Effect of Physical Exercise Program on Fetoplacental Growth

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: Healthy; Pregnancy
• Intervention / Treatment: Behavioral: Exercise Group

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Universidad Politécnica de Madrid

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

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		At delivery
Fetal birth weight		At delivery
Change from baseline in maternal gestational weight	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)		Before pregnancy
pH umbilical cord		At delivery
Fetal size outcomes	Size and height, head circumference and body mass index of the baby	At delivery
Fetal glycemia level		At delivery
Apgar score	Apgar score will be valued 1 and 5 minutes after delivery	At delivery
Maternal delivery outcomes (composite)	Type of labor, stage and duration of labor	At delivery
Postpartum depression	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	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	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	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	Gestational diabetes will be measured with the O' Sullivan's test	24-28 weeks

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.
• Vargas-Terrones M, Barakat R, Santacruz B, Fernandez-Buhigas I, Mottola MF. Physical exercise programme during pregnancy decreases perinatal depression risk: a randomised controlled trial. Br J Sports Med. 2019 Mar;53(6):348-353. doi: 10.1136/bjsports-2017-098926. Epub 2018 Jun 13.
• Barakat R, Vargas M, Brik M, Fernandez I, Gil J, Coteron J, Santacruz B. Does Exercise During Pregnancy Affect Placental Weight?: A Randomized Clinical Trial. Eval Health Prof. 2018 Sep;41(3):400-414. doi: 10.1177/0163278717706235. Epub 2017 Apr 25.

Helpful Links

• Website that provides information about our research group projects

Study record dates

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: Pregnancy; Physical exercise; Pregnant; Fetoplacental growth; Placental development; Active pregnancy
• Other Study ID Numbers: INEF-001