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Influence of Physical Exercise on Endothelial Function in Pregnant Women

Primary Purpose

Pregnancy, Preeclampsia, Exercise

Status
Completed
Phase
Phase 1
Locations
Colombia
Study Type
Interventional
Intervention
Regular aerobic physical exercise
Activities of daily living
Sponsored by
Universidad del Valle, Colombia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pregnancy focused on measuring pregnancy, preeclampsia, exercise

Eligibility Criteria

16 Years - 30 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

  • Centro de Salud Cañaveralejo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

I

II

Arm Description

Outcomes

Primary Outcome Measures

Brachial artery flow-mediated dilation

Secondary Outcome Measures

high sensitivity C-Reactive Protein
Nitrates, Nitrites and cyclic GMP
Blood lipid profile
Anthropometric indicators
Functional capacity (VO2 Max)
Maternal and neonatal outcomes

Full Information

First Posted
August 22, 2008
Last Updated
January 20, 2011
Sponsor
Universidad del Valle, Colombia
Collaborators
Fundación Cardiovascular de Colombia
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1. Study Identification

Unique Protocol Identification Number
NCT00741312
Brief Title
Influence of Physical Exercise on Endothelial Function in Pregnant Women
Official Title
Influence of Physical Exercise on Endothelial Function in Pregnant Women: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Universidad del Valle, Colombia
Collaborators
Fundación Cardiovascular de Colombia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Preeclampsia, Exercise
Keywords
pregnancy, preeclampsia, exercise

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Arm Title
II
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Regular aerobic physical exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Activities of daily living
Intervention Description
Basic activities of daily living (bathing, dressing, eating, walking) without counseling by a physical therapist.
Primary Outcome Measure Information:
Title
Brachial artery flow-mediated dilation
Time Frame
Baseline, 8 weeks, 16 weeks
Secondary Outcome Measure Information:
Title
high sensitivity C-Reactive Protein
Time Frame
Baseline, 16 weeks
Title
Nitrates, Nitrites and cyclic GMP
Time Frame
Baseline, 16 weeks
Title
Blood lipid profile
Time Frame
Baseline, 16 weeks
Title
Anthropometric indicators
Time Frame
Baseline, 8 weeks, 16 weeks
Title
Functional capacity (VO2 Max)
Time Frame
Baseline, 8 weeks, 16 weeks
Title
Maternal and neonatal outcomes
Time Frame
At delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana C Plata, MSc
Organizational Affiliation
Universidad del Valle
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adalberto Sanchez, PhD
Organizational Affiliation
Universidad del Valle
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Salud Cañaveralejo
City
Cali
State/Province
Valle
Country
Colombia

12. IPD Sharing Statement

Citations:
PubMed Identifier
24652353
Citation
Pinzon DC, Zamora K, Martinez JH, Florez-Lopez ME, de Plata AC, Mosquera M, Ramirez-Velez R. Type of delivery and gestational age is not affected by pregnant Latin-American women engaging in vigorous exercise: a secondary analysis of data from a controlled randomized trial. Rev Salud Publica (Bogota). 2012 Oct;14(5):731-43.
Results Reference
derived
PubMed Identifier
21091415
Citation
Montoya Arizabaleta AV, Orozco Buitrago L, Aguilar de Plata AC, Mosquera Escudero M, Ramirez-Velez R. Aerobic exercise during pregnancy improves health-related quality of life: a randomised trial. J Physiother. 2010;56(4):253-8. doi: 10.1016/s1836-9553(10)70008-4.
Results Reference
derived
PubMed Identifier
19919718
Citation
Ramirez-Velez R, Aguilar AC, Mosquera M, Garcia RG, Reyes LM, Lopez-Jaramillo P. Clinical trial to assess the effect of physical exercise on endothelial function and insulin resistance in pregnant women. Trials. 2009 Nov 17;10:104. doi: 10.1186/1745-6215-10-104.
Results Reference
derived

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Influence of Physical Exercise on Endothelial Function in Pregnant Women

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