Physical Exercise Program in Obese and Overweight Pregnant Women

NCT ID: NCT01753622

Last Updated: 2014-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2015-11-30

Brief Summary

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Obesity and overweight have become an epidemic in the world and its prevalence between pregnant women is especially dangerous. Having a high Body Mass Index (BMI) is also associated with depression disorders and its serious complications during this period.

Detailed Description

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The aim of our study is to assess whether a specific exercise program during pregnancy has a positive effect on maternal mood and other pregnancy outcomes.

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control group

Sedentary Obese and overweight pregnant women

Group Type NO_INTERVENTION

No interventions assigned to this group

Exercise group

Physical exercise program

Group Type EXPERIMENTAL

Exercise group

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
* Having a Body Mass Index (BMI) greater than 24.9

Exclusion Criteria

* Multiparity
* Obstetrician complications
* Being interested in the study after 18 weeks
* Not being regular in physical exercise program (minimum adherence 80%)
* Younger than 18 years old
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Technical University of Madrid

OTHER

Sponsor Role lead

Responsible Party

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María Perales Santaella

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rubén Barakat, PhD

Role: STUDY_DIRECTOR

Universidad Politecnica de Madrid

Locations

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Universidad Politecnica de Madrid

Madrid, Madrid, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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María Perales, PhD student

Role: CONTACT

913364081

Ruben Barakat, PhD

Role: CONTACT

913364020

Facility Contacts

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Maria Perales, PhD student

Role: primary

913364081

Ruben Barakat, PhD

Role: backup

913364020

Other Identifiers

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Overweight-obese pregnant

Identifier Type: -

Identifier Source: org_study_id