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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
Karine Ferreira Agra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Physical Activity, Microcirculation, Pregnancy Outcome, Obesity, Pregnancy

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

    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
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    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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