Exercise During Pregnancy and Urinary Incontinence

Sponsor

Universidad Politecnica de Madrid (Other)

Overall Status

Unknown status

CT.gov ID

NCT03997045

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Healthy	Behavioral: Supervised physical exercise program	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Prevention

Official Title:

Effect of Physical Exercise Program During Pregnancy on Urinary Incontinence

Actual Study Start Date :

Mar 1, 2019

Anticipated Primary Completion Date :

Jan 31, 2020

Anticipated Study Completion Date :

Jul 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group Pregnant women receiving usual care and participating in supervised physical exercise program.	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: Intervention group

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

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

Urinary incontinence [Gestational week 36-38]
Urinary incontinence was measured by the International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy pregnant women

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidad Politécnica de Madrid	Madrid		Spain	28040

Sponsors and Collaborators

Universidad Politecnica de Madrid

Investigators

Study Director: Ruben Barakat Carballo, PhD, Universidad Politécnica de Madrid

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Research team website

Publications

None provided.

Responsible Party:

Marina Vargas Terrones, PhD, Universidad Politecnica de Madrid

ClinicalTrials.gov Identifier:

NCT03997045

Other Study ID Numbers:

AFIPE-001

First Posted:

Jun 25, 2019

Last Update Posted:

Jun 25, 2019

Last Verified:

Jun 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Marina Vargas Terrones, PhD, Universidad Politecnica de Madrid

Pregnancy

Physical exercise

Urinary incontinence

Additional relevant MeSH terms:

Urinary Incontinence

Enuresis

Study Results

No Results Posted as of Jun 25, 2019