Effect of Regular Exercise on Maternal Cardiovascular System During Pregnancy

November 13, 2014 updated by: María Perales Santaella, Technical University of Madrid

Effect of Supervised Exercise Program on Cardiovascular Function and Structure in Pregnant Women. Randomized Controlled Trial

The main aim of this study was to analysed the security of a supervised exercise program on maternal cardiovascular system and assess the positive effects of this program on maternal cardiovascular function and structure

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

During pregnancy, the effectiveness of cardiovascular system is necessary to the growth and development of the baby, however many changes in it occur during this period.

Physical exercise has shown to have a positive effect on cardiovascular structure and function in the general population.

Study Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Recruiting
        • Universidad Politecnica de Madrid
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 and Hospital Universitario Severo Ochoa (Madrid).

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise group
Behavioral: Exercise group

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 maximal heart rate. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate.
No Intervention: Control
Sedentary pregnant women

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from cardiovascular function at the end of pregnancy: Stroke volume
Time Frame: Weeks 20 and 34
Data were collected in second and third trimester
Weeks 20 and 34
Change from cardiovascular structure at the end of the pregnancy
Time Frame: Weeks 20 and 34
Data were collected in second and third trimester
Weeks 20 and 34

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal and fetal pregnancy outcomes
Time Frame: During pregnancy. At the moment of delivery.
Gestational age, type of delivery, duration of labor, maternal weight gain, birth weight, size and head circumference of new born, pH of umbilical cord, Apgar Score.
During pregnancy. At the moment of delivery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Madrid

Investigators

  • Study Director: Ruben Barakat, PhD, Universidad Politecnica de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

June 1, 2014

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

November 5, 2012

First Submitted That Met QC Criteria

November 5, 2012

First Posted (Estimate)

November 7, 2012

Study Record Updates

Last Update Posted (Estimate)

November 14, 2014

Last Update Submitted That Met QC Criteria

November 13, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Maternal cardiovascular system

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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