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
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|
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|
|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|
No Intervention: Control group
Sedentary pregnant women
Experimental: Exercise group
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.
- 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
- Maternal outcome [ Time Frame: Time spending in each stages of labor ]Time of stages of labor (min)
- Fetal outcome [ Time Frame: 1-5 minutes after labor ]Apgar score
- Maternal outcome [ Time Frame: Between 12 and 38 weeks ]Constipation (yes/not)
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
|Contact: Maria Perales, PhD email@example.com|
|Contact: Ruben Barakat, PhDfirstname.lastname@example.org|
|Universidad Politecnica de Madrid||Recruiting|
|Madrid, Spain, 28040|
|Contact: Maria Perales, PhD student 913364081 email@example.com|
|Study Director:||Ruben Barakat, PhD||Universidad Politecnica de Madrid|