Clinical trial NCT01696201: Effect of Physical Exercise Program on Outcomes and Level of Depression
Official title: Effect of a Supervised Exercise Program During Whole Pregnancy on Outcomes and Level of Depression. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Keywords: Pregnancy, outcomes, depression, mood, physical exercise
Lead sponsor: Technical University of Madrid
Sponsor class: OTHER
First posted: 2012-09-28
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change from level of depression at the end of the pregnancy
timeFrame: Up to 36 weeks
Secondary outcomes:
measure: Maternal outcome
timeFrame: Time spending in each stages of labor
measure: Fetal outcome
timeFrame: 1-5 minutes after labor
Other outcomes:
measure: Maternal outcome
timeFrame: Between 12 and 38 weeks
Locations:
city: Madrid
country: Spain
facility: Universidad Politecnica de Madrid
Study officials:
affiliation: Universidad Politecnica de Madrid
name: Ruben Barakat, PhD
role: STUDY_DIRECTOR
References:
citation: Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.