Effect of Physical Exercise Program on Outcomes and Level of Depression

Study 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.

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

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Behavioral: Exercise group


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Sedentary pregnant women | |
| Experimental: Exercise group<br>Exercise program | Behavioral: Exercise group<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from level of depression at the end of the pregnancy | 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 | Up to 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal outcome | Time of stages of labor (min) | Time spending in each stages of labor | 
| Fetal outcome | Apgar score | 1-5 minutes after labor | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy, outcomes, depression, mood, physical exercise