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Exercise and Pregnancy: Randomized Clinical Trial

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by Universidade Estadual da Paraiba.
Recruitment status was:  Recruiting
University of Campinas, Brazil
Information provided by (Responsible Party):
Adriana Suely de Oliveira Melo, Universidade Estadual da Paraiba Identifier:
First received: March 17, 2008
Last updated: December 12, 2011
Last verified: December 2011
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.

Condition Intervention
Gestational Diabetes
Other: Physical exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of Physical Exercise During Pregnancy on the Maternal and Perinatal Outcomes: A Randomized Clinical Trial

Resource links provided by NLM:

Further study details as provided by Universidade Estadual da Paraiba:

Primary Outcome Measures:
  • 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 ]

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

Estimated Enrollment: 188
Study Start Date: April 2008
Estimated Study Completion Date: December 2011
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: physical activity; physical exercise; walking
No Intervention: 1
Pregnant women without exercise practice.

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.

Ages Eligible for Study:   10 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00641550

Universidade Estadual da Paraiba
Campina Grande, Paraiba, Brazil, 58100-000
Universidade Estadual da Paraíba
Campina Grande, Paraíba, Brazil, 58100-000
Sponsors and Collaborators
Universidade Estadual da Paraiba
University of Campinas, Brazil
Study Director: Melania Amorim, PhD Instituto Materno Infantil Prof. Fernando Figueira
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Adriana Suely de Oliveira Melo, MD, MSc, Universidade Estadual da Paraiba Identifier: NCT00641550     History of Changes
Other Study ID Numbers: EXERC01 
Study First Received: March 17, 2008
Last Updated: December 12, 2011

Keywords provided by Universidade Estadual da Paraiba:
physical exercise
maternal complications
preterm labor
Apgar scores

Additional relevant MeSH terms:
Diabetes, Gestational
Hypertension, Pregnancy-Induced
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on February 20, 2017