Clinical trial NCT06494917: Investigation of the Effect of Manual Therapy and Pelvic Floor Exercises on Pelvic Floor Muscles
Official title: Investigation of the Effect of Manual Therapy and Pelvic Floor Exercises on Pelvic Floor Muscles in Women With Constipation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colonic Inertia
Dyschezia
Constipation
Keywords: constipation
pelvic floor
manual therapy
exercise
Lead sponsor: Istanbul Arel University
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: * 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.

Eligibility criteria: 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

Primary outcomes:
measure: Constipation Quality of Life questionnaire
timeFrame: will be evaluated at the first session and at the end of session 6
Secondary outcomes:
measure: Constipation Severity Scale
timeFrame: will be evaluated at the first session and at the end of session 6
Other outcomes:
measure: Bristol stool chart
timeFrame: will be evaluated at the first session and at the end of session 6
measure: Rome IV Criteria
timeFrame: will be evaluated at the first session and at the end of session 6
measure: bowel diary
timeFrame: During the 6-week study
Locations:
city: Şırnak
country: Turkey
facility: Cizre Dr Selahattin Cizrelioglu State Hospital
Study officials:
affiliation: Cizre Dr. Selahattin Cizrelioğlu Devlet Hastanesi
name: Serhad Bekir Sünbül
role: STUDY_CHAIR
References:
citation: 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.