Effects of a Physical Exercise Program on Microcirculation and Pregnancy Outcomes in Obese Pregnant Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of a Physical Exercise Program on Microcirculation and Pregnancy Outcomes in Obese Pregnant Women: Randomized Clinical Trial

Conditions
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Obesity, Pregnancy

Intervention / Treatment
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* Other: Physical exercise program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton pregnancy between 14 and 20 weeks gestation; Literate women; sedentary lifestyle. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>The control group will follow the IMIP prenatal routine. | |
| Experimental: Physical exercise program<br>The intervention group witch will be submitted to an exercise program consisting of daily post prandial, 10' after breakfast, lunch and dinner. | Other: Physical exercise program<br>* The intervention consists to an exercise program composed by a daily post prandial, 10' after breakfast, lunch and dinner, totaling 150' weekly, for eight weeks.<br>* Other names: Walking;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on microcirculation | 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. | change from baseline microcirculation after 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational diabetes | 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. | at 30 weeks gestation | 
| Gestational hypertension | 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. | at 30 weeks gestation | 
| Preeclampsia | 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. | at 30 weeks gestation | 
| Weight gain | 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. | at admission on the study and till 40 weeks gestation | 
| Gestational age at delivery | gestational age at delivery measured in complete weeks - numeric variable and discrete | at delivery | 
| Maternal death | 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. | within 42 days of termination of pregnancy | 
| birth weight | quantitative and continuous variable measures in grams. | at birth | 
| birth height | quantitative and continuous variable measured in centimeters. | at birth | 
| Apgar score | scale ranging from one to ten according to health conditions at birth. Nominal variable, dichotomous type (one to ten). | at birth | 
| head circumference | head circumference of newborns measured in centimeters, according to the registration statement of anthropometric characteristics at birth. | at birth | 
| Waist circumference | waist circumference of the newborn measured in centimeters, according to the registration statement of anthropometric characteristics at birth. Numerical variable, continuous. | at birth | 
| Occurrence of birth trauma | information obtained through medical records. Nominal variable, dichotomous yes / no. | at birth | 
| necessity of hospitalization in the first week of life | information obtained through medical records. Nominal variable, dichotomous yes / no. | one week after delivery | 
| fetal or neonatal death | information obtained by death certificate. Nominal variable, dichotomous yes / no. | after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Activity, Microcirculation, Pregnancy Outcome, Obesity, Pregnancy