Clinical trial to assess the effect of physical exercise on endothelial function and insulin resistance in pregnant women

Robinson Ramírez-Vélez, Ana C Aguilar, Mildrey Mosquera, Ronald G Garcia, Laura M Reyes, Patricio López-Jaramillo, Robinson Ramírez-Vélez, Ana C Aguilar, Mildrey Mosquera, Ronald G Garcia, Laura M Reyes, Patricio López-Jaramillo

Abstract

Background: Preeclampsia (PE) is a common maternal disease that complicates 5 to 10% of pregnancies and remains as the major cause of maternal and neonatal mortality. Cost-effective interventions aimed at preventing the development of preeclampsia are urgently needed. However, the pathogenesis of PE is not well known. Multiple mechanisms such as oxidative stress, endothelial dysfunction and insulin resistance may contribute to its development. Regular aerobic exercise recovers endothelial function; improves insulin resistance and decreases oxidative stress. Therefore the purpose of this clinical trial is to determine the effect of regular aerobic exercise on endothelial function, on insulin resistance and on pregnancy outcome.

Methods and design: 64 pregnant women will be included in a blind, randomized clinical trial, and parallel assignment. The exercise group will do regular aerobic physical exercise: walking (10 minutes), aerobic exercise (30 minutes), stretching (10 minutes) and relaxation exercise (10 minutes) in three sessions per week. Control group will do the activities of daily living (bathing, dressing, eating, and walking) without counselling from a physical therapist.

Trial registration: NCT00741312.

Figures

Figure 1
Figure 1
Expected benefits of exercise during pregnancy. Solid-line boxes represent the effects of preeclampsia and endothelial dysfunction. Dashed-line boxes represent the effects of exercise.
Figure 2
Figure 2
Study design.
Figure 3
Figure 3
Study Timeline. CRF: Case report format.

References

    1. Maternal mortality in 2000: estimates developed by WHO, UNICEF and UNFPA. World Health Organization; 2004.
    1. World Health Organization. International Collaborative study of Hypertensive Disorders of Pregnancy. Geographic variation in the incidence of hypertension in pregnancy. Am J Obstet Gynecol. 1988;158:80–83.
    1. López-Jaramillo P, Garcia R, López M. Preventing pregnancy induced hypertension: are there regional differences for this global problem? J Hypertens. 2005;6:1121–1129.
    1. Gomez P, Ruiz N, Pulido J. Mortalidad maternal en el Instituto Materno Infantil de Santafé de Bogotá D.C. 1985-1989. Rev Col Obstet Gynecol. 1993;44:39–47.
    1. Herrera JA, Chaudhuri G, López-Jaramillo. Is infection a major risk factor for preeclampsia? Medical Hypotheses. 2001;57:393–397. doi: 10.1054/mehy.2001.1378.
    1. López-Jaramillo P. Calcium, Nitric Oxide, and Preeclampsia. Sem Perinatol. 2000;24:33–36. doi: 10.1016/S0146-0005(00)80052-X.
    1. López-Jaramillo P, Casas JP, Serrano NC. Preeclampsia: from epidemiological observations to molecular mechanisms. Braz J Med Biol Res. 2001;34:1227–1235. doi: 10.1590/S0100-879X2001001000001.
    1. Lopez-Jaramillo P, Garcia RG, Reyes L, Ruiz S. Appropriate prenatal care: the best way to prevent preeclampsia in Andean Countries. Colombia Medica. 2009;40:226–230.
    1. Lopez-Jaramillo P, Arenas WD, Garcia RG, Rincon MY, Lopez M. The role of the L-arginine-nitric oxide pathway in preeclampsia. Ther Adv Cardiovasc Dis. 2008;2:261–275. doi: 10.1177/1753944708092277.
    1. Friedman SA. Preeclampsia: a review of the role of prostaglandins. Obstet Gynecol. 1988;71:122–137.
    1. Félix C, Lòpez A, Delgado F, Amores E, Narváez M, López-Jaramillo P. Vascular production of prostacyclin in Andean women with pregnancy-induced hypertension. Braz J Med Biol Res. 1991;24:59–62.
    1. Yeo SA, Steele NM, Chang M-C, Leclaire SM, Roind DL, Hayashi R. Effect of exercise on blood pressure in pregnant women with a high risk of gestational hypertensive disorders. J Reprod Med. 2000;45:293–298.
    1. American College of Obstetricians and Gynecologists, Committee on Obstetric Exercise. Committee opinion No. 267: exercise during pregnancy and the postpartum period. Obstet Gynecol. 2002;99:171–173. doi: 10.1016/S0029-7844(01)01749-5.
    1. Lavrencic A, Salobir BG, Keber I. Physical training improves flow-mediated dilation in patients with the polymetabolic syndrome. Arterioscler Thromb Vasc Biol. 2000;20:551–555.
    1. Clapp JF, Little KD. The interaction between regular exercise and selected aspects of women's health. Am J Obstet Gynecol. 1995;173:2–9. doi: 10.1016/0002-9378(95)90160-4.
    1. Alderman B, Zhao H, Holt V, Watts H, Beresford S. Maternal Physical Activity in Pregnancy and Infant Size for Gestational Age. Ann Epidemiol. 1998;8:513–519. doi: 10.1016/S1047-2797(98)00020-9.
    1. Clapp JF, Dickstein S. Endurance exercise and pregnancy outcome. Med Sci Sports Exerc. 1984;16:556–562.
    1. Hatch MC, Shu X-O, McLean DE, Levin B, Begg M, Reuss L. Maternal exercise during pregnancy, physical fitness, and fetal growth. Am J Epidemiol. 1993;137:1105–1114.
    1. Hassan TJ, Ibrahim K, Sadiqua NJ. Excessive physical work during pregnancy and birth weight. Asia-Oceania J Obstet Gynaecol. 1990;16:17–20.
    1. Dempsey JC, Sorensen TK, Williams MA, Lee I-M, Miller RS, Dashow EE. Prospective study of gestational diabetes mellitus in relation to maternal recreational physical activity before and during pregnancy. Am J Epidemiol. 2004;159:663–670. doi: 10.1093/aje/kwh091.
    1. Marcoux S, Brisson J, Fabia J. The effect of leisure time physical activity on the risk of pre eclampsia and gestational hypertension. J Epidemiol Community Health. 1989;43:147–152. doi: 10.1136/jech.43.2.147.
    1. Sorensen TK, Williams MA, Lee I-M, Dashow EE, Thompson ML, Luthy DA. Recreational physical activity during pregnancy and risk of preeclampsia. Hypertension. 2003;41:1273–1280. doi: 10.1161/01.HYP.0000072270.82815.91.
    1. Celermajer DS, Sorensen KE, Gooch VM, Spiegelhalter DJ, Miller OI, Sullivan ID. Non-invasive detection of endothelial dysfunction in children and adults at risk of atherosclerosis. Lancet. 1992;340:1111–1115. doi: 10.1016/0140-6736(92)93147-F.
    1. Accini L, Sotomayor A, Trujillo F, Barrera JG, Bautista L, López-Jaramillo P. Colombian Study to Assess the Use of Noninvasive Determination of Endothelium-Mediated Vasodilatation (CANDEV). Normal Values and Factors Associated. Endothelium. 2001;8:157–166.
    1. Dørup I, Skajaa K, Sørensen KE. Normal pregnancy is associated with enhanced endothelium-dependent flow-mediated vasodilation. Am J Physiol Heart Circ Physiol. 1999;276:821–825.
    1. Sierra-Laguado J, Garcia RG, Lopez-Jaramillo P. Flow -mediated dilation of the brachial artery in pregnancy. Int J Gynaecol Obstet. 2006;93:60–1. doi: 10.1016/j.ijgo.2006.01.015.
    1. ACOG Committee on Obstetric Practice. ACOG Committee Opinion, Number 267, January 2002. Exercise during pregnancy and the postpartum period. Obstetrics and Gynecology. 2002;99:171–173. doi: 10.1016/S0029-7844(01)01749-5.
    1. ACSM's Guidelines for Exercise Testing and Prescription. 6. Philadelphia, PA Lippincott Williams & Wilkins; 2000.
    1. Lemeshow S, Hosmer D, Klar J, Lwanga SK. Adequacy of Sample Size in Health Studies. John Wiley & Sons, Inc. 1990.
    1. Villalobos-Alcázar G, Guzmán-Bárcenas J, Alonso-de la Vega P, Ortiz-Rodríguez V, Casanueva E. Evaluación antropométrica del recién nacido. Variabilidad de los observadores. Perinatol Reprod Hum. 2002;16:74–79.
    1. Lohman T, Roche A, Martorel R, editor. The Airle (VA) consensus Conference. Champaign, 11 Human Kinetics; 1988. Standarizaton of anthropometric measurements; pp. 39–80.
    1. Pickering TG. Recommendations for the use of home (self) and ambulatory blood pressure monitoring. American Society of Hypertension Ad Hoc Panel. Am J Hypertens. 1996;9:1–11. doi: 10.1016/0895-7061(95)00341-X.
    1. Kyle UG, Schutz Y, Dupertuis YM, Pichard C. Body composition interpretation. Contributions of the fat-free mass index and the body fat mass index. Nutrition. 2003;19(7-8):597–604. doi: 10.1016/S0899-9007(03)00061-3.
    1. Corretti MC, Anderson TJ, Benjamin EJ, Celermajer D, Charbonneau F, Creager MA. International brachial artery reactivity task force. Guidelines for the ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery: a report of the international brachial artery reactivity task force. J Am Coll Cardiol. 2002;39:257–265. doi: 10.1016/S0735-1097(01)01746-6.
    1. Joannides R, Haefeli WE, Linder L, Richard V, Bakkali H, Thuillez C, Luscher TF. Nitric oxide is responsible for flow-dependent dilatation of human peripheral conduit arteries in vivo. Circulation. 1995;91:1314–1319.
    1. Sorensen KE, Celermajer DS, Spiegelhalter DJ, Georgakopoulos D, Robinson J, Thomas O, Deanfield JE. Non-invasive measurement of human endothelium dependent arterial responses: accuracy and reproducibility. Br Heart J. 1995;74:247–253. doi: 10.1136/hrt.74.3.247.
    1. Silva S, Villamizar C, Villamizar N, Silva F, Luengas C, Casas JP. Colombian study to assess the use of noninvasive determination of Endothelium-mediated vasodilation (CANDEV). II. Does location of the occlusion device affects Diagnostic accuracy? Endothelium. 2005;12:107–111. doi: 10.1080/10623320500189798.
    1. Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem. 1972;18:499–502.
    1. Eda S, Kaufmann J, Roos W, Pohl S. Development of a new microparticle-enhanced turbidimetric assay for C-reactive protein with superior features in analytical sensitivity and dynamic range. J Clin Lab Anal. 1998;12:137–144. doi: 10.1002/(SICI)1098-2825(1998)12:3<137::AID-JCLA2>;2-6.
    1. Green LC, Wagner DA, Glogowski J, Skipper PL, Wishnok JS. Analysis of nitrate, nitrite and (15N) nitrate in biological fluids. Anal Biochem. 1982;126:131–138. doi: 10.1016/0003-2697(82)90118-X.
    1. Honma M, Satoh T, Takezawa J, Ui M. An ultrasensitive method for the simultaneous determination of cyclic AMP and cyclic GMP in small-volume samples from blood and tissue. Biochem Med. 1977;18:257–273. doi: 10.1016/0006-2944(77)90060-6.
    1. Barakat R, Stirling JR, Lucia A. Does exercise training during pregnancy affect gestational age? A randomised controlled trial. Br J Sports Med. 2008;42:674–648. doi: 10.1136/bjsm.2008.047837.
    1. Boutron I, Moher D, Altman DG, Schulz K, Ravaud P, for the CONSORT group. Extending the CONSORT Statement to randomized trials of nonpharmacologic treatment explanation and elaboration. Ann Intern Med. 2008. pp. 295–309.

Source: PubMed

3
구독하다