Preventing Pelvic Floor Dysfunction With Pelvic Floor Exercises

January 11, 2024 updated by: Gizem Türkmen, Bandırma Onyedi Eylül University

Preventing Pelvic Floor Dysfunction With Standard and Reflexive Pelvic Floor Exercises in Addition to Global Postural Re-education

Study participants will be randomised into 2 groups. Group 1: 1st assessment + 6 weeks of Global Postural Reeducation training plus standard pelvic floor exercises + 2nd assessment + 6 weeks of Global Postural Reeducation training plus standard pelvic floor exercises + 3rd assessment 2nd Group: 1st assessment + 6 weeks of Global Postural Reeducation training plus involuntary reflexive pelvic floor exercises + 2nd assessment + 6 weeks of Global Postural Reeducation training plus involuntary reflexive pelvic floor exercises + 3rd assessment

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Voluntary participants who agreed to participate in the study will be randomised into 2 groups of 36 people each (standard pelvic floor exercises and involuntary reflexive pelvic floor exercises) with the "Research Randomizer" programme (https://www.randomizer.org/). Group 1 (36 people) will receive Global Postural Reeducation training plus standard pelvic floor exercises for 12 weeks, 7 days a week (Total 84 sessions, 15 sessions face to face, 69 sessions home programme). Even numbers will be included in the 2nd group (36 people) and involuntary reflexive pelvic floor exercises will be given in addition to Global Postural Reeducation training for 12 weeks, 7 days a week (Total 84 sessions, 15 sessions face-to-face, 69 sessions home programme). In the study, detailed pelvic floor training will be given to both groups and the same assessments will be made on the pelvic floor muscles. After the initial assessments are completed, both groups will be given a total of 42 sessions of standard and involuntary reflexive pelvic floor exercises for 6 weeks (7 days a week). Participants in both groups will be evaluated at the end of 6 weeks and the remaining 6 weeks exercise programme will be given according to the arranged programme. At the end of the 12th week, the participants will be evaluated again.

Group 1: 1st assessment + 6 weeks of Global Postural Reeducation training plus standard pelvic floor exercises + 2nd assessment + 6 weeks of Global Postural Reeducation training plus standard pelvic floor exercises + 3rd assessment 2nd Group: 1st assessment + 6 weeks of Global Postural Reeducation training plus involuntary reflexive pelvic floor exercises + 2nd assessment + 6 weeks of Global Postural Reeducation training plus involuntary reflexive pelvic floor exercises + 3rd assessment

Study Type

Interventional

Enrollment (Estimated)

36

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

  • Turkey
    • Balıkesir
      • Bandırma, Balıkesir, Turkey, 10200
        • Bandırma Onyedi Eylül University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Volunteering to participate in the study
  • Being a desk worker between the ages of 18-65
  • No pelvic floor dysfunction
  • Being a woman

Exclusion Criteria:

  • Systemic diseases such as hypertension and diabetes mellitus
  • Presence of respiratory disease (asthma, COPD, etc...)
  • Hormone replacement therapy
  • History of neurogenic bladder
  • Gynaecological cancer or collagen disease
  • Breastfeeding
  • Pregnancy
  • Early postnatal period (less than one year)
  • Pelvic organ prolapse (POP) or gynecological surgery
  • Menopause
  • Psychiatric comorbidities and/or cognitive impairment
  • Impossibility of intra-vaginal physiotherapeutic examination due to untreated active or recurrent urinary infection, haematuria, or vaginal pain during physiotherapy assessment

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard pelvic floor exercises
Standard pelvic floor exercises in addition to Global Postural Reeducation training
Other: Standard pelvic floor exercises
Pelvic floor muscle exercises will be given as 2 separate exercises including fast and slow contractions. For fast contractions, participants will be asked to contract their pelvic floor muscles strongly, hold them contracted for 5 seconds, and then relax them. For slow contractions, participants will be asked to gradually contract the pelvic floor muscles, hold them at maximum contraction for 5 seconds, and relax them gradually. Participants will be asked to perform 10 slow contractions after every 10 fast contractions. The aim is to train strength, coordination, endurance, and symmetry of pelvic floor muscles, motor learning and control, dynamic lumbopelvic stability, pelvic floor, and abdominal co-contraction. Every day, 10 fast, and 10 slow contractions with a total of 20 repetitions will be applied without changing the number by modifying the exercises every week. It will be applied for a total of 12 weeks.
Experimental: Involuntary reflexive pelvic floor exercises
Involuntary reflexive pelvic floor exercises in addition to Global Postural re-education training
Other: Involuntary reflexive pelvic floor exercises
Reflexive exercises (jump, squat jump, etc.) with 20 repetitions per day will be applied to the participants for 12 weeks with modifications every week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pelvic Floor Distress Inventory-PFDI-20
Time Frame: Baseline
The inventory consists of 3 sub-dimensions and contains 20 questions in total. The number of questions of each sub-dimension is indicated next to the name of that sub-dimension (For example; KRADE-8 contains 8 questions in total. The answer option of each question is divided into two as no and yes. Yes option is graded from Unimportant to Very. No=0, and the level of the answer of Yes corresponds to Insignificant=1, Less=1, Less=2, Moderate=3, Very=4 points. The score calculation system of the inventory is as follows; the average score of each sub-dimension is multiplied by 25. The number of points of 3 sub-dimensions is summed and a number between 0-300 points is obtained. The higher the score, the more serious the individual's problems are.
Baseline
Pelvic Floor Distress Inventory-PFDI-20
Time Frame: 6 Weeks Later
The inventory consists of 3 sub-dimensions and contains 20 questions in total. The number of questions of each sub-dimension is indicated next to the name of that sub-dimension (For example; KRADE-8 contains 8 questions in total. The answer option of each question is divided into two as no and yes. Yes option is graded from Unimportant to Very. No=0, and the level of the answer of Yes corresponds to Insignificant=1, Less=1, Less=2, Moderate=3, Very=4 points. The score calculation system of the inventory is as follows; the average score of each sub-dimension is multiplied by 25. The number of points of 3 sub-dimensions is summed and a number between 0-300 points is obtained. The higher the score, the more serious the individual's problems are.
6 Weeks Later
Pelvic Floor Distress Inventory-PFDI-20
Time Frame: 12 Weeks Later
The inventory consists of 3 sub-dimensions and contains 20 questions in total. The number of questions of each sub-dimension is indicated next to the name of that sub-dimension (For example; KRADE-8 contains 8 questions in total. The answer option of each question is divided into two as no and yes. Yes option is graded from Unimportant to Very. No=0, and the level of the answer of Yes corresponds to Insignificant=1, Less=1, Less=2, Moderate=3, Very=4 points. The score calculation system of the inventory is as follows; the average score of each sub-dimension is multiplied by 25. The number of points of 3 sub-dimensions is summed and a number between 0-300 points is obtained. The higher the score, the more serious the individual's problems are.
12 Weeks Later
The female sexual function index (FSFI)
Time Frame: Baseline
This scale assesses six dimensions of sexual function: sexual desire (first 2 questions), sexual arousal (questions 3-6), lubrication (questions 7-10), orgasm (questions 11-13), satisfaction (questions 14-16) and pain or discomfort (e.g. pain associated with vaginal penetration, questions 17-19). The highest total raw score that can be obtained in this scale is 95.0 and the lowest raw score is 4.0. Factor loadings used for scoring the whole scale were determined as 0.6 for sexual desire, 0.3 for sexual arousal and lubrication, 0.4 for orgasm, satisfaction and pain/discomfort. After multiplication by factor loadings, the highest score is 36.0 and the lowest score is 2.0. Total score >22.7 indicates normal sexual function and ≤ 22.7 indicates sexual dysfunction.
Baseline
The female sexual function index (FSFI)
Time Frame: 6 Weeks Later
This scale assesses six dimensions of sexual function: sexual desire (first 2 questions), sexual arousal (questions 3-6), lubrication (questions 7-10), orgasm (questions 11-13), satisfaction (questions 14-16) and pain or discomfort (e.g. pain associated with vaginal penetration, questions 17-19). The highest total raw score that can be obtained in this scale is 95.0 and the lowest raw score is 4.0. Factor loadings used for scoring the whole scale were determined as 0.6 for sexual desire, 0.3 for sexual arousal and lubrication, 0.4 for orgasm, satisfaction and pain/discomfort. After multiplication by factor loadings, the highest score is 36.0 and the lowest score is 2.0. Total score >22.7 indicates normal sexual function and ≤ 22.7 indicates sexual dysfunction.
6 Weeks Later
The female sexual function index (FSFI)
Time Frame: 12 Weeks Later
This scale assesses six dimensions of sexual function: sexual desire (first 2 questions), sexual arousal (questions 3-6), lubrication (questions 7-10), orgasm (questions 11-13), satisfaction (questions 14-16) and pain or discomfort (e.g. pain associated with vaginal penetration, questions 17-19). The highest total raw score that can be obtained in this scale is 95.0 and the lowest raw score is 4.0. Factor loadings used for scoring the whole scale were determined as 0.6 for sexual desire, 0.3 for sexual arousal and lubrication, 0.4 for orgasm, satisfaction and pain/discomfort. After multiplication by factor loadings, the highest score is 36.0 and the lowest score is 2.0. Total score >22.7 indicates normal sexual function and ≤ 22.7 indicates sexual dysfunction.
12 Weeks Later
Global Pelvic Floor Bother Questionnaire
Time Frame: Baseline
The scale consists of 9 questions in total. The questions were graded as "yes" or "no" (0) according to whether they had the complaint or not, and if they answered yes, how much the complaint bothered them was graded as "not at all" (1), "very little" (2), "a little" (3), "quite" (4), "very much" (5). Each question was given a score between 1 and 5. The scoring system gives the same weight to each question. The total score is between 0 and 45. For a score between 0 and 100, the total score is averaged and multiplied by 20. A high score indicates a high number of complaints.
Baseline
Global Pelvic Floor Bother Questionnaire
Time Frame: 6 Weeks Later
The scale consists of 9 questions in total. The questions were graded as "yes" or "no" (0) according to whether they had the complaint or not, and if they answered yes, how much the complaint bothered them was graded as "not at all" (1), "very little" (2), "a little" (3), "quite" (4), "very much" (5). Each question was given a score between 1 and 5. The scoring system gives the same weight to each question. The total score is between 0 and 45. For a score between 0 and 100, the total score is averaged and multiplied by 20. A high score indicates a high number of complaints.
6 Weeks Later
Global Pelvic Floor Bother Questionnaire
Time Frame: 12 Weeks Later
The scale consists of 9 questions in total. The questions were graded as "yes" or "no" (0) according to whether they had the complaint or not, and if they answered yes, how much the complaint bothered them was graded as "not at all" (1), "very little" (2), "a little" (3), "quite" (4), "very much" (5). Each question was given a score between 1 and 5. The scoring system gives the same weight to each question. The total score is between 0 and 45. For a score between 0 and 100, the total score is averaged and multiplied by 20. A high score indicates a high number of complaints.
12 Weeks Later
Overactive Bladder Questionnaire (OAB-V8)
Time Frame: Baseline
The OAB-V8 consists of the first 8 questions of the OAB-q and has been proposed as an overactive bladder screening and awareness test.
Baseline
Overactive Bladder Questionnaire (OAB-V8)
Time Frame: 6 Weeks Later
The OAB-V8 consists of the first 8 questions of the OAB-q and has been proposed as an overactive bladder screening and awareness test.
6 Weeks Later
Overactive Bladder Questionnaire (OAB-V8)
Time Frame: 12 Weeks Later
The OAB-V8 consists of the first 8 questions of the OAB-q and has been proposed as an overactive bladder screening and awareness test.
12 Weeks Later
Pelvic Muscle Assessment
Time Frame: Baseline
The PERFECT Scale can be used to assess voluntary contraction strength (P), endurance (E), slow-twitch muscle fibre performance (R), fast-twitch muscle fibre performance (F), pelvic floor muscle contraction pattern (E), transversus abdominus muscle cocontraction (C) and involuntary contraction in response to increased intra-abdominal pressure (T).
Baseline
Pelvic Muscle Assessment
Time Frame: 6 Weeks Later
The PERFECT Scale can be used to assess voluntary contraction strength (P), endurance (E), slow-twitch muscle fibre performance (R), fast-twitch muscle fibre performance (F), pelvic floor muscle contraction pattern (E), transversus abdominus muscle cocontraction (C) and involuntary contraction in response to increased intra-abdominal pressure (T).
6 Weeks Later
Pelvic Muscle Assessment
Time Frame: 12 Weeks Later
The PERFECT Scale can be used to assess voluntary contraction strength (P), endurance (E), slow-twitch muscle fibre performance (R), fast-twitch muscle fibre performance (F), pelvic floor muscle contraction pattern (E), transversus abdominus muscle cocontraction (C) and involuntary contraction in response to increased intra-abdominal pressure (T).
12 Weeks Later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Waist/ Hip Ratio
Time Frame: Baseline
Waist-to-hip ratio (WHR) is the waist circumference divided by the hip circumference
Baseline
Waist/ Hip Ratio
Time Frame: 6 Weeks Later
Waist-to-hip ratio (WHR) is the waist circumference divided by the hip circumference
6 Weeks Later
Waist/ Hip Ratio
Time Frame: 12 Weeks Later
Waist-to-hip ratio (WHR) is the waist circumference divided by the hip circumference
12 Weeks Later
Estimating body fat
Time Frame: Baseline
This technique is based on the compression of the skin fold to measure the skin and the subcutaneous fat layer beneath it. To improve accuracy, multiple readings are taken in each body region and these readings are averaged and evaluated. The most common application is to measure skinfold thickness from three or four areas of the body and estimate the percentage of BF using prognostic equations.
Baseline
Estimating body fat
Time Frame: 6 Weeks Later
This technique is based on the compression of the skin fold to measure the skin and the subcutaneous fat layer beneath it. To improve accuracy, multiple readings are taken in each body region and these readings are averaged and evaluated. The most common application is to measure skinfold thickness from three or four areas of the body and estimate the percentage of BF using prognostic equations.
6 Weeks Later
Estimating body fat
Time Frame: 12 Weeks Later
This technique is based on the compression of the skin fold to measure the skin and the subcutaneous fat layer beneath it. To improve accuracy, multiple readings are taken in each body region and these readings are averaged and evaluated. The most common application is to measure skinfold thickness from three or four areas of the body and estimate the percentage of BF using prognostic equations.
12 Weeks Later
ICIQ-SF: International Consultation on Incontinence Questionnaire-Short Form
Time Frame: Baseline
The International Consultation on Incontinence Questionaire Short Form (ICIQ-SF), which has Turkish validity and reliability, will be used to question the type, frequency, amount and effects of urinary incontinence on daily life.
Baseline
ICIQ-SF: International Consultation on Incontinence Questionnaire-Short Form
Time Frame: 6 Weeks Later
The International Consultation on Incontinence Questionaire Short Form (ICIQ-SF), which has Turkish validity and reliability, will be used to question the type, frequency, amount and effects of urinary incontinence on daily life.
6 Weeks Later
ICIQ-SF: International Consultation on Incontinence Questionnaire-Short Form
Time Frame: 12 Weeks Later
The International Consultation on Incontinence Questionaire Short Form (ICIQ-SF), which has Turkish validity and reliability, will be used to question the type, frequency, amount and effects of urinary incontinence on daily life.
12 Weeks Later

Collaborators and Investigators

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

Sponsor

Bandırma Onyedi Eylül University

Collaborators

Ebru Kaya Mutlu

Investigators

  • Study Director: Ebru Kaya Mutlu, Professor, PhD, Bandırma Onyedi Eylül University

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)

December 1, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

December 19, 2023

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023-30

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.

Clinical Trials on Prevention Pelvic Muscle Dysfunction

Clinical Trials on Standard pelvic floor exercises

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe