NCT03997045

Brief Summary

The aim of this study is to examine the effect of a supervised physical exercise program during pregnancy on urinary incontinence.

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
50

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
Completed

Started Mar 2019

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

March 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

11 months

First QC Date

June 24, 2019

Last Update Submit

June 24, 2019

Conditions

PregnancyHealthy

Keywords

PregnancyPhysical exerciseUrinary incontinence

Outcome Measures

Primary Outcomes (1)

  • Urinary incontinence

    Urinary incontinence was measured by the International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF).

    Gestational week 36-38

Study Arms (2)

Intervention group

EXPERIMENTAL

Pregnant women receiving usual care and participating in supervised physical exercise program.

Behavioral: Supervised physical exercise program

Control group

NO INTERVENTION

Pregnant women that are receiving usual care but are not participating in supervised physical exercise program.

Interventions

Supervised physical exercise programBEHAVIORAL

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.

Intervention group

Eligibility Criteria

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

You may qualify if:

  • Healthy pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Politécnica de Madrid

Madrid, 28040, Spain

RECRUITING

Related Links

MeSH Terms

Conditions

Motor ActivityUrinary Incontinence

Condition Hierarchy (Ancestors)

BehaviorUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ruben Barakat Carballo, PhD

    Universidad Politecnica de Madrid

    STUDY DIRECTOR

Central Study Contacts

Marina Vargas Terrones, PhD

CONTACT

+34 91 336 41 20m.vargas.terrones@gmail.com

Ruben Barakat Carballo, PhD

CONTACT

+34 91 336 41 20rubenomar.barakat@upm.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 24, 2019

First Posted

June 25, 2019

Study Start

March 1, 2019

Primary Completion

January 31, 2020

Study Completion

July 30, 2020

Last Updated

June 25, 2019

Record last verified: 2019-06

Locations

ES(1)