Physical Exercise Controls Gestational Weight Gain

NCT ID: NCT01790347

Last Updated: 2013-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2011-06-30

Brief 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..

Detailed 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.

Conditions

Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Exercise group

Group Type: EXPERIMENTAL

Exercise group

Intervention Type: BEHAVIORAL

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.

Control group

Sedentary pregnant women

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Technical University of Madrid

OTHER

Sponsor Role: lead

Responsible Party

María Perales Santaella

PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ruben Barakat, PhD

Role: STUDY_DIRECTOR

Universidad Politecnica de Madrid

Locations

Universidad Politécnica de Madrid

Madrid, Madrid, Spain

Countries

Spain

References

Ruiz JR, Perales M, Pelaez M, Lopez C, Lucia A, Barakat R. Supervised exercise-based intervention to prevent excessive gestational weight gain: a randomized controlled trial. Mayo Clin Proc. 2013 Dec;88(12):1388-97. doi: 10.1016/j.mayocp.2013.07.020.

Reference Type: DERIVED

PMID: 24290112 (View on PubMed)

Other Identifiers

Gestational weight gain

Identifier Type: -

Identifier Source: org_study_id