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Effect of Physical Exercise Program on Outcomes and Level of Depression

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ClinicalTrials.gov Identifier: NCT01696201
Recruitment Status : Unknown
Verified September 2012 by María Perales Santaella, Technical University of Madrid.
Recruitment status was:  Recruiting
First Posted : September 28, 2012
Last Update Posted : November 14, 2014
Sponsor:
Information provided by (Responsible Party):
María Perales Santaella, 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.


Condition or disease Intervention/treatment Phase
Pregnancy Behavioral: Exercise group Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effect of a Supervised Exercise Program During Whole Pregnancy on Outcomes and Level of Depression. A Randomized Controlled Trial
Study Start Date : October 2009
Actual Primary Completion Date : May 2013
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control group
Sedentary pregnant women
Experimental: Exercise group
Exercise program
Behavioral: Exercise group

Supervised physical conditioning program of three 55—60 minute sessions per week during whole pregnancy (from week 9 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 maximal heart rate. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate.





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Maternal outcome [ Time Frame: Time spending in each stages of labor ]
    Time of stages of labor (min)

  2. Fetal outcome [ Time Frame: 1-5 minutes after labor ]
    Apgar score


Other Outcome Measures:
  1. Maternal outcome [ Time Frame: Between 12 and 38 weeks ]
    Constipation (yes/not)



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01696201


Contacts
Contact: Maria Perales, PhD student 913364081 m.perales.santaella@gmail.com
Contact: Ruben Barakat, PhD 913364020 barakatruben@gmail.com

Locations
Spain
Universidad Politecnica de Madrid Recruiting
Madrid, Spain, 28040
Contact: Maria Perales, PhD student    913364081    m.perales.santaella@gmail.com   
Sponsors and Collaborators
Technical University of Madrid
Investigators
Study Director: Ruben Barakat, PhD Universidad Politecnica de Madrid

Responsible Party: María Perales Santaella, PhD student, Technical University of Madrid
ClinicalTrials.gov Identifier: NCT01696201     History of Changes
Other Study ID Numbers: Pregnancy outcomes
First Posted: September 28, 2012    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: September 2012

Keywords provided by María Perales Santaella, Technical University of Madrid:
Pregnancy, outcomes, depression, mood, physical exercise

Additional relevant MeSH terms:
Depression
Behavioral Symptoms