Effect of Regular Exercise on Maternal Cardiovascular System During Pregnancy
Effect of Supervised Exercise Program on Cardiovascular Function and Structure in Pregnant Women. Randomized Controlled Trial
1 other identifier
interventional
800
1 country
1
Brief Summary
The main aim of this study was to analysed the security of a supervised exercise program on maternal cardiovascular system and assess the positive effects of this program on maternal cardiovascular function and structure
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pregnancy
Started Feb 2009
Longer than P75 for not_applicable pregnancy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 5, 2012
CompletedFirst Posted
Study publicly available on registry
November 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedNovember 14, 2014
March 1, 2014
5.3 years
November 5, 2012
November 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from cardiovascular function at the end of pregnancy: Stroke volume
Data were collected in second and third trimester
Weeks 20 and 34
Change from cardiovascular structure at the end of the pregnancy
Data were collected in second and third trimester
Weeks 20 and 34
Secondary Outcomes (1)
Maternal and fetal pregnancy outcomes
During pregnancy. At the moment of delivery.
Study Arms (2)
Control
NO INTERVENTIONSedentary pregnant women
Exercise group
EXPERIMENTALInterventions
Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60 of maximal heart rate. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate.
Eligibility Criteria
You may qualify if:
- Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
- Being able to communicate in spanish
- Giving birth at Hospital Universitario de Fuenlabrada and Hospital Universitario Severo Ochoa (Madrid).
You may not qualify if:
- Multiparity
- Obstetrician complications
- Being interested in the study after 18 weeks
- Not being regular in physical exercise program
- Younger than 18 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidad Politecnica de Madrid
Madrid, Madrid, 28040, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ruben Barakat, PhD
Universidad Politecnica de Madrid
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Student
Study Record Dates
First Submitted
November 5, 2012
First Posted
November 7, 2012
Study Start
February 1, 2009
Primary Completion
June 1, 2014
Study Completion
September 1, 2015
Last Updated
November 14, 2014
Record last verified: 2014-03