Effect of Physical Exercise Program on Outcomes and Level of Depression

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

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.

Study Overview

• Status: Unknown
• Conditions: Pregnancy
• Intervention / Treatment: Behavioral: Exercise group

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.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Recruiting
    • Universidad Politecnica de Madrid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal outcome	Constipation (yes/not)	Between 12 and 38 weeks

Collaborators and Investigators

• Sponsor: Technical University of Madrid
• Investigators: Study Director: Ruben Barakat, PhD, Universidad Politecnica de Madrid

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): May 1, 2013
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: September 17, 2012
• First Submitted That Met QC Criteria: September 25, 2012
• First Posted (Estimate): September 28, 2012

Study Record Updates

• Last Update Posted (Estimate): November 14, 2014
• Last Update Submitted That Met QC Criteria: November 13, 2014
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Pregnancy, outcomes, depression, mood, physical exercise
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: Pregnancy outcomes