Back to resultsHypopressive Effectiveness in Postural Control and Pelvic Floor.
Primary Purpose
Pelvic Floor Disorders, Postural; Defect, Muscle Weakness
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Hypopressive exercises
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Floor Disorders
Eligibility Criteria
Inclusion Criteria:
- Women
- Physical autonomy
Exclusion Criteria:
- Vestibular disorders.
- Coronary diseases.
- Recent surgery.
Sites / Locations
- University of Jaen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Hypopressive exercises
Control group
Arm Description
Patients completed 10 weeks of abdominal hypopressive exercises with two sessions of 30 minutes per week.
Patients allocated to the control group did not receive any treatment.
Outcomes
Primary Outcome Measures
Postural control
Postural control was evaluated by means of a stabilometric platform of resistive pressure sensors (Sensor Medica, Rome, Italy).
Secondary Outcome Measures
Pelvic floor muscles strength
The assessment of the overall contractility of the striated pelvic floor musculature was evaluated according to the modified manual scale Oxford.
Self-reported pelvic floor status
To assess self-reported status the Pelvic Floor Distress Inventory-Short Form was administered.
Urinary incontinence
To determine the presence and improvement in urinary incontinence the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form was employed.
Transversus abdominis activation
Transversus abdominis thickness during contraction was assessed by real time ultrasound imaging.
Pulmonary ventilation
A forced spirometry test was employed to assess pulmonary function.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04343599
Brief Title
Hypopressive Effectiveness in Postural Control and Pelvic Floor.
Official Title
Hypopressive Effectiveness in Postural Control and Pelvic Floor.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
June 7, 2019 (Actual)
Study Completion Date
June 12, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jaén
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Effects of an exercise program based on hypopressive exercises in the female population.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders, Postural; Defect, Muscle Weakness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study was a single-blinded randomized controlled trial
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
An independent assessor blinded to the data collection was responsible for the allocation process. A list of the computer-generated number was employed to assign participants to experimental or control group
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypopressive exercises
Arm Type
Experimental
Arm Description
Patients completed 10 weeks of abdominal hypopressive exercises with two sessions of 30 minutes per week.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients allocated to the control group did not receive any treatment.
Intervention Type
Other
Intervention Name(s)
Hypopressive exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postural control
Description
Postural control was evaluated by means of a stabilometric platform of resistive pressure sensors (Sensor Medica, Rome, Italy).
Time Frame
From baseline to 10 weeks.
Secondary Outcome Measure Information:
Title
Pelvic floor muscles strength
Description
The assessment of the overall contractility of the striated pelvic floor musculature was evaluated according to the modified manual scale Oxford.
Time Frame
From baseline to 10 weeks.
Title
Self-reported pelvic floor status
Description
To assess self-reported status the Pelvic Floor Distress Inventory-Short Form was administered.
Time Frame
From baseline to 10 weeks
Title
Urinary incontinence
Description
To determine the presence and improvement in urinary incontinence the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form was employed.
Time Frame
From baseline to 10 weeks
Title
Transversus abdominis activation
Description
Transversus abdominis thickness during contraction was assessed by real time ultrasound imaging.
Time Frame
From baseline to 10 weeks.
Title
Pulmonary ventilation
Description
A forced spirometry test was employed to assess pulmonary function.
Time Frame
From baseline to 10 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women
Physical autonomy
Exclusion Criteria:
Vestibular disorders.
Coronary diseases.
Recent surgery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Cruz-Díaz
Organizational Affiliation
University of Jaén
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Jaen
City
Jaén
ZIP/Postal Code
23071
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Provided by reasonable request.
Learn more about this trial
Hypopressive Effectiveness in Postural Control and Pelvic Floor.
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