NCT02420288

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

2.1 years

First QC Date

April 8, 2015

Last Update Submit

June 24, 2019

Conditions

PregnancyHealthy

Keywords

PregnancyFetoplacental growthPhysical exercisePregnantPlacental developmentActive pregnancy

Outcome Measures

Primary Outcomes (3)

  • Placental weight

    At delivery

  • Fetal birth weight

    At delivery

  • Change from baseline in maternal gestational weight

    Maternal weight gain during pregnancy. Weight will be measured at the beginning and at the end of the pregnancy

    38-42 weeks of gestation

Secondary Outcomes (11)

  • Pregestational weight and Body Mass Index (BMI)

    Before pregnancy

  • pH umbilical cord

    At delivery

  • Fetal size outcomes

    At delivery

  • Fetal glycemia level

    At delivery

  • Apgar score

    At delivery

  • +6 more secondary outcomes

Study Arms (2)

Control Group

NO INTERVENTION

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.

Exercise Group

EXPERIMENTAL

Pregnant women participating in supervised physical exercise program.

Behavioral: Exercise Group

Interventions

Exercise GroupBEHAVIORAL

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.

Also known as: Supervised physical exercise program group
Exercise Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Politécnica de Madrid

Madrid, 28040, Spain

Location

Related Publications (3)

  • 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.

    PMID: 32378735DERIVED

  • 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.

    PMID: 29899050DERIVED

  • 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.

    PMID: 29179559DERIVED

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Rubén Barakat Carballo, PhD

    Universidad Politecnica de Madrid

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

April 8, 2015

First Posted

April 17, 2015

Study Start

November 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2021

Last Updated

June 25, 2019

Record last verified: 2019-06

Locations

ES(1)