Effects of a Physical Exercise Program on Microcirculation and Pregnancy Outcomes in Obese Pregnant Women
- Conditions
- PregnancyObesity
- Interventions
- Other: Physical exercise program
- Registration Number
- NCT02392741
- Lead Sponsor
- Karine Ferreira Agra
- Brief Summary
This study aims to determine the effect of a physical exercise program on microcirculation and maternal and perinatal outcomes in obese women. A randomized clinical trial will be performed at IMIP with obese pregnant women assisted at the Instituto de Medicina Integral Professor Fernando Figueira (IMIP) prenatal service.
- Detailed Description
Obesity in pregnancy is an important risk factor for adverse perinatal outcomes. Obesity leads to oxidative stress and vascular damage including microcirculation inflammation. Physical activity prevents cellular damage and provide a protective effect to the health of the mother and fetus. Although physical activity has been recommended for obese pregnant women, studies assessing the effects on the microcirculation of these women are scarce. This study aims to determine the effect of a physical exercise program on microcirculation and maternal and perinatal outcomes in obese women. A randomized clinical trial will be performed at IMIP with obese pregnant women assisted at the IMIP prenatal service. The intervention group will be submitted to an exercise program consisting of daily post prandial, 10' after breakfast, lunch and dinner. The control group will follow the routine prenatal IMIP. All pregnant women will be evaluated by a questionnaire to assess physical activity. Microcirculation function will be evaluated by a Laser-doppler flowmetry at baseline and eight weeks after intervention. All pregnant women will be followed until the delivery and immediate postpartum period to check their perinatal outcomes. All pregnant women will be advised to use a pedometer to record their daily steps. The study meets the recommendations of the National Health Council. This project was submitted and approved from the Ethics Committee for Research involving human subjets of IMIP. All participants will be duly informed about the aims of the study and will be included after signing the Informed Consent Form.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 60
- Singleton pregnancy between 14 and 20 weeks gestation;
- Literate women;
- sedentary lifestyle.
- Cognitive, auditory, visual or motor impairment, certified by a specialist;
- Any pregnancy disorders or previous maternal diseases: diabetes type 1 or type 2, hypertensive disorders of pregnancy, hemodynamic instability, renal disease or collagen, vaginal bleeding;
- Any medical or obstetric contraindication to perform physical activity.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Physical exercise program Physical exercise program The intervention group witch will be submitted to an exercise program consisting of daily post prandial, 10' after breakfast, lunch and dinner.
- Primary Outcome Measures
Name Time Method Effects on microcirculation change from baseline microcirculation after 8 weeks Microcirculation will be assessed using the Laser-doppler flowmetry manufacturers software (Moor Instruments, UK) and expressed in perfusion units (PU). The parameters that will be used to evaluate the microcirculation (microvascular function) are: resting skin blood flux (RF), maximum skin blood flux (MF) at peak PORH, the ratio of maximum level and flow at rest (MF/RF) and the area of hyperemia (AH) which is the graphical area under the curve formed during PORH.
- Secondary Outcome Measures
Name Time Method fetal or neonatal death after delivery information obtained by death certificate. Nominal variable, dichotomous yes / no.
Gestational hypertension at 30 weeks gestation hypertension diagnosed after the twentieth week of gestation in previously normotensive women, which is not accompanied by proteinuria. Nominal and dichotomous variable of yes/no.
Gestational age at delivery at delivery gestational age at delivery measured in complete weeks - numeric variable and discrete
birth weight at birth quantitative and continuous variable measures in grams.
head circumference at birth head circumference of newborns measured in centimeters, according to the registration statement of anthropometric characteristics at birth.
necessity of hospitalization in the first week of life one week after delivery information obtained through medical records. Nominal variable, dichotomous yes / no.
Gestational diabetes at 30 weeks gestation glucose\> 92mg / dl before ingestion of 75g of glucose; glucose\> 180 mg / dl one hour after the ingestion of 75g of glucose; glucose\> 153 mg / dL during the second hour after ingestion of 75 g glucose.
Weight gain at admission on the study and till 40 weeks gestation refers to the weight gain (kg) during pregnancy. Obtained from the difference between the weight in late pregnancy and the previous weight before pregnancy - numeric variable, continuous.
Apgar score at birth scale ranging from one to ten according to health conditions at birth. Nominal variable, dichotomous type (one to ten).
Waist circumference at birth waist circumference of the newborn measured in centimeters, according to the registration statement of anthropometric characteristics at birth. Numerical variable, continuous.
Occurrence of birth trauma at birth information obtained through medical records. Nominal variable, dichotomous yes / no.
Preeclampsia at 30 weeks gestation Hypertension accompanied by proteinuria\> 300 mg in a sample of 24 hours (or 1+ in qualitative dipstick test). Nominal and dichotomous variable of yes / no.
Maternal death within 42 days of termination of pregnancy death of women during or within 42 days of termination of pregnancy, irrespective of the duration or location of the pregnancy, caused by any factor related to or aggravated by pregnancy or by measures taken in relation to it. Nominal variable, dichotomous yes / no.
birth height at birth quantitative and continuous variable measured in centimeters.