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

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

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Pregnancy
• Intervention / Treatment: Other: Physical exercise program

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: João Guilherme Bezerra Alves, PhD; Phone Number: +55 81 21224122; Email: joaoguilherme@imip.org.br
• Study Contact Backup: Name: Karine Ferreira Agra, Master; Phone Number: +55 81 21224122; Email: karine_agra@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; The control group will follow the IMIP prenatal routine.
Experimental: 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.	Other: Physical exercise program; 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.; Other Names: Walking

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Karine Ferreira Agra
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico; Professor Fernando Figueira Integral Medicine Institute
• Investigators: Study Director: José Roberto da Silva Junior, Master, Professor Fernando Figueira Integral Medicine Institute; Study Chair: Isabelle Eunice de Albuquerque Pontes, Master, Professor Fernando Figueira Integral Medicine Institute; Principal Investigator: João Guilherme Bezerra Alves, PhD, Professor Fernando Figueira Integral Medicine Institute; Study Chair: Karine Ferreira Agra, Master, Professor Fernando Figueira Integral Medicine Institute

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: February 25, 2015
• First Submitted That Met QC Criteria: March 18, 2015
• First Posted (Estimate): March 19, 2015

Study Record Updates

• Last Update Posted (Estimate): March 19, 2015
• Last Update Submitted That Met QC Criteria: March 18, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Physical Activity; Obesity; Pregnancy; Microcirculation; Pregnancy Outcome
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: U1111-1161-5873