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

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.

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

Study design.

Figure 3

Study Timeline. CRF: Case report format.