Effect of Physical Exercise Program on Outcomes and Level of Depression

Not Applicable

• Conditions: Pregnancy
• Interventions: Behavioral: Exercise group

• Registration Number: NCT01696201
• Lead Sponsor: Technical University of Madrid

Brief Summary

Due to physical and physiological changes that occur in pregnant women, depression is very common during this period. Recent research findings indicate that antenatal maternal mood state impacts on babies health. Nowadays, many researchers are focussed on examining the effects of physical exercise on foetal and maternal outcomes.

The main aim of this study was to assess the effectiveness of a supervised exercise program consisted of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvis floor muscles training, on the prevention and treatment of depression in pregnant women. Additionally, the other purpose of the study was to analyze the effects of depression and physical exercise on outcomes.

Hypothesis: Pregnant women who do regular exercise during their pregnancies would have a better mood state than pregnant women who are sedentary, without having any negative effect on outcomes.

Detailed Description

BACKROUND: Recent studies have estimated the prevalence of depression during pregnancy at between 10% and 30%. This state can produce negative effects on the fetus as:

* Affect cerebral development

* Increase the risk of preterm birth and low birth weight

* Increase the risk of childhood overweight problems

* Adverse impact on the cognitive, emotional, social, and behavioural development of infants

Due to the possible side effect of antidepressants on mother and fetus, its necessary to examine alternative solutions to this state.

Study Timeline

• Study Start: 2009-10
• Status Verified: 2012-09
• Study First Submitted: 2012-09-17
• Study First Submitted QC: 2012-09-25
• Study First Posted: 2012-09-28
• Primary Completion: 2013-05
• Last Update Submitted: 2014-11-13
• Last Update Posted: 2014-11-14
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 160

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 Fuenlabrada

Exclusion Criteria

• Multiparity
• Obstetrician complications
• Being interested in the study after 18 weeks
• Not being regular in physical exercise program
• Younger than 18 years old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise group	Exercise group	Exercise program

Primary Outcome Measures

Name	Time	Method
Change from level of depression at the end of the pregnancy	Up to 36 weeks	The Center for Epidemiological Studies-Depression scale (CES-D) was administered to all pregnant women at the beginning and at the end of their pregnancies

Secondary Outcome Measures

Name	Time	Method
Fetal outcome	1-5 minutes after labor	Apgar score
Maternal outcome	Time spending in each stages of labor	Time of stages of labor (min)

Trial Locations

Locations (1)

Universidad Politecnica de Madrid; 🇪🇸 Madrid, Spain