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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01696201
Enrollment
160
Registered
2012-09-28
Start date
2009-10-31
Completion date
2015-06-30
Last updated
2014-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Pregnancy, outcomes, depression, mood, physical exercise

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.

Interventions

BEHAVIORALExercise 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.

Sponsors

Technical University of Madrid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from level of depression at the end of the pregnancyUp to 36 weeksThe Center for Epidemiological Studies-Depression scale (CES-D) was administered to all pregnant women at the beginning and at the end of their pregnancies

Secondary

MeasureTime frameDescription
Maternal outcomeTime spending in each stages of laborTime of stages of labor (min)
Fetal outcome1-5 minutes after laborApgar score

Other

MeasureTime frameDescription
Maternal outcomeBetween 12 and 38 weeksConstipation (yes/not)

Countries

Spain

Contacts

Primary ContactMaria Perales, PhD student
m.perales.santaella@gmail.com913364081
Backup ContactRuben Barakat, PhD
barakatruben@gmail.com913364020

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026