Hypopressive Effectiveness in Postural Control and Pelvic Floor.

April 9, 2020 updated by: DAVID CRUZ DÍAZ, University of Jaén
Effects of an exercise program based on hypopressive exercises in the female population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants allocated to the intervention group completed 10 weeks of hypopressive exercises training with a frequency of two sessions of 30 minutes twice a week.

Study Type

Interventional

Enrollment (Actual)

130

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 Locations

  • Spain
      • Jaén, Spain, 23071
        • University of Jaén

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women
  • Physical autonomy

Exclusion Criteria:

  • Vestibular disorders.
  • Coronary diseases.
  • Recent surgery.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypopressive exercises
Patients completed 10 weeks of abdominal hypopressive exercises with two sessions of 30 minutes per week.
Other: Hypopressive exercises
The first two sessions will have as objective the correct and effective learning of the hypopressive technique. The rest of the sessions will be dedicated to the realization of an exercise protocol based on a progression of postures from standing to supine. Diaphragmatic apneas of approximately 7 seconds will be performed, alternating each apnea with three breaths.
No Intervention: Control group
Patients allocated to the control group did not receive any treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postural control
Time Frame: From baseline to 10 weeks.
Postural control was evaluated by means of a stabilometric platform of resistive pressure sensors (Sensor Medica, Rome, Italy).
From baseline to 10 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pelvic floor muscles strength
Time Frame: From baseline to 10 weeks.
The assessment of the overall contractility of the striated pelvic floor musculature was evaluated according to the modified manual scale Oxford.
From baseline to 10 weeks.
Self-reported pelvic floor status
Time Frame: From baseline to 10 weeks
To assess self-reported status the Pelvic Floor Distress Inventory-Short Form was administered.
From baseline to 10 weeks
Urinary incontinence
Time Frame: From baseline to 10 weeks
To determine the presence and improvement in urinary incontinence the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form was employed.
From baseline to 10 weeks
Transversus abdominis activation
Time Frame: From baseline to 10 weeks.
Transversus abdominis thickness during contraction was assessed by real time ultrasound imaging.
From baseline to 10 weeks.
Pulmonary ventilation
Time Frame: From baseline to 10 weeks
A forced spirometry test was employed to assess pulmonary function.
From baseline to 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jaén

Investigators

  • Principal Investigator: David Cruz-Díaz, University of Jaén

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 (Actual)

June 7, 2019

Study Completion (Actual)

June 12, 2019

Study Registration Dates

First Submitted

April 9, 2020

First Submitted That Met QC Criteria

April 9, 2020

First Posted (Actual)

April 13, 2020

Study Record Updates

Last Update Posted (Actual)

April 13, 2020

Last Update Submitted That Met QC Criteria

April 9, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hypouja

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Provided by reasonable request.

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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