Effect of Physical Exercise Program on Outcomes and Level of Depression
Primary Purpose
Pregnancy
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exercise group
Sponsored by
About this trial
This is an interventional health services research trial for Pregnancy focused on measuring Pregnancy, outcomes, depression, mood, physical exercise
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
Sites / Locations
- Universidad Politecnica de MadridRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Exercise group
Arm Description
Sedentary pregnant women
Exercise program
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Maternal outcome
Time of stages of labor (min)
Fetal outcome
Apgar score
Full Information
NCT ID
NCT01696201
First Posted
September 17, 2012
Last Updated
November 13, 2014
Sponsor
Technical University of Madrid
1. Study Identification
Unique Protocol Identification Number
NCT01696201
Brief Title
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
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technical University of Madrid
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy
Keywords
Pregnancy, outcomes, depression, mood, physical exercise
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Sedentary pregnant women
Arm Title
Exercise group
Arm Type
Experimental
Arm Description
Exercise program
Intervention Type
Behavioral
Intervention Name(s)
Exercise group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from level of depression at the end of the pregnancy
Description
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
Time Frame
Up to 36 weeks
Secondary Outcome Measure Information:
Title
Maternal outcome
Description
Time of stages of labor (min)
Time Frame
Time spending in each stages of labor
Title
Fetal outcome
Description
Apgar score
Time Frame
1-5 minutes after labor
Other Pre-specified Outcome Measures:
Title
Maternal outcome
Description
Constipation (yes/not)
Time Frame
Between 12 and 38 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Perales, PhD student
Phone
913364081
Email
m.perales.santaella@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ruben Barakat, PhD
Phone
913364020
Email
barakatruben@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruben Barakat, PhD
Organizational Affiliation
Universidad Politecnica de Madrid
Official's Role
Study Director
Facility Information:
Facility Name
Universidad Politecnica de Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Perales, PhD student
Phone
913364081
Email
m.perales.santaella@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
32378735
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.
Results Reference
derived
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Effect of Physical Exercise Program on Outcomes and Level of Depression
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