Fetal Cardiovascular Response to Maternal Exercise During Third Trimester

NCT ID: NCT01723293

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

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2015-06-30

Brief Summary

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The purpose of this study was to examine the behavior of the fetal heart rate in response to different intensities of acute maternal exercise in training and non-training pregnant women

Detailed Description

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Fetal heart rate is considered an important index of fetal well-being, especially during the third trimester of pregnancy (Rodney JR, Huntley BJ, Rodney WM, 2012). An increase in the FHR of 5-25 beats per min (bpm) in response to maternal exercise has been established as a normal reaction(Riemann,Kanstrup Hansen, 2000)however the normal FHR response to maternal exercise has remained unclear for several reasons

Most of the studies are focused on obtain data in order to examine the fetal heart rate response to maternal exercise using cardiotocography measurements prior to and following maternal exercise

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control

Sedentary pregnant women

Group Type NO_INTERVENTION

No interventions assigned to this group

Exercise group

Group Type EXPERIMENTAL

Exercise group

Intervention Type BEHAVIORAL

The physical conditioning program included a total of three 55-60 minute sessions per week. Pregnant women started in 9-12 weeks and finished in 38-40 weeks, therefore, an average of 85 training sessions were planned for each participant. All subjects wore a heart rate (HR) monitor (Polar FT7, Finland) during the training sessions to ensure that the exercise intensity was light to moderate.

Each session included a 25-minutes of aerobic exercise, 10-minutes of strength exercise and balance exercise as well, and 10-minutes of pelvic floor muscles training.

Interventions

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Exercise group

The physical conditioning program included a total of three 55-60 minute sessions per week. Pregnant women started in 9-12 weeks and finished in 38-40 weeks, therefore, an average of 85 training sessions were planned for each participant. All subjects wore a heart rate (HR) monitor (Polar FT7, Finland) during the training sessions to ensure that the exercise intensity was light to moderate.

Each session included a 25-minutes of aerobic exercise, 10-minutes of strength exercise and balance exercise as well, and 10-minutes of pelvic floor muscles training.

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

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 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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Maria 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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Fetal responses to exercise

Identifier Type: -

Identifier Source: org_study_id