Influence of Physical Exercise on Endothelial Function in Pregnant Women
Influence of Physical Exercise on Endothelial Function in Pregnant Women: Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
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Valle
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Cali, Valle, Colombia
- Centro de Salud Cañaveralejo
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: I
|
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. |
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Active Comparator: II
|
Basic activities of daily living (bathing, dressing, eating, walking) without counseling by a physical therapist.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Brachial artery flow-mediated dilation
Time Frame: Baseline, 8 weeks, 16 weeks
|
Baseline, 8 weeks, 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
high sensitivity C-Reactive Protein
Time Frame: Baseline, 16 weeks
|
Baseline, 16 weeks
|
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Nitrates, Nitrites and cyclic GMP
Time Frame: Baseline, 16 weeks
|
Baseline, 16 weeks
|
|
Blood lipid profile
Time Frame: Baseline, 16 weeks
|
Baseline, 16 weeks
|
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Anthropometric indicators
Time Frame: Baseline, 8 weeks, 16 weeks
|
Baseline, 8 weeks, 16 weeks
|
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Functional capacity (VO2 Max)
Time Frame: Baseline, 8 weeks, 16 weeks
|
Baseline, 8 weeks, 16 weeks
|
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Maternal and neonatal outcomes
Time Frame: At delivery
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At delivery
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ana C Plata, MSc, Universidad del Valle
- Principal Investigator: Adalberto Sanchez, PhD, Universidad del Valle
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 182-07
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