Back to resultsExercise During Pregnancy and Urinary Incontinence
Primary Purpose
Pregnancy, Healthy
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Supervised physical exercise program
Sponsored by
About this trial
This is an interventional prevention trial for Pregnancy focused on measuring Pregnancy, Physical exercise, Urinary incontinence
Eligibility Criteria
Inclusion Criteria:
- Healthy pregnant women
Exclusion Criteria:
-
Sites / Locations
- Universidad Politécnica de MadridRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Pregnant women receiving usual care and participating in supervised physical exercise program.
Pregnant women that are receiving usual care but are not participating in supervised physical exercise program.
Outcomes
Primary Outcome Measures
Urinary incontinence
Urinary incontinence was measured by the International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF).
Secondary Outcome Measures
Full Information
NCT ID
NCT03997045
First Posted
June 24, 2019
Last Updated
June 24, 2019
Sponsor
Universidad Politecnica de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT03997045
Brief Title
Exercise During Pregnancy and Urinary Incontinence
Official Title
Effect of Physical Exercise Program During Pregnancy on Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Anticipated)
Study Completion Date
July 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Politecnica de Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to examine the effect of a supervised physical exercise program during pregnancy on urinary incontinence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Healthy
Keywords
Pregnancy, Physical exercise, Urinary incontinence
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Pregnant women receiving usual care and participating in supervised physical exercise program.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Pregnant women that are receiving usual care but are not participating in supervised physical exercise program.
Intervention Type
Behavioral
Intervention Name(s)
Supervised physical exercise program
Intervention Description
Supervised physical conditioning program of two 60-minutes sessions per week during pregnancy, developed from gestational week 20 to 38. Each session consists of 25-30 minutes of cardiovascular exercise,15 minutes of strengthening exercises, 5 minutes of coordination and balance exercises and 10 minutes of pelvic floor muscles training.
Primary Outcome Measure Information:
Title
Urinary incontinence
Description
Urinary incontinence was measured by the International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF).
Time Frame
Gestational week 36-38
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
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marina Vargas Terrones, PhD
Phone
+34 91 336 41 20
Email
m.vargas.terrones@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ruben Barakat Carballo, PhD
Phone
+34 91 336 41 20
Email
rubenomar.barakat@upm.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruben Barakat Carballo, PhD
Organizational Affiliation
Universidad Politécnica de Madrid.
Official's Role
Study Director
Facility Information:
Facility Name
Universidad Politécnica de Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marina Vargas Terrones, PhD
Email
m.vargas.terrones@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
http://afipe.es/embarazo-y-ejercicio.html
Description
Research team website
Learn more about this trial
Exercise During Pregnancy and Urinary Incontinence
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