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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02392741
• Other study ID #: U1111-1161-5873
• Status: Not yet recruiting
• Phase: N/A
• First received: February 25, 2015
• Last updated: March 18, 2015
• Start date: March 2015
• Est. completion date: March 2017

Study information

• Verified date: March 2015
• Source: Professor Fernando Figueira Integral Medicine Institute
• Contact: João Guilherme Bezerra Alves, PhD
• Phone: +55 81 21224122
• Email: joaoguilherme[@]imip.org.br
• Is FDA regulated: No
• Health authority: Brazil: National Research Ethics Commission (CONEP)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Karine Ferreira Agra	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Professor Fernando Figueira Integral Medicine Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Gestational age at delivery	gestational age at delivery measured in complete weeks - numeric variable and discrete	at delivery	No
Secondary	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	No
Secondary	birth weight	quantitative and continuous variable measures in grams.	at birth	No
Secondary	birth height	quantitative and continuous variable measured in centimeters.	at birth	No
Secondary	Apgar score	scale ranging from one to ten according to health conditions at birth. Nominal variable, dichotomous type (one to ten).	at birth	No
Secondary	head circumference	head circumference of newborns measured in centimeters, according to the registration statement of anthropometric characteristics at birth.	at birth	No
Secondary	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	No
Secondary	Occurrence of birth trauma	information obtained through medical records. Nominal variable, dichotomous yes / no.	at birth	No
Secondary	necessity of hospitalization in the first week of life	information obtained through medical records. Nominal variable, dichotomous yes / no.	one week after delivery	No
Secondary	fetal or neonatal death	information obtained by death certificate. Nominal variable, dichotomous yes / no.	after delivery	No