Effect of Regular Exercise on Maternal Cardiovascular System During Pregnancy
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|ClinicalTrials.gov Identifier: NCT01723098|
Recruitment Status : Unknown
Verified March 2014 by María Perales Santaella, Technical University of Madrid.
Recruitment status was: Recruiting
First Posted : November 7, 2012
Last Update Posted : November 14, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy||Behavioral: Exercise group||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Effect of Supervised Exercise Program on Cardiovascular Function and Structure in Pregnant Women. Randomized Controlled Trial|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||September 2015|
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.
- 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
- Change from cardiovascular structure at the end of the pregnancy [ Time Frame: Weeks 20 and 34 ]Data were collected in second and third trimester
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01723098
|Contact: Maria Perales, PhD firstname.lastname@example.org|
|Contact: Ruben Barakat, PhDemail@example.com|
|Universidad Politecnica de Madrid||Recruiting|
|Madrid, Spain, 28040|
|Contact: Maria Perales, PhD student 913364081 firstname.lastname@example.org|
|Contact: Ruben Barakat, PhD 913364120 email@example.com|
|Principal Investigator: Maria Perales, PhD student|
|Study Director:||Ruben Barakat, PhD||Universidad Politecnica de Madrid|