Effect of Physical Exercise Program on Fetoplacental Growth

Sponsor

Universidad Politecnica de Madrid (Other)

Overall Status

Unknown status

CT.gov ID

NCT02420288

Collaborator

(none)

124

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Healthy	Behavioral: Exercise Group	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Nov 1, 2014

Actual Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Pregestational weight and Body Mass Index (BMI) [Before pregnancy]
pH umbilical cord [At delivery]
Fetal size outcomes [At delivery]
Size and height, head circumference and body mass index of the baby
Fetal glycemia level [At delivery]
Apgar score [At delivery]
Apgar score will be valued 1 and 5 minutes after delivery
Maternal delivery outcomes (composite) [At delivery]
Type of labor, stage and duration of labor
Postpartum depression [0-12 postpartum months]
The level of maternal depression after delivery will be measured with the Edinburgh Postnatal Depression Scale (EPDS)
Changes from baseline in prenatal depression [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)
Changes from baseline in maternal quality of life [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)
Changes from baseline in urinary incontinence [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)
Gestational diabetes [24-28 weeks]
Gestational diabetes will be measured with the O' Sullivan's test

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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)