Effect of Regular Exercise on Maternal Cardiovascular System During Pregnancy

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Technical University of Madrid
Sponsor:
Information provided by (Responsible Party):
María Perales Santaella, Technical University of Madrid
ClinicalTrials.gov Identifier:
NCT01723098
First received: November 5, 2012
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Pregnancy
Behavioral: Exercise group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Effect of Supervised Exercise Program on Cardiovascular Function and Structure in Pregnant Women. Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Technical University of Madrid:

Primary Outcome Measures:
  • Change from cardiovascular function at the end of pregnancy: Stroke volume [ Time Frame: Weeks 20 and 34 ] [ Designated as safety issue: No ]
    Data were collected in second and third trimester

  • Change from cardiovascular structure at the end of the pregnancy [ Time Frame: Weeks 20 and 34 ] [ Designated as safety issue: No ]
    Data were collected in second and third trimester


Secondary Outcome Measures:
  • Maternal and fetal pregnancy outcomes [ Time Frame: During pregnancy. At the moment of delivery. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 800
Study Start Date: February 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Sedentary pregnant women
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.


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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01723098

Contacts
Contact: Maria Perales, PhD student 913364081 m.perales.santaella@gmail.com
Contact: Ruben Barakat, PhD 913364120 barakatruben@gmail.com

Locations
Spain
Universidad Politecnica de Madrid Recruiting
Madrid, Spain, 28040
Contact: Maria Perales, PhD student    913364081    m.perales.santaella@gmail.com   
Contact: Ruben Barakat, PhD    913364120    barakatruben@gmail.com   
Principal Investigator: Maria Perales, PhD student         
Sponsors and Collaborators
Technical University of Madrid
Investigators
Study Director: Ruben Barakat, PhD Universidad Politecnica de Madrid
  More Information

No publications provided

Responsible Party: María Perales Santaella, PhD Student, Technical University of Madrid
ClinicalTrials.gov Identifier: NCT01723098     History of Changes
Other Study ID Numbers: Maternal cardiovascular system
Study First Received: November 5, 2012
Last Updated: March 5, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Technical University of Madrid:
Pregnancy, cardiovascular system, physical exercise

ClinicalTrials.gov processed this record on July 23, 2014