NCT02602106

Brief Summary

Aquatic activities is one of the most attractive physical exercise during pregnancy, especially during the third trimester.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 11, 2015

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

November 11, 2015

Status Verified

October 1, 2015

Enrollment Period

1.3 years

First QC Date

October 30, 2015

Last Update Submit

November 9, 2015

Conditions

Keywords

Aquatic activitiesAerobic exerciseResistance exercisePregnancyMaternal weight gainbirthweight

Outcome Measures

Primary Outcomes (2)

  • Maternal gestational weight gain

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

    40-42 weeks

  • Birthweight

    Birth weight was collected at delivery

    37-42 weeks

Secondary Outcomes (3)

  • Number of participants with adverse pregnancy outcomes as assessed by medical records

    37-42 weeks

  • Gestational age

    37-42 weeks

  • Maternal blood pressure and gestational diabetes as assessed by medical records

    9 to 42 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Behavioral: Aquatic activities intervention

Control group

NO INTERVENTION

Sedentary healthy pregnant women

Interventions

Women were suggested to exercise regularly through aquatic activities. A professional in physical exercise and sports designed and conducted the aquatic exercise program.

Intervention group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thecnical University of Madrid

Madrid, Madrid, 28040, Spain

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Weight GainGestational Weight GainBirth Weight

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ruben Barakat Carballo, PhD

    Technical University of Madrid

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rubén O Barakat Carballo, PhD

CONTACT

Mariano Bacchi

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD in Physical Exercise and Sports Sciences

Study Record Dates

First Submitted

October 30, 2015

First Posted

November 11, 2015

Study Start

June 1, 2011

Primary Completion

September 1, 2012

Study Completion

June 1, 2017

Last Updated

November 11, 2015

Record last verified: 2015-10

Locations