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

K

Karine Ferreira Agra

Status

Unknown

Conditions

Obesity
Pregnancy

Treatments

Other: Physical exercise program

Study type

Interventional

Funder types

Other

Identifiers

NCT02392741
U1111-1161-5873

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Control
No Intervention group
Description:
The control group will follow the IMIP prenatal routine.
Physical exercise program
Experimental group
Description:
The intervention group witch will be submitted to an exercise program consisting of daily post prandial, 10' after breakfast, lunch and dinner.
Treatment:
Other: Physical exercise program

Trial contacts and locations

0

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Central trial contact

Karine Ferreira Agra, Master; João Guilherme Bezerra Alves, PhD

Data sourced from clinicaltrials.gov

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