Influence of Physical Exercise on Endothelial Function in Pregnant Women
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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 |
- Brachial artery flow-mediated dilation [ Time Frame: Baseline, 8 weeks, 16 weeks ] [ Designated as safety issue: No ]
- 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 |
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| Colombia | |
| Centro de Salud Cañaveralejo | |
| Cali, Valle, Colombia | |
| 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 May 21, 2013