Fetal Cardiovascular Response to Maternal Exercise During Third Trimester
Effect of a Specific Exercise Program During Whole Pregnancy on Fetal Heart Rate Response to Maternal Effort in Third Trimester. A Randomised Controlled Trial
1 other identifier
interventional
160
1 country
1
Brief Summary
The purpose of this study was to examine the behavior of the fetal heart rate in response to different intensities of acute maternal exercise in training and non-training pregnant women
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pregnancy
Started Mar 2010
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
March 1, 2010
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
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedNovember 14, 2014
August 1, 2012
3.2 years
November 5, 2012
November 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fetal heart rate
Fetal heart rate was measured before and after maternal walking exercise at 40 and 60% MaxHR
Up to 34 weeks
Secondary Outcomes (2)
Fetal outcomes
After labor
Maternal outcomes
During labor
Study Arms (2)
Control
NO INTERVENTIONSedentary pregnant women
Exercise group
EXPERIMENTALInterventions
The physical conditioning program included a total of three 55-60 minute sessions per week. Pregnant women started in 9-12 weeks and finished in 38-40 weeks, therefore, an average of 85 training sessions were planned for each participant. All subjects wore a heart rate (HR) monitor (Polar FT7, Finland) during the training sessions to ensure that the exercise intensity was light to moderate. Each session included a 25-minutes of aerobic exercise, 10-minutes of strength exercise and balance exercise as well, and 10-minutes of pelvic floor muscles training.
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
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
Study Officials
- STUDY DIRECTOR
Rubén Barakat, PhD
Universidad Politecnica de Madrid
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- 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
March 1, 2010
Primary Completion
May 1, 2013
Study Completion
June 1, 2015
Last Updated
November 14, 2014
Record last verified: 2012-08