Exercise and Pregnancy: Randomized Clinical Trial

December 12, 2011 updated by: Adriana Suely de Oliveira Melo, Universidade Estadual da Paraiba

Effects of Physical Exercise During Pregnancy on the Maternal and Perinatal Outcomes: A Randomized Clinical Trial

The effects of physical exercise on pregnancy remain to be elucidated. A randomized controlled trial will be conducted to study the impact of exercise on maternal and perinatal outcomes. Our hypothesis is that physical exercise reduces preeclampsia incidence and improves birthweight when started early in pregnancy, with no impact on pregnancy duration, Apgar scores and neonatal complications.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The study will include low risk pregnant women randomized to practice physical exercise beginning at 13 weeks, 20 weeks or no exercise group.

The objectives are:

  1. To describe and compare biological and obstetrical variables.
  2. To study doppler flow velocimetry indexes.
  3. To determine the association between physical exercise and maternal complications: preeclampsia, preterm labor, gestational diabetes and weight gain in pregnancy.
  4. To determine the association between physical exercise and perinatal outcomes: Apgar scores, birthweight, admission at intensive neonatal care unit, body composition and neonatal complications.

Study Type

Interventional

Enrollment (Anticipated)

188

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Paraiba
      • Campina Grande, Paraiba, Brazil, 58100-000
        • Recruiting
        • Universidade Estadual da Paraiba
        • Contact:
        • Contact:
        • Principal Investigator:
          • Adriana Melo, MSc
    • Paraíba
      • Campina Grande, Paraíba, Brazil, 58100-000
        • Recruiting
        • Universidade Estadual da Paraiba
        • Contact:
        • Contact:
        • Principal Investigator:
          • Adriana Melo, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Gestational age < 13 weeks
  • Single pregnancy
  • Alive fetus
  • No previous practice of physical activity

Exclusion Criteria:

  • Smoking
  • Chronic maternal diseases
  • Placenta praevia
  • History of preterm labor
  • Bleeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Pregnant women starting to practice physical exercise at 13 weeks(Walking moderate activity)
Other: Physical exercise
Walking 3 times a week during 1 hours (moderate activity)
Other Names:
  • physical activity; physical exercise; walking
Experimental: 3
Pregnant women starting exercise at 20 weeks
Other: Physical exercise
Walking 3 times a week during 1 hours (moderate activity)
Other Names:
  • physical activity; physical exercise; walking
No Intervention: 1
Pregnant women without exercise practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maternal outcome: preterm labor, weight gain, preeclampsia, gestational diabetes Perinatal outcome: birthweight, Apgar scores, body composition, admission at neonatal intensive care unit
Time Frame: nine months
nine months

Secondary Outcome Measures

Outcome Measure
Time Frame
Doppler flow velocimetry indexes: pulsatility, resistance and A/B relation (uterine arteries, fetal middle cerebral artery and umbilical arteries)
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Estadual da Paraiba

Collaborators

University of Campinas, Brazil

Investigators

  • Study Director: Melania Amorim, PhD, Instituto Materno Infantil Prof. Fernando Figueira

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

March 17, 2008

First Submitted That Met QC Criteria

March 17, 2008

First Posted (Estimate)

March 24, 2008

Study Record Updates

Last Update Posted (Estimate)

December 13, 2011

Last Update Submitted That Met QC Criteria

December 12, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXERC01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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