Other Study ID Numbers: 182-07
Study First Received: August 22, 2008
Last Updated: January 20, 2011
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Universidad del Valle, Colombia:
pregnancy
preeclampsia
exercise

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications

ClinicalTrials.gov processed this record on April 17, 2014