- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03997045
Exercise During Pregnancy and Urinary Incontinence
June 24, 2019 updated by: Marina Vargas Terrones, Universidad Politecnica de Madrid
Effect of Physical Exercise Program During Pregnancy on Urinary Incontinence
The aim of this study is to examine the effect of a supervised physical exercise program during pregnancy on urinary incontinence.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marina Vargas Terrones, PhD
- Phone Number: +34 91 336 41 20
- Email: m.vargas.terrones@gmail.com
Study Contact Backup
- Name: Ruben Barakat Carballo, PhD
- Phone Number: +34 91 336 41 20
- Email: rubenomar.barakat@upm.es
Study Locations
-
-
-
Madrid, Spain, 28040
- Recruiting
- Universidad Politecnica de Madrid
-
Contact:
- Marina Vargas Terrones, PhD
- Email: m.vargas.terrones@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Healthy pregnant women
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
Pregnant women receiving usual care and participating in supervised physical exercise program.
|
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.
|
No Intervention: Control group
Pregnant women that are receiving usual care but are not participating in supervised physical exercise program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urinary incontinence
Time Frame: Gestational week 36-38
|
Urinary incontinence was measured by the International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF).
|
Gestational week 36-38
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Rubén Barakat Carballo, PhD, Universidad Politécnica de Madrid.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2019
Primary Completion (Anticipated)
January 31, 2020
Study Completion (Anticipated)
July 30, 2020
Study Registration Dates
First Submitted
June 24, 2019
First Submitted That Met QC Criteria
June 24, 2019
First Posted (Actual)
June 25, 2019
Study Record Updates
Last Update Posted (Actual)
June 25, 2019
Last Update Submitted That Met QC Criteria
June 24, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AFIPE-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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