Effect of Physical Exercise Program on Outcomes and Level of Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Technical University of Madrid.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
María Perales Santaella, Technical University of Madrid
ClinicalTrials.gov Identifier:
NCT01696201
First received: September 17, 2012
Last updated: February 6, 2013
Last verified: September 2012
  Purpose

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 Intervention
Pregnancy
Behavioral: Exercise group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Technical University of Madrid:

Primary Outcome Measures:
  • Change from level of depression at the end of the pregnancy [ Time Frame: Up to 36 weeks ] [ Designated as safety issue: No ]
    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:
  • Maternal outcome [ Time Frame: Time spending in each stages of labor ] [ Designated as safety issue: No ]
    Time of stages of labor (min)

  • Fetal outcome [ Time Frame: 1-5 minutes after labor ] [ Designated as safety issue: No ]
    Apgar score


Other Outcome Measures:
  • Maternal outcome [ Time Frame: Between 12 and 38 weeks ] [ Designated as safety issue: No ]
    Constipation (yes/not)


Estimated Enrollment: 160
Study Start Date: October 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: María Perales Santaella, PhD student, Technical University of Madrid
ClinicalTrials.gov Identifier: NCT01696201     History of Changes
Other Study ID Numbers: Pregnancy outcomes
Study First Received: September 17, 2012
Last Updated: February 6, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014