Effects of a Physical Exercise Program on Microcirculation and Pregnancy Outcomes in Obese Pregnant Women
Primary Purpose
Obesity, Pregnancy
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical exercise program
Sponsored by

About this trial
This is an interventional treatment trial for Obesity focused on measuring Physical Activity, Microcirculation, Pregnancy Outcome, Obesity, Pregnancy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Physical exercise program
Arm Description
The control group will follow the IMIP prenatal routine.
The intervention group witch will be submitted to an exercise program consisting of daily post prandial, 10' after breakfast, lunch and dinner.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Gestational age at delivery
gestational age at delivery measured in complete weeks - numeric variable and discrete
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.
birth weight
quantitative and continuous variable measures in grams.
birth height
quantitative and continuous variable measured in centimeters.
Apgar score
scale ranging from one to ten according to health conditions at birth. Nominal variable, dichotomous type (one to ten).
head circumference
head circumference of newborns measured in centimeters, according to the registration statement of anthropometric characteristics 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.
Occurrence of birth trauma
information obtained through medical records. Nominal variable, dichotomous yes / no.
necessity of hospitalization in the first week of life
information obtained through medical records. Nominal variable, dichotomous yes / no.
fetal or neonatal death
information obtained by death certificate. Nominal variable, dichotomous yes / no.
Full Information
NCT ID
NCT02392741
First Posted
February 25, 2015
Last Updated
March 18, 2015
Sponsor
Karine Ferreira Agra
Collaborators
Professor Fernando Figueira Integral Medicine Institute, Conselho Nacional de Desenvolvimento Científico e Tecnológico
1. Study Identification
Unique Protocol Identification Number
NCT02392741
Brief Title
Effects of a Physical Exercise Program on Microcirculation and Pregnancy Outcomes in Obese Pregnant Women
Official Title
Effects of a Physical Exercise Program on Microcirculation and Pregnancy Outcomes in Obese Pregnant Women: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
March 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Karine Ferreira Agra
Collaborators
Professor Fernando Figueira Integral Medicine Institute, Conselho Nacional de Desenvolvimento Científico e Tecnológico
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Pregnancy
Keywords
Physical Activity, Microcirculation, Pregnancy Outcome, Obesity, Pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will follow the IMIP prenatal routine.
Arm Title
Physical exercise program
Arm Type
Experimental
Arm Description
The intervention group witch will be submitted to an exercise program consisting of daily post prandial, 10' after breakfast, lunch and dinner.
Intervention Type
Other
Intervention Name(s)
Physical exercise program
Other Intervention Name(s)
Walking
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effects on microcirculation
Description
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.
Time Frame
change from baseline microcirculation after 8 weeks
Secondary Outcome Measure Information:
Title
Gestational diabetes
Description
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.
Time Frame
at 30 weeks gestation
Title
Gestational hypertension
Description
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.
Time Frame
at 30 weeks gestation
Title
Preeclampsia
Description
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.
Time Frame
at 30 weeks gestation
Title
Weight gain
Description
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.
Time Frame
at admission on the study and till 40 weeks gestation
Title
Gestational age at delivery
Description
gestational age at delivery measured in complete weeks - numeric variable and discrete
Time Frame
at delivery
Title
Maternal death
Description
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.
Time Frame
within 42 days of termination of pregnancy
Title
birth weight
Description
quantitative and continuous variable measures in grams.
Time Frame
at birth
Title
birth height
Description
quantitative and continuous variable measured in centimeters.
Time Frame
at birth
Title
Apgar score
Description
scale ranging from one to ten according to health conditions at birth. Nominal variable, dichotomous type (one to ten).
Time Frame
at birth
Title
head circumference
Description
head circumference of newborns measured in centimeters, according to the registration statement of anthropometric characteristics at birth.
Time Frame
at birth
Title
Waist circumference
Description
waist circumference of the newborn measured in centimeters, according to the registration statement of anthropometric characteristics at birth. Numerical variable, continuous.
Time Frame
at birth
Title
Occurrence of birth trauma
Description
information obtained through medical records. Nominal variable, dichotomous yes / no.
Time Frame
at birth
Title
necessity of hospitalization in the first week of life
Description
information obtained through medical records. Nominal variable, dichotomous yes / no.
Time Frame
one week after delivery
Title
fetal or neonatal death
Description
information obtained by death certificate. Nominal variable, dichotomous yes / no.
Time Frame
after delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
João Guilherme Bezerra Alves, PhD
Phone
+55 81 21224122
Email
joaoguilherme@imip.org.br
First Name & Middle Initial & Last Name or Official Title & Degree
Karine Ferreira Agra, Master
Phone
+55 81 21224122
Email
karine_agra@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Roberto da Silva Junior, Master
Organizational Affiliation
Professor Fernando Figueira Integral Medicine Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Isabelle Eunice de Albuquerque Pontes, Master
Organizational Affiliation
Professor Fernando Figueira Integral Medicine Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
João Guilherme Bezerra Alves, PhD
Organizational Affiliation
Professor Fernando Figueira Integral Medicine Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karine Ferreira Agra, Master
Organizational Affiliation
Professor Fernando Figueira Integral Medicine Institute
Official's Role
Study Chair
12. IPD Sharing Statement
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Effects of a Physical Exercise Program on Microcirculation and Pregnancy Outcomes in Obese Pregnant Women
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