Effect of Physical Exercise Program on Outcomes and Level of Depression

Technical University of Madrid

Status: Unknown

Conditions: Pregnancy

Treatments: Behavioral: Exercise group

Study type: Interventional

Funder types: Other

Identifiers

NCT01696201

Pregnancy outcomes

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Control group

No Intervention group

Description:

Sedentary pregnant women

Exercise group

Experimental group

Description:

Exercise program

Treatment:

Behavioral: Exercise group