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| Name | Class |
|---|---|
| Fundación Cardiovascular de Colombia | OTHER |
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The purpose of this study is to determine the effect of regular aerobic exercise on endothelial function in pregnancy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Experimental |
| |
| II | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regular aerobic physical exercise | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Brachial artery flow-mediated dilation | Baseline, 8 weeks, 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| high sensitivity C-Reactive Protein | Baseline, 16 weeks | |
| Nitrates, Nitrites and cyclic GMP | Baseline, 16 weeks | |
| Blood lipid profile |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana C Plata, MSc | Universidad del Valle | Principal Investigator |
| Adalberto Sanchez, PhD | Universidad del Valle | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Salud Cañaveralejo | Cali | Valle del Cauca Department | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24652353 | Derived | 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. | |
| 21091415 |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000203 | Activities of Daily Living |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| Activities of daily living | Behavioral | Basic activities of daily living (bathing, dressing, eating, walking) without counseling by a physical therapist. |
|
| Baseline, 16 weeks |
| Anthropometric indicators | Baseline, 8 weeks, 16 weeks |
| Functional capacity (VO2 Max) | Baseline, 8 weeks, 16 weeks |
| Maternal and neonatal outcomes | At delivery |
| 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. |
| 19919718 | Derived | 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. |
| D001519 | Behavior |
| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |