Exercise During Pregnancy and Perinatal Outcome
1 other identifier
interventional
125
1 country
1
Brief Summary
Effect of Physical Exercise Program on fetoplacental circulation and perinatal outcome.
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 Nov 2014
Typical duration 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
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 21, 2016
CompletedFirst Posted
Study publicly available on registry
April 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedOctober 27, 2017
October 1, 2017
2.1 years
April 21, 2016
October 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maternal weight gain during pregnancy
From the beginning of the pregnancy to 1 month postdelivery
Secondary Outcomes (10)
Cesarean Section Rate
Birth
Gestational Diabetes
Birth
Preeclampsia
birth
Fetal TAPSE
up to 36 weeks of pregnancy
Fetal Tei Index
up to 36 weeks of pregnancy
- +5 more secondary outcomes
Study Arms (2)
Control Group
NO INTERVENTIONNon- supervised physical exercise program during pregnancy
Exercise Group
EXPERIMENTALSupervised physical exercise program during pregnancy
Interventions
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 heart rate reserve. 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:
- Healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
- Able to communicate in spanish
- Giving birth at Torrejon Universitary Hospital
You may not qualify if:
- Medical or obstetric complication excluding exercise ( ACOG guideline)
- Interested in the study after 18 weeks or pregnancy
- Not availability to attend to the physical exercise program
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital of Torrejonlead
- Universidad Politecnica de Madridcollaborator
Study Sites (1)
University Hospital de Torrejon
Torrejón de Ardoz, Madrid, 28850, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ruben Barakat
Universidad Politecnica de Madrid
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
April 21, 2016
First Posted
April 29, 2016
Study Start
November 1, 2014
Primary Completion
December 1, 2016
Study Completion
February 1, 2017
Last Updated
October 27, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share