Effect of Physical Exercise Program on Fetoplacental Growth

NCT ID: NCT02420288

Last Updated: 2019-06-25

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

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2021-12-31

Brief Summary

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The aim of this study is to examine the effect of a supervised physical exercise program during pregnancy on fetoplacental growth.

Detailed Description

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Conditions

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Pregnancy Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Control Group

Pregnant women not participating in supervised physical exercise program. The subjects in this group will be monitored during pregnancy to know if they make any kind of exercise on your own, to know which are really sedentary pregnant women.

Group Type NO_INTERVENTION

No interventions assigned to this group

Exercise Group

Pregnant women participating in supervised 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 (before week 16 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 heart rate reserve. 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 (before week 16 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 heart rate reserve. 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

Other Intervention Names

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Supervised physical exercise program group

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 Torrejón, Hospital Universitario de Puerta de Hierro or Hospital Universitario Severo Ochoa (Madrid)

Exclusion Criteria

* Multiparity
* Obstetrician complications
* Being interested in the study after 18 weeks
* Not having availability to attend to the physical exercise program
* Younger than 18 years old
* Older than 45 years old
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Politecnica de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Marina Vargas Terrones

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rubén Barakat Carballo, PhD

Role: STUDY_DIRECTOR

Universidad Politecnica de Madrid

Locations

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Universidad Politécnica de Madrid

Madrid, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 32378735 (View on PubMed)

Vargas-Terrones M, Barakat R, Santacruz B, Fernandez-Buhigas I, Mottola MF. Physical exercise programme during pregnancy decreases perinatal depression risk: a randomised controlled trial. Br J Sports Med. 2019 Mar;53(6):348-353. doi: 10.1136/bjsports-2017-098926. Epub 2018 Jun 13.

Reference Type DERIVED
PMID: 29899050 (View on PubMed)

Barakat R, Vargas M, Brik M, Fernandez I, Gil J, Coteron J, Santacruz B. Does Exercise During Pregnancy Affect Placental Weight?: A Randomized Clinical Trial. Eval Health Prof. 2018 Sep;41(3):400-414. doi: 10.1177/0163278717706235. Epub 2017 Apr 25.

Reference Type DERIVED
PMID: 29179559 (View on PubMed)

Related Links

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http://afipe.es/embarazo-y-ejercicio.html

Website that provides information about our research group projects

Other Identifiers

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INEF-001

Identifier Type: -

Identifier Source: org_study_id

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