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Effectiveness of Hipopressive Exercises Versus Classical Perineal Physiotherapy (HEPFD)

Primary Purpose

Pelvic Floor Disorders, Urinary Incontinence, Fecal Incontinence

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Hipopressive exercises
Therapeutic education.
Pelviperineal physiotherapy
Physical Therapy assessment
Sponsored by
University of Alcala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Floor Disorders focused on measuring Women, Pelvic floor disorders, Urinary incontinence, Fecal incontinence, Physical Therapy Modalities

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women who experience signs and symptoms evidencing pelvic floor dysfunction.
  • Women with a medical diagnosis of pelvic floor dysfunction.
  • Women with signs and or symptoms of urinary incontinence, anal incontinence, overactive bladder syndrome and prolapse in grade I-II.
  • All participants must understand and sign freely Informed Consent.

Exclusion Criteria:

  • Women minors.
  • Pregnant women.
  • Women who have had a vaginal delivery or cesarean in the past six months.
  • Women with pelvic floor dysfunction which is serious and the first indication is surgical (prolapses grades III-IV).
  • Women who have been treated for perineal physiotherapy in the past 12 months.
  • Participants submit any pathology that may affect treatment (neurological, gynecological or urological), or recurrent urinary tract infection or hematuria.
  • Women with cognitive limitations in understanding the information, respond to questionnaires, consent and / or participate in the study.

Sites / Locations

  • Teacher care and research in physiotherapy Unit. Department of Physiotherapy. University of Alcala.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Pelviperineal physiotherapy

Hiporessive and Pelviperineal PT

Hipopressive exercises

Arm Description

The treatment duration is 2 days per week during 8 weks (two months). The aproximate duration of the season is 45 minutes. The protocol consists in: Anatomical and physiological explanation of the pelvic girdle (perineal organs bony, ligaments and muscular structures of the entire abdominal and pelvic cavity). Hygienic and behavioral advises preventing pelvic floor dysfunctions. Awareness of the pelvic floor muscles. Strengthening the pelvic floor muscles and the entire abdominal pelvic cavity. Use of electrostimulation and biofeedback in different positions if deemed necessary. Treatment the abdominal-pelvic cavity pain if it requires.

The treatment duration is 2 days per week, 8 weeks (two months). The session is about 45 minutes. All women are instructed on hygienic and behavioral advises preventing pelvic floor dysfunctions. They are teach basic anatomy and physiology to understand the importance of these advises and anatomical and physiological explanation of the pelvic girdle. The participants are also treated by doing Hipopressive exercises and by specific physicaltherapy for the strengthening the pelvic floor muscles.

The treatment is done 2 times per week for 8 weeks (2 months). The session duration is about 45 minutes. All participants are instructed on hygienic and behavioral advises preventing pelvic floor dysfunctions. They are teach basic anatomy and physiology to understand the importance of these advises and anatomical and physiological explanation of the pelvic girdle (perineal organs bony, ligaments and muscular structures of the entire abdominal and pelvic cavity). The participants are also treated by doing Hipopressive exercises in standing, sitting, and supine fours.

Outcomes

Primary Outcome Measures

The change of signs, symptoms and impact of pelvic floor dysfunction between reviews
- Improve the impact of pelvic floor dysfunctions by 30% according to Spanish short version of Pelvic Floor Impact Questionnaire (PFIQ-7).
The change of signs, symptoms and impact of pelvic floor dysfunction between reviews
- Improve the signs and symptoms of pelvic floor dysfunction by 30% according to Spanish short version of Pelvic Floor Distress Inventory (PFDI-20).

Secondary Outcome Measures

The change of pelvic floor muscles strenght
- Improve the strength of the pelvic floor muscles by 2 points according to the Modified Oxford Scale.
The change of pelvic floor muscles pressure force
- Improve the strength of pelvic floor in 10 cm H2O measured with digital perineometer.

Full Information

First Posted
September 5, 2014
Last Updated
October 7, 2014
Sponsor
University of Alcala
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1. Study Identification

Unique Protocol Identification Number
NCT02259712
Brief Title
Effectiveness of Hipopressive Exercises Versus Classical Perineal Physiotherapy
Acronym
HEPFD
Official Title
Randomized Clinical Trial on the Effectiveness of Hipopressive Exercises Versus Classical Perineal Physiotherapy in Women With Pelvic Floor Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
November 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Introduction: Hipopressive Exercises are included within a method of physiotherapy which was created with the purpose of strengthening the deep muscles of the abdomen without damaging ligamentous and muscular structures of the perineum, also strengthening the muscles of pelvic floor reflexively. Although this technique has been included as treatment and a prevention method of pelvic floor dysfunction, there are few studies supporting its benefits. The investigators hypotthesis is that the combination of both physical therapy treatments will provided the best results for women who suffer pelvic floor dysfunctions. Objective: To determine whether Hipopressive Exercises are an option to include in the physiotherapy treatment of women suffer at least one pelvic floor dysfunction and whether the results reported are comparable to those provided by the classical perineal physiotherapy. Subjects and methods: A randomized clinical trial, the examiner being blinded unaware of the intervention group to which subjects were assigned. Participants will be randomly assigned to three groups: An experimental group, where the participants will be treated by Hipopressive exercises and hygienic and behavioral measures; Another experimental group where classical perineal physiotherapy will join with Hipopressive exercises and hygienic and behavioral advises; And a third group where will be done classical perineal physiotherapy and hygienic and behavioral measures. Pre- intervention, immediate post-intervention, 3, 6 and 12 months assessments will be made. The selection criteria will be: adult women who present signs and symptoms that indicate a pelvic floor dysfunction or have a medical diagnosis to confirm it. All participants must understand and sign freely Informed Consent. Sample size: Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 26 subjects were required in each group to detect a difference equal to or greater than 3 microvolts (Total of 78 subjects). It assumes a standard deviation of 4.8 microvolts and the rate of loss to follow up esteem 20% (Magalhães-Resende et al. 2012). Data Analysis: A descriptive analysis of all variables was performed. It establish for all cases a confidence level of 95% (p <0.05). The effectiveness was assessed by comparing the experienced change of the three goups in outcome variables between physicaltherapy examinations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders, Urinary Incontinence, Fecal Incontinence, Pelvic Pain
Keywords
Women, Pelvic floor disorders, Urinary incontinence, Fecal incontinence, Physical Therapy Modalities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pelviperineal physiotherapy
Arm Type
Active Comparator
Arm Description
The treatment duration is 2 days per week during 8 weks (two months). The aproximate duration of the season is 45 minutes. The protocol consists in: Anatomical and physiological explanation of the pelvic girdle (perineal organs bony, ligaments and muscular structures of the entire abdominal and pelvic cavity). Hygienic and behavioral advises preventing pelvic floor dysfunctions. Awareness of the pelvic floor muscles. Strengthening the pelvic floor muscles and the entire abdominal pelvic cavity. Use of electrostimulation and biofeedback in different positions if deemed necessary. Treatment the abdominal-pelvic cavity pain if it requires.
Arm Title
Hiporessive and Pelviperineal PT
Arm Type
Experimental
Arm Description
The treatment duration is 2 days per week, 8 weeks (two months). The session is about 45 minutes. All women are instructed on hygienic and behavioral advises preventing pelvic floor dysfunctions. They are teach basic anatomy and physiology to understand the importance of these advises and anatomical and physiological explanation of the pelvic girdle. The participants are also treated by doing Hipopressive exercises and by specific physicaltherapy for the strengthening the pelvic floor muscles.
Arm Title
Hipopressive exercises
Arm Type
Experimental
Arm Description
The treatment is done 2 times per week for 8 weeks (2 months). The session duration is about 45 minutes. All participants are instructed on hygienic and behavioral advises preventing pelvic floor dysfunctions. They are teach basic anatomy and physiology to understand the importance of these advises and anatomical and physiological explanation of the pelvic girdle (perineal organs bony, ligaments and muscular structures of the entire abdominal and pelvic cavity). The participants are also treated by doing Hipopressive exercises in standing, sitting, and supine fours.
Intervention Type
Other
Intervention Name(s)
Hipopressive exercises
Other Intervention Name(s)
Hipopressive kinesiotherapy
Intervention Description
45 minutes treatment by hipopressive exercises 2 times per week during 8 weeks. They will be doing in different positions: standing, kneeling, sitting and lying. The patient will be teach a total of 30 exercises. In the week number 8 the women with the physical therapist will choose 3 exercises that will be done daily at home during 20 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic education.
Other Intervention Name(s)
Hygienic and behavioral advises.
Intervention Description
The therapeutic education will be doing during the 8 weeks of treatment. In the first day the knowledge and the briefs of the pelvic floor dysfunction will be assessed. Dietary and behavioral habits will also be discussed. In the second day anatomical and physiological explanation of the pelvic girdle will be the priority. In the third day will be explained the signs and symptoms of the different pelvic floor dysfunctions. In the four day will be analyzed the risk factors that may cause or worsen pelvic floor dysfunctions. In the fifth day will be begun to correct the bad habits. In the last day will be reviewed the knowledge and new habits acquired during the treatment. In all treatment days will be discussed the doubts of the participant.
Intervention Type
Other
Intervention Name(s)
Pelviperineal physiotherapy
Other Intervention Name(s)
Specific physical therapy.
Intervention Description
45 minutes physical therapy treatment 2 times per week during 8 weeks. There will be done specific exercises of the pelvic floor muscles and coordination exercises of the pelvic floor muscles with other muscles in different positions. Electrostimulation, biofeedbak, cones and dinamometric devices can be employed to improve the muscle performance.
Intervention Type
Other
Intervention Name(s)
Physical Therapy assessment
Other Intervention Name(s)
Physiotherapy evaluation
Intervention Description
Pre-treatment, post-treatment, 3, 6 and 12 months after physical therapy treatment. Will be done a specific evaluation of pelvic floor muscles using the Modified Oxford Scale, superficial electromyography, perineometry and dynamometer. For the evaluation of the impact, the signs and the symptoms questionnaires will be completed by the participants.
Primary Outcome Measure Information:
Title
The change of signs, symptoms and impact of pelvic floor dysfunction between reviews
Description
- Improve the impact of pelvic floor dysfunctions by 30% according to Spanish short version of Pelvic Floor Impact Questionnaire (PFIQ-7).
Time Frame
Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.
Title
The change of signs, symptoms and impact of pelvic floor dysfunction between reviews
Description
- Improve the signs and symptoms of pelvic floor dysfunction by 30% according to Spanish short version of Pelvic Floor Distress Inventory (PFDI-20).
Time Frame
Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.
Secondary Outcome Measure Information:
Title
The change of pelvic floor muscles strenght
Description
- Improve the strength of the pelvic floor muscles by 2 points according to the Modified Oxford Scale.
Time Frame
Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.
Title
The change of pelvic floor muscles pressure force
Description
- Improve the strength of pelvic floor in 10 cm H2O measured with digital perineometer.
Time Frame
Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women who experience signs and symptoms evidencing pelvic floor dysfunction. Women with a medical diagnosis of pelvic floor dysfunction. Women with signs and or symptoms of urinary incontinence, anal incontinence, overactive bladder syndrome and prolapse in grade I-II. All participants must understand and sign freely Informed Consent. Exclusion Criteria: Women minors. Pregnant women. Women who have had a vaginal delivery or cesarean in the past six months. Women with pelvic floor dysfunction which is serious and the first indication is surgical (prolapses grades III-IV). Women who have been treated for perineal physiotherapy in the past 12 months. Participants submit any pathology that may affect treatment (neurological, gynecological or urological), or recurrent urinary tract infection or hematuria. Women with cognitive limitations in understanding the information, respond to questionnaires, consent and / or participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beatriz N Navarro, PhD student
Phone
+34918854828
Email
b.navarrobrazalez@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
María T Torres, PhD
Phone
+34918854828
Email
maria.torres@uah.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatriz N Navarro, PhD student
Organizational Affiliation
University of Alcala
Official's Role
Principal Investigator
Facility Information:
Facility Name
Teacher care and research in physiotherapy Unit. Department of Physiotherapy. University of Alcala.
City
Alcalá de Henares
State/Province
Madrid
ZIP/Postal Code
28871
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beatriz N Navarro, PhD student
Phone
+34-91-885-48-28
Email
b.navarrobrazalez@gmail.com
First Name & Middle Initial & Last Name & Degree
María T Torres, PhD
Phone
+34-91-885-48-28
Email
maria.torres@uah.es
First Name & Middle Initial & Last Name & Degree
Beatriz N Navarro, PhD student

12. IPD Sharing Statement

Links:
URL
http://www2.uah.es/fisioterapia_saludmujer/
Description
Research Group Info

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Effectiveness of Hipopressive Exercises Versus Classical Perineal Physiotherapy

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