Effect of Regular Exercise on Maternal Cardiovascular System During Pregnancy

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01723098
• Other study ID #: Maternal cardiovascular system
• Status: Recruiting
• Phase: N/A
• First received: November 5, 2012
• Last updated: November 13, 2014
• Start date: February 2009
• Est. completion date: September 2015

Study information

• Verified date: March 2014
• Source: Technical University of Madrid
• Contact: Maria Perales, PhD student
• Phone: 913364081
• Email: m.perales.santaella[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: September 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
Spain	Universidad Politecnica de Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Technical University of Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from cardiovascular function at the end of pregnancy: Stroke volume	Data were collected in second and third trimester	Weeks 20 and 34	No
Primary	Change from cardiovascular structure at the end of the pregnancy	Data were collected in second and third trimester	Weeks 20 and 34	No
Secondary	Maternal and fetal pregnancy outcomes	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.	No