Investigation of the Effect of Manual Therapy and Pelvic Floor Exercises on Pelvic Floor Muscles

NCT ID: NCT06494917

Last Updated: 2024-07-15

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

RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-14

Study Completion Date

2024-09-30

Brief Summary

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The goal of this clinical trial is to Investigation of the effect of manual therapy and pelvic floor exercises on pelvic floor muscle in women with constipation. The main question\[s\] it aims to answer are:

* In addition to pelvic floor exercises, manual therapy applied to the pelvic floor muscles has no impact on constipation.
* In addition to pelvic floor exercises, manual therapy applied to the pelvic floor muscles has an impact on constipation.

Participants will apply pelvic floor exercises and manual therapy techniques. If there is a comparison group: Researchers will compare \[insert groups\] to see if \[insert effects\].

Detailed Description

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* Female participants aged 18-55 years with constipation complaints will be recruited through social media and hospital outpatient clinics, and those who volunteer to participate will be enrolled in the study.
* Participants will be assessed as group 1 (pelvic floor exercises), group 2 (pelvic floor exercises + manual therapy techniques). Group 1 will receive diaphragmatic breathing training and then pelvic floor exercises to strengthen the pelvic floor.
* Group 2 will receive manual therapy methods consisting of Momentum Minus Mobilisation, Sphincter Opening, Colon Massage, Global Fascial Manipulation, Trigger Point and Myofascial Release in addition to Diaphragmatic Breathing Training and Pelvic Floor Exercises.
* Participants will receive exercise training 5 days a week for 6 weeks. Manual therapy methods will be used 2 days a week for the first 2 weeks and then 1 day a week. Initial assessment of participants and manual therapy applications will be done face to face. The exercises will be continued using the online telerehabilitation method.
* Both groups will be given nutritional advice, such as drinking plenty of water, eating fibre-rich foods and preferring foods that aid digestion. Participants will be advised to take their time every day, in the morning, at the same time, without rushing to defecate, preferring an squat toilet, which increases intra-abdominal pressure, half an hour after meals, but not for more than five minutes.If a European toilet is used, toilet training will be given about leaving a 15-18 cm long ridge under the feet.
* Both groups will be given assessment tests before and at the end of the trial and the results will be compared.

Conditions

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Colonic Inertia Dyschezia Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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pelvic floor exercises

Diaphragmatic breathing training and Pelvic Floor Exercises will be applied.Participants will receive exercise training 5 days a week for 6 weeks.

Group Type ACTIVE_COMPARATOR

pelvic floor exercises

Intervention Type OTHER

First arm; Pelvic Floor Exercises (PFE) consisting of diaphragm breathing training, bridge exercise to strengthen the pelvic floor, 3-dimensional diaphragm exercise, 'I Love you massage' for intestinal motility, happy baby pose, child position exercise, full squat, adductor and iliopsoas stretching, mermaid position exercise, 'Shhh' sound exercise, 'Üüüü' sound exercise will be applied.

Pelvic floor exercises and manual therapy techniques

In addition to diaphragmatic breathing training and pelvic floor exercises, manual therapy methods will be applied. Participants will receive exercise training 5 days a week for 6 weeks. Manual therapy methods will be used 2 days a week for the first 2 weeks and then 1 day a week.

Group Type ACTIVE_COMPARATOR

Pelvic floor exercises and manual therapy techniques

Intervention Type OTHER

Second arm; Pelvic Floor Exercises (PFE) consisting of diaphragm breathing training, bridge exercise to strengthen the pelvic floor, 3-dimensional diaphragm exercise, 'I Love you massage' for intestinal motility, happy baby pose, child position exercise, full squat, adductor and iliopsoas stretching, mermaid position exercise, 'Shhh' sound exercise, 'Üüüü' sound exercise will be applied. In addition to diaphragmatic breathing training and pelvic floor exercises, manual therapy methods such as momentum minus mobilisation, sphincter opening, colon massage, global fascia manipulation, trigger point and myofascial release will be applied.

Interventions

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pelvic floor exercises

First arm; Pelvic Floor Exercises (PFE) consisting of diaphragm breathing training, bridge exercise to strengthen the pelvic floor, 3-dimensional diaphragm exercise, 'I Love you massage' for intestinal motility, happy baby pose, child position exercise, full squat, adductor and iliopsoas stretching, mermaid position exercise, 'Shhh' sound exercise, 'Üüüü' sound exercise will be applied.

Intervention Type OTHER

Pelvic floor exercises and manual therapy techniques

Second arm; Pelvic Floor Exercises (PFE) consisting of diaphragm breathing training, bridge exercise to strengthen the pelvic floor, 3-dimensional diaphragm exercise, 'I Love you massage' for intestinal motility, happy baby pose, child position exercise, full squat, adductor and iliopsoas stretching, mermaid position exercise, 'Shhh' sound exercise, 'Üüüü' sound exercise will be applied. In addition to diaphragmatic breathing training and pelvic floor exercises, manual therapy methods such as momentum minus mobilisation, sphincter opening, colon massage, global fascia manipulation, trigger point and myofascial release will be applied.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Constipation in the last 6 months
* Being able to use smartphones and social media (whatsapp and instagram)
* Not having a health problem that prevents exercise
* Able to communicate
* Literate

Exclusion Criteria

* Not had constipation in the last 6 months
* Pregnancy or recent pregnancy
* had surgery
* having a tumour
* Having vertigo Taking medication (use of bowel-regulating drugs)
* Previous physiotherapy for constipation problems
* Inflammatory bowel disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul Arel University

OTHER

Sponsor Role lead

Responsible Party

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Cihan Islek

master's degree student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Serhad Bekir Sünbül

Role: STUDY_CHAIR

Cizre Dr. Selahattin Cizrelioğlu Devlet Hastanesi

Locations

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Cizre Dr Selahattin Cizrelioglu State Hospital

Şırnak, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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islek

Role: CONTACT

+905442755137

Halis Doğan, phd

Role: CONTACT

+90532 200 08 43

Facility Contacts

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serhad bekir sünbül

Role: primary

+905458551512

References

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Rao SS, Bharucha AE, Chiarioni G, Felt-Bersma R, Knowles C, Malcolm A, Wald A. Functional Anorectal Disorders. Gastroenterology. 2016 Mar 25:S0016-5085(16)00175-X 10.1053/j.gastro.2016.02.009. doi: 10.1053/j.gastro.2016.02.009. Online ahead of print.

Reference Type BACKGROUND
PMID: 27144630 (View on PubMed)

Other Identifiers

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2024/02

Identifier Type: -

Identifier Source: org_study_id

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