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

NCT ID: NCT02392741

Last Updated: 2015-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-03-31

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.

Conditions

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Obesity Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

The control group will follow the IMIP prenatal routine.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Physical exercise program

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Walking

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Professor Fernando Figueira Integral Medicine Institute

OTHER

Sponsor Role collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Karine Ferreira Agra

OTHER

Sponsor Role lead

Responsible Party

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Karine Ferreira Agra

Master in Health

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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José Roberto da Silva Junior, Master

Role: STUDY_DIRECTOR

Professor Fernando Figueira Integral Medicine Institute

Isabelle Eunice de Albuquerque Pontes, Master

Role: STUDY_CHAIR

Professor Fernando Figueira Integral Medicine Institute

João Guilherme Bezerra Alves, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor Fernando Figueira Integral Medicine Institute

Karine Ferreira Agra, Master

Role: STUDY_CHAIR

Professor Fernando Figueira Integral Medicine Institute

Central Contacts

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João Guilherme Bezerra Alves, PhD

Role: CONTACT

+55 81 21224122

Karine Ferreira Agra, Master

Role: CONTACT

+55 81 21224122

Other Identifiers

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U1111-1161-5873

Identifier Type: -

Identifier Source: org_study_id

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