- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06352112
Effects of the Hypopressive Exercises in Women With Pelvic Organ Prolapse
April 8, 2024 updated by: Turkan Akbayrak, Hacettepe University
Short-term Effects of the Home-Based Hypopressive Exercises in Women With Pelvic Organ Prolapse: A Retrospective Comparative Study
The aim of this study was compare home-based pelvic floor muscle training (PFMT) alone and home-based PFMT combined with hypopressive exercise (HE) in terms of pelvic floor muscle (PFM) activation and severity of pelvic floor dysfunction (PFD) in women with pelvic organ prolapse (POP) for eight weeks.
For this purpose, the participants were randomly divided into two groups: [PFMT alone (n:15) and PFMT combined with HE(n:17)].
DuoBravo EMG device for evaluation of PFM activation and "Pelvic Floor Distress Inventory-20" was used to evaluate the severity of PFD.
All evaluations were performed twice in total, at baseline and at week 8.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Pelvic floor muscle training (PFMT), which provides increased structural support of the pelvic organs by improving the functional strength, endurance and coordination of the pelvic floor muscles (PFM), has been a grade A recommendation based on Level 1 evidence to improve symptoms and stages of pelvic organ prolapse (POP).
On the other hand, hypopressive exercises (HE) are a group of exercises that, when applied, relax the diaphragm, activate the abdominal muscles, activate the transversus abdominis muscle by reducing intra-abdominal pressure, thus providing reflex activation in the PFM, and are known to improve urinary incontinence and POP with these features.
Although there are studies investigating the effects of both exercise groups on POP, the results of the studies are contradictory and more research is needed on this subject.For this reason, in this study, the investigators aimed to compare home-based PFMT alone and home-based PFMT combined with HE in terms of PFM activation and severity of pelvic floor dysfunction in women with POP for eight weeks.
Study Type
Interventional
Enrollment (Actual)
32
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
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Istanbul, Turkey
- Istanbul Research and Training Hospital
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-
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
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- having been diagnosed with POP according to Pelvic Organ Prolapse Quantification System by a gynecologist;
- being literate
- being between 20-50 years
Exclusion Criteria:
- pregnancy;
- having a cooperation problems;
- history of active cancer;
- finding an urinary infection during evaluation;
- being in the menstrual period during the evaluation;
- neurological, orthopedic or serious medical conditions that may affect the patient's pelvic floor functions.
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: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pelvic Floor Muscle Training
Participants received pelvic floor muscle training only.
|
PFMT consisted of both slow voluntary contractions lasting 15 seconds each (5-s contraction, 5-s hold and 5-s relaxation) and fast voluntary contractions lasting 2-s each.
A set of exercises included 10 slow and 10 fast voluntary contractions.
During the first week, women performed five sets of exercises a day, and the exercises were continued for eight weeks by increasing five sets each week.
The exercises were performed as home exercises.
|
|
Experimental: Pelvic Floor Muscle Training combined with Hypopressive Exercises
Participants received hypopressive exercise in addition to pelvic floor muscle training.
|
PFMT consisted of both slow voluntary contractions lasting 15 seconds each (5-s contraction, 5-s hold and 5-s relaxation) and fast voluntary contractions lasting 2-s each.
A set of exercises included 10 slow and 10 fast voluntary contractions.
During the first week, women performed five sets of exercises a day, and the exercises were continued for eight weeks by increasing five sets each week.
The exercises were performed as home exercises.
HE program in which different placements of the upper and lower extremities were used in standing, sitting and supine positions, and the participants were asked to perform the exercises with a "hypopressive maneuver" to maintain apnea and rib cage expansion for approximately 10 seconds.
Exercises were started with three repetitions a day, and then the number of repetitions was increased to five and/or 10, depending on the participant's tolerance.
The exercises were performed as home exercises.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pelvic Floor Muscle Activation
Time Frame: at baseline and at week 8
|
It was performed with the DuoBravo EMG device.
Patients were asked to squeeze the PFM strongly for 5-s and at the end of the contraction, to relax completely by not pushing the perineum downwards for 5-s.
This cycle was repeated five times in total, and the muscle activation responses at the end of the measurement were recorded in µV.
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at baseline and at week 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Severity of pelvic floor dysfunction
Time Frame: at baseline and at week 8
|
It was performed with the "Pelvic Floor Distress inventory-20 (PFDI-20).
The total score of the scale is between 0-300 and the higher the score obtained as a result of the survey, the greater the severity of pelvic floor dysfunction
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at baseline and at week 8
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Türkan Akbayrak, Prof. Dr., Hacettepe University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Resende AP, Stupp L, Bernardes BT, Oliveira E, Castro RA, Girao MJ, Sartori MG. Can hypopressive exercises provide additional benefits to pelvic floor muscle training in women with pelvic organ prolapse? Neurourol Urodyn. 2012 Jan;31(1):121-5. doi: 10.1002/nau.21149. Epub 2011 Oct 28.
- Bernardes BT, Resende AP, Stupp L, Oliveira E, Castro RA, Bella ZI, Girao MJ, Sartori MG. Efficacy of pelvic floor muscle training and hypopressive exercises for treating pelvic organ prolapse in women: randomized controlled trial. Sao Paulo Med J. 2012;130(1):5-9. doi: 10.1590/s1516-31802012000100002.
- Resende APM, Bernardes BT, Stupp L, Oliveira E, Castro RA, Girao MJBC, Sartori MGF. Pelvic floor muscle training is better than hypopressive exercises in pelvic organ prolapse treatment: An assessor-blinded randomized controlled trial. Neurourol Urodyn. 2019 Jan;38(1):171-179. doi: 10.1002/nau.23819. Epub 2018 Oct 12.
- Bo K, Angles-Acedo S, Batra A, Braekken IH, Chan YL, Jorge CH, Kruger J, Yadav M, Dumoulin C. Are hypopressive and other exercise programs effective for the treatment of pelvic organ prolapse? Int Urogynecol J. 2023 Jan;34(1):43-52. doi: 10.1007/s00192-022-05407-y. Epub 2022 Nov 23.
- Molina-Torres G, Moreno-Munoz M, Rebullido TR, Castellote-Caballero Y, Bergamin M, Gobbo S, Hita-Contreras F, Cruz-Diaz D. The effects of an 8-week hypopressive exercise training program on urinary incontinence and pelvic floor muscle activation: A randomized controlled trial. Neurourol Urodyn. 2023 Feb;42(2):500-509. doi: 10.1002/nau.25110. Epub 2022 Dec 8.
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 15, 2023
Primary Completion (Actual)
January 15, 2024
Study Completion (Actual)
February 15, 2024
Study Registration Dates
First Submitted
April 2, 2024
First Submitted That Met QC Criteria
April 2, 2024
First Posted (Actual)
April 8, 2024
Study Record Updates
Last Update Posted (Actual)
April 10, 2024
Last Update Submitted That Met QC Criteria
April 8, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02.04.2024 - POP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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