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Effect During Pregnancy and Intrapartum Health

NCT ID: NCT03348332

Last Updated: 2017-11-20

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

COMPLETED

Clinical Phase

NA

Total Enrollment

530 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2016-09-30

Brief Summary

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Assessing the role of moderate exercise in newborn intrapartum variables have showed to be crucial not only on prescribing exercise safely, but also on understanding its impact on the prevention of some cardio-metabolic diseases after labor. Clarify this concept will be essential on reducing human risk for some chronic diseases through implementing supervised exercise programs during such a critical period.

Detailed Description

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The aim of this randomized controlled trial was to evaluate the effect of combined exercise (aerobic and strength exercise) on maternal and newborn intrapartum variables.

Conditions

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Pregnancy

Keywords

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exercise intrapartum aerobic exercise resistance exercise wellbeing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Sedentary pregnant women

Pregnant women who do not exercise regularly during pregnancy

Group Type NO_INTERVENTION

No interventions assigned to this group

Exercise pregnant women

Pregnant women who participate in a supervised exercise program

Group Type EXPERIMENTAL

Exercise pregnant women

Intervention Type BEHAVIORAL

A supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 10 to 39) was conducted. Each session consisted 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 during the training sessions to control the intensity.

Interventions

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Exercise pregnant women

A supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 10 to 39) was conducted. Each session consisted 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 during the training sessions to control the intensity.

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 Puerta de Hierro (Majadahonda); Hospital Universitario Severo Ochoa (Leganés).

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
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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ruben Barakat Carballo, PhD

Role: STUDY_DIRECTOR

Universidad Politecnica de Madrid

María Perales Santaella, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Politecnica de Madrid

Locations

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Universidad Politécnica de Madrid

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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Intrapartum assessment

Identifier Type: -

Identifier Source: org_study_id