Physical Exercise Controls Gestational Weight Gain

Pregnancy Clinical Trial

Official title:

The Role of a Supervised Physical Exercise Program as a Alternative on the Control of Maternal Gestational Weight Gain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01790347
• Other study ID #: Gestational weight gain
• Status: Completed
• Phase: N/A
• First received: February 4, 2013
• Last updated: March 13, 2013
• Start date: September 2007
• Est. completion date: June 2011

Study information

• Verified date: January 2013
• Source: Technical University of Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

An estimated two-thirds to three- quarters of women experience gestational weight gain outside of IOM's 2009 recommendations: 40-60% of women experiencing excessive gain and 15-30% inadequate gain. Not gaining the adequate weight gain is strongly associated with several maternal and fetal complications..

Description:

The aim of this study was to assess the role of a supervised exercise programme on the control of maternal gestational weight gain and its consequences.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2350
• Est. completion date: June 2011
• Est. primary completion date: January 2011
• 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

Exclusion Criteria:

• 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: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pregnancy
• Weight Gain

Intervention

Behavioral:
• Exercise group
The physical conditioning program included a total of three 50-55 minute sessions per week. Pregnant women started at 9 weeks and finished at 38-39 weeks, therefore, an average of 85 training sessions were planned for each participant. All subjects wore a heart rate (HR) monitor (Polar FT7, Finland) during the training sessions to ensure that the exercise intensity was light to moderate. Each session included 10 min of warm up and 10 min of cool down which included an specific pelvic floor muscles training. The core section of the exercise session lasted from 25 to 30 min and included moderate-intensity aerobic exercises once a week and resistance exercises twice a week.

Locations

Country	Name	City	State
Spain	Universidad Politécnica 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
Other	Gestational age	Number of weeks of gestation at labor	36-42 weeks	No
Other	Fetal outcome	Type of labor	36-42 weeks	No
Primary	Maternal gestational weight gain	Maternal weight gain	40-42 weeks	No
Secondary	Maternal gestational diabetes	Gestational diabetes	From 24 to 26 week	No
Secondary	Fetal body mass index	Baby body Mass index (BMI)	38-42 weeks	No