Exercise During Pregnancy and Perinatal Outcome

NCT ID: NCT02756143

Last Updated: 2017-10-27

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Effect of Physical Exercise Program on fetoplacental circulation and perinatal outcome.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The aim of this study is to examine the effect of a supervised physical exercise program during pregnancy on fetoplacental circulation, fetal heart echocardiogram parameters and perinatal outcome.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy Healthy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

fetal heart cesarean section exercise pregnancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Group

Non- supervised physical exercise program during pregnancy

Group Type NO_INTERVENTION

No interventions assigned to this group

Exercise Group

Supervised physical exercise program during pregnancy

Group Type EXPERIMENTAL

Exercise

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 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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exercise

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 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

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
* Able to communicate in spanish
* Giving birth at Torrejon Universitary Hospital

Exclusion Criteria

* Medical or obstetric complication excluding exercise ( ACOG guideline)
* Interested in the study after 18 weeks or pregnancy
* Not availability to attend to the physical exercise program
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidad Politecnica de Madrid

OTHER

Sponsor Role collaborator

University Hospital of Torrejon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Maia Brik

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ruben Barakat

Role: PRINCIPAL_INVESTIGATOR

Universidad Politecnica de Madrid

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital de Torrejon

Torrejón de Ardoz, Madrid, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PERINATEXER

Identifier Type: -

Identifier Source: org_study_id