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Clinical Trials/NCT01696201
NCT01696201
Unknown
Not Applicable

Effect of a Supervised Exercise Program During Whole Pregnancy on Outcomes and Level of Depression. A Randomized Controlled Trial

Technical University of Madrid1 site in 1 country160 target enrollmentOctober 2009
ConditionsPregnancy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy
Sponsor
Technical University of Madrid
Enrollment
160
Locations
1
Primary Endpoint
Change from level of depression at the end of the pregnancy
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2009
End Date
June 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

María Perales Santaella

PhD student

Technical University of Madrid

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change from level of depression at the end of the pregnancy

Time Frame: 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 Outcomes

  • Fetal outcome(1-5 minutes after labor)
  • Maternal outcome(Time spending in each stages of labor)

Study Sites (1)

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