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ObesityNCT02392741

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

A study testing Physical exercise program in people with Obesity and Pregnancy, run by Karine Ferreira Agra.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Obesity, Pregnancy
What is being tested?
Physical exercise program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
Mar 2015to Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Singleton pregnancy between 14 and 20 weeks gestation;
  • Literate women;
  • sedentary lifestyle.

Who cannot join

  • 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 locations and contacts

No sites are listed yet.

João Guilherme Bezerra Alves, PhD contact

+55 81 21224122

joaoguilherme@imip.org.br

Karine Ferreira Agra, Master contact

+55 81 21224122

karine_agra@hotmail.com

About this study

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

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.

Read the 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.

Conditions
Obesity, Pregnancy
Being tested
Physical exercise program
Keywords
Physical Activity, Microcirculation, Pregnancy Outcome, Obesity, Pregnancy
Medical subject headings
Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical exercise programOther

    Also called Walking

    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.

Study groups in NCT02392741
Study groupRoleWhat they receive
ControlNo interventionThe control group will follow the IMIP prenatal routine.
Physical exercise programExperimentalThe intervention group witch will be submitted to an exercise program consisting of daily post prandial, 10' after breakfast, lunch and dinner.
Receives: Other: Physical exercise program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: change from baseline microcirculation after 8 weeks

Secondary outcomes (14)

  1. 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.

    Measured: at 30 weeks gestation

  2. 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.

    Measured: at 30 weeks gestation

  3. 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.

    Measured: at 30 weeks gestation

  4. 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.

    Measured: at admission on the study and till 40 weeks gestation

  5. Gestational age at delivery

    gestational age at delivery measured in complete weeks - numeric variable and discrete

    Measured: at delivery

  6. 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.

    Measured: within 42 days of termination of pregnancy

  7. birth weight

    quantitative and continuous variable measures in grams.

    Measured: at birth

  8. birth height

    quantitative and continuous variable measured in centimeters.

    Measured: at birth

  9. Apgar score

    scale ranging from one to ten according to health conditions at birth. Nominal variable, dichotomous type (one to ten).

    Measured: at birth

  10. head circumference

    head circumference of newborns measured in centimeters, according to the registration statement of anthropometric characteristics at birth.

    Measured: at birth

  11. Waist circumference

    waist circumference of the newborn measured in centimeters, according to the registration statement of anthropometric characteristics at birth. Numerical variable, continuous.

    Measured: at birth

  12. Occurrence of birth trauma

    information obtained through medical records. Nominal variable, dichotomous yes / no.

    Measured: at birth

  13. necessity of hospitalization in the first week of life

    information obtained through medical records. Nominal variable, dichotomous yes / no.

    Measured: one week after delivery

  14. fetal or neonatal death

    information obtained by death certificate. Nominal variable, dichotomous yes / no.

    Measured: after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionDec 2015 (estimated)
  4. Study completionMar 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02392741
Sponsor's protocol ID
U1111-1161-5873
Status last verified
Mar 2015
First submitted
25 Feb 2015
Last updated
19 Mar 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Physical exercise program in people with Obesity and Pregnancy, run by Karine Ferreira Agra.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact João Guilherme Bezerra Alves, PhD (+55 81 21224122, joaoguilherme@imip.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effects on microcirculation (time frame: change from baseline microcirculation after 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02392741.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2015.

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