Effects of the Hypopressive Exercises in Women With Pelvic Organ Prolapse

NCT ID: NCT06352112

Last Updated: 2024-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-15

Study Completion Date

2024-02-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pelvic Floor Disorders Prolapse; Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Pelvic Floor Muscle Training

Participants received pelvic floor muscle training only.

Group Type EXPERIMENTAL

Pelvic Floor Muscle Training

Intervention Type OTHER

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.

Pelvic Floor Muscle Training combined with Hypopressive Exercises

Participants received hypopressive exercise in addition to pelvic floor muscle training.

Group Type EXPERIMENTAL

Pelvic Floor Muscle Training

Intervention Type OTHER

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.

Hypopressive Exercises

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Hypopressive 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Training and Research Hospital

OTHER_GOV

Sponsor Role collaborator

Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Turkan Akbayrak

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Türkan Akbayrak, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

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Istanbul Research and Training Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 22038880 (View on PubMed)

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.

Reference Type RESULT
PMID: 22344353 (View on PubMed)

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.

Reference Type RESULT
PMID: 30311680 (View on PubMed)

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.

Reference Type RESULT
PMID: 36418569 (View on PubMed)

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.

Reference Type RESULT
PMID: 36482844 (View on PubMed)

Other Identifiers

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02.04.2024 - POP

Identifier Type: -

Identifier Source: org_study_id

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