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Regular Aquatic Activities and Pregnancy Outcomes (aquapreg)

Primary Purpose

Weight Gain

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Aquatic activities intervention
Sponsored by
Universidad Politecnica de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Weight Gain focused on measuring Aquatic activities, Aerobic exercise, Resistance exercise, Pregnancy, Maternal weight gain, birthweight

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy pregnant women without any medical or obstetric complication to practice moderate exercise
  • Being able to communicate in Spanish

Exclusion Criteria:

  • Being interesting in the study after 16 weeks of gestation
  • Having obstetric contraindications
  • Not attended regular to the exercise program

Sites / Locations

  • Thecnical University of MadridRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

The aquatic exercise program included a total of three 50-55 minutes session per week. Pregnant women started at 9 weeks and finished at 38-39 weeks. Each session included 10 minutes of warm up and 10 minutes of cool down including an specific pelvic floor muscle training. The core section of the session included aerobic and strength moderate exercise in water during 25 to 30 minutes

Sedentary healthy pregnant women

Outcomes

Primary Outcome Measures

Maternal gestational weight gain
Maternal weight gain was collected at the end of pregnancy as well as before getting pregnant (pre-gestational weight gain)
Birthweight
Birth weight was collected at delivery

Secondary Outcome Measures

Number of participants with adverse pregnancy outcomes as assessed by medical records
Other health baby outcomes at delivery
Gestational age
Gestational age of pregnancy
Maternal blood pressure and gestational diabetes as assessed by medical records
Blood pressure, gestational diabetes...

Full Information

First Posted
October 30, 2015
Last Updated
November 9, 2015
Sponsor
Universidad Politecnica de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT02602106
Brief Title
Regular Aquatic Activities and Pregnancy Outcomes
Acronym
aquapreg
Official Title
Effects of Regular Aquatic Activities on Pregnancy Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Politecnica de Madrid

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Aquatic activities is one of the most attractive physical exercise during pregnancy, especially during the third trimester.
Detailed Description
The aim of this study was to evaluate the effect of moderate regular aquatic exercise during pregnancy on maternal and fetus outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain
Keywords
Aquatic activities, Aerobic exercise, Resistance exercise, Pregnancy, Maternal weight gain, birthweight

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The aquatic exercise program included a total of three 50-55 minutes session per week. Pregnant women started at 9 weeks and finished at 38-39 weeks. Each session included 10 minutes of warm up and 10 minutes of cool down including an specific pelvic floor muscle training. The core section of the session included aerobic and strength moderate exercise in water during 25 to 30 minutes
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Sedentary healthy pregnant women
Intervention Type
Behavioral
Intervention Name(s)
Aquatic activities intervention
Intervention Description
Women were suggested to exercise regularly through aquatic activities. A professional in physical exercise and sports designed and conducted the aquatic exercise program.
Primary Outcome Measure Information:
Title
Maternal gestational weight gain
Description
Maternal weight gain was collected at the end of pregnancy as well as before getting pregnant (pre-gestational weight gain)
Time Frame
40-42 weeks
Title
Birthweight
Description
Birth weight was collected at delivery
Time Frame
37-42 weeks
Secondary Outcome Measure Information:
Title
Number of participants with adverse pregnancy outcomes as assessed by medical records
Description
Other health baby outcomes at delivery
Time Frame
37-42 weeks
Title
Gestational age
Description
Gestational age of pregnancy
Time Frame
37-42 weeks
Title
Maternal blood pressure and gestational diabetes as assessed by medical records
Description
Blood pressure, gestational diabetes...
Time Frame
9 to 42 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy pregnant women without any medical or obstetric complication to practice moderate exercise Being able to communicate in Spanish Exclusion Criteria: Being interesting in the study after 16 weeks of gestation Having obstetric contraindications Not attended regular to the exercise program
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rubén O Barakat Carballo, PhD
Phone
913364120
Ext
4120
Email
barakatruben@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mariano Bacchi
Email
marianobacchi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruben Barakat Carballo, PhD
Organizational Affiliation
Technical University of Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thecnical University of Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rubén Barakat, PhD
Email
barakatruben@gmail.com
First Name & Middle Initial & Last Name & Degree
Mariano Bacchi
Email
marianobacchi@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
28279085
Citation
Bacchi M, Mottola MF, Perales M, Refoyo I, Barakat R. Aquatic Activities During Pregnancy Prevent Excessive Maternal Weight Gain and Preserve Birth Weight: A Randomized Clinical Trial. Am J Health Promot. 2018 Mar;32(3):729-735. doi: 10.1177/0890117117697520. Epub 2017 Mar 9.
Results Reference
derived

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Regular Aquatic Activities and Pregnancy Outcomes

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