Clinical trial NCT02392741: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Pregnancy
Keywords: Physical Activity
Microcirculation
Pregnancy Outcome
Obesity
Pregnancy
Lead sponsor: Professor Fernando Figueira Integral Medicine Institute
Sponsor class: OTHER
Collaborators: name: Professor Fernando Figueira Integral Medicine Institute
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2015-03-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Effects on microcirculation
timeFrame: change from baseline microcirculation after 8 weeks
Secondary outcomes:
measure: Gestational diabetes
timeFrame: at 30 weeks gestation
measure: Gestational hypertension
timeFrame: at 30 weeks gestation
measure: Preeclampsia
timeFrame: at 30 weeks gestation
measure: Weight gain
timeFrame: at admission on the study and till 40 weeks gestation
measure: Gestational age at delivery
timeFrame: at delivery
measure: Maternal death
timeFrame: within 42 days of termination of pregnancy
measure: birth weight
timeFrame: at birth
measure: birth height
timeFrame: at birth
measure: Apgar score
timeFrame: at birth
measure: head circumference
timeFrame: at birth
measure: Waist circumference
timeFrame: at birth
measure: Occurrence of birth trauma
timeFrame: at birth
measure: necessity of hospitalization in the first week of life
timeFrame: one week after delivery
measure: fetal or neonatal death
timeFrame: after delivery
Other outcomes:
Locations:
Study officials:
affiliation: Professor Fernando Figueira Integral Medicine Institute
name: José Roberto da Silva Junior, Master
role: STUDY_DIRECTOR
affiliation: Professor Fernando Figueira Integral Medicine Institute
name: Isabelle Eunice de Albuquerque Pontes, Master
role: STUDY_CHAIR
affiliation: Professor Fernando Figueira Integral Medicine Institute
name: João Guilherme Bezerra Alves, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor Fernando Figueira Integral Medicine Institute
name: Karine Ferreira Agra, Master
role: STUDY_CHAIR
References: