Effect of Physical Exercise Program on Fetoplacental Growth

June 24, 2019 updated by: Marina Vargas Terrones, Universidad Politecnica de Madrid

Effect of Physical Exercise Program on Fetoplacental Growth: a Randomized Controlled Trial

The aim of this study is to examine the effect of a supervised physical exercise program during pregnancy on fetoplacental growth.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

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 Locations

  • Spain
      • Madrid, Spain, 28040
        • Universidad Politecnica de Madrid

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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 Torrejón, Hospital Universitario de Puerta de Hierro or Hospital Universitario Severo Ochoa (Madrid)

Exclusion Criteria:

  • Multiparity
  • Obstetrician complications
  • Being interested in the study after 18 weeks
  • Not having availability to attend to the physical exercise program
  • Younger than 18 years old
  • Older than 45 years old

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Pregnant women not participating in supervised physical exercise program. The subjects in this group will be monitored during pregnancy to know if they make any kind of exercise on your own, to know which are really sedentary pregnant women.
Experimental: Exercise Group
Pregnant women participating in supervised physical exercise program.
Behavioral: Exercise Group

Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (before week 16 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.

Other Names:
  • Supervised physical exercise program group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Placental weight
Time Frame: At delivery
At delivery
Fetal birth weight
Time Frame: At delivery
At delivery
Change from baseline in maternal gestational weight
Time Frame: 38-42 weeks of gestation
Maternal weight gain during pregnancy. Weight will be measured at the beginning and at the end of the pregnancy
38-42 weeks of gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregestational weight and Body Mass Index (BMI)
Time Frame: Before pregnancy
Before pregnancy
pH umbilical cord
Time Frame: At delivery
At delivery
Fetal size outcomes
Time Frame: At delivery
Size and height, head circumference and body mass index of the baby
At delivery
Fetal glycemia level
Time Frame: At delivery
At delivery
Apgar score
Time Frame: At delivery
Apgar score will be valued 1 and 5 minutes after delivery
At delivery
Maternal delivery outcomes (composite)
Time Frame: At delivery
Type of labor, stage and duration of labor
At delivery
Postpartum depression
Time Frame: 0-12 postpartum months
The level of maternal depression after delivery will be measured with the Edinburgh Postnatal Depression Scale (EPDS)
0-12 postpartum months
Changes from baseline in prenatal depression
Time Frame: Up to 36 weeks
The level of maternal depression during pregnancy will be measured at the beginning and at the end of the pregnancy, as well as at 8 weeks postpartum, with the Center for Epidemiologic Studies Depression Scale (CES-D)
Up to 36 weeks
Changes from baseline in maternal quality of life
Time Frame: Up to 36 weeks
Maternal quality of life will be measured at the beginning and at the end of the pregnancy, as well as at 8 weeks postpartum, with the Short Form-36 Health Survey (SF-36)
Up to 36 weeks
Changes from baseline in urinary incontinence
Time Frame: Up to 36 weeks
Urinary incontinence will be measured at the beginning and at the end of the pregnancy, as well as at 8 weeks postpartum, with the International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF)
Up to 36 weeks
Gestational diabetes
Time Frame: 24-28 weeks
Gestational diabetes will be measured with the O' Sullivan's test
24-28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Politecnica de Madrid

Investigators

  • Study Director: Rubén Barakat Carballo, PhD, Universidad Politécnica de Madrid.

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.

General Publications

Helpful Links

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

November 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

April 8, 2015

First Submitted That Met QC Criteria

April 16, 2015

First Posted (Estimate)

April 17, 2015

Study Record Updates

Last Update Posted (Actual)

June 25, 2019

Last Update Submitted That Met QC Criteria

June 24, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • INEF-001

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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