- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00641550
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:
- To describe and compare biological and obstetrical variables.
- To study doppler flow velocimetry indexes.
- To determine the association between physical exercise and maternal complications: preeclampsia, preterm labor, gestational diabetes and weight gain in pregnancy.
- 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 Contact
- Name: Adriana Melo, MSc
- Phone Number: 55-83-99732726
- Email: asomelo@gmail.com
Study Contact Backup
- Name: Melania Amorim, PhD
- Phone Number: 55-83-88221514
- Email: melamorim@uol.com.br
Study Locations
-
-
Paraiba
-
Campina Grande, Paraiba, Brazil, 58100-000
- Recruiting
- Universidade Estadual da Paraiba
-
Contact:
- Adriana Melo, MSc
- Phone Number: 55-83-99732726
- Email: asomelo@gmail.com
-
Contact:
- Melania Amorim, PhD
- Phone Number: 55-83-88221514
- Email: melamorim@uol.com.br
-
Principal Investigator:
- Adriana Melo, MSc
-
-
Paraíba
-
Campina Grande, Paraíba, Brazil, 58100-000
- Recruiting
- Universidade Estadual da Paraiba
-
Contact:
- Adriana Melo, MSc
- Phone Number: 55-83-99732726
- Email: asomelo@gmail.com
-
Contact:
- Melania Amorim, PhD
- Phone Number: 55-83-88221514
- Email: melamorim@uol.com.br
-
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)
|
Walking 3 times a week during 1 hours (moderate activity)
Other Names:
|
Experimental: 3
Pregnant women starting exercise at 20 weeks
|
Walking 3 times a week during 1 hours (moderate activity)
Other Names:
|
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
Collaborators
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.
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
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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