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

Investigation of the Effect of Manual Therapy and Pelvic Floor Exercises on Pelvic Floor Muscles in Women With Constipation

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].

Study Overview

• Status: Recruiting
• Conditions: Constipation; Colonic Inertia; Dyschezia
• Intervention / Treatment: Other: pelvic floor exercises; Other: Pelvic floor exercises and manual therapy techniques

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.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: islek; Phone Number: +905442755137; Email: cihanislek97@gmail.com
• Study Contact Backup: Name: Halis Doğan, phd; Phone Number: +90532 200 08 43; Email: halisdogan@arel.edu.tr

Study Locations

• Turkey
  • Şırnak, Turkey, 732000
    • Recruiting
    • Cizre Dr Selahattin Cizrelioglu State Hospital
    • Contact: serhad bekir sünbül; Phone Number: +905458551512; Email: fzt.bekirsunbul@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constipation Quality of Life questionnaire	evaluates constipation through daily individual health assessment and functioning. The highest score that can be obtained from the scale is 140 and the lowest score is 28. It is thought that quality of life is negatively affected as scores on the scale increase.	will be evaluated at the first session and at the end of session 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constipation Severity Scale	scale that is calculated as a sum of a 5-point ordinal frequency ratings for the six Rome III (IV) functional constipation questions. The lowest score is 0 and the highest is 73. A high score on the scale indicates that the symptoms are at a severe level.	will be evaluated at the first session and at the end of session 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bristol stool chart	Bristol stool chart is a medical aid designed to classify faeces into seven groups.	will be evaluated at the first session and at the end of session 6
Rome IV Criteria	categorizes disorders of chronic constipation into four subtypes: (a) functional constipation, (b) irritable bowel syndrome with constipation, (c) opioid-induced constipation, and (d) functional defecation disorders, including inadequate defecatory propulsion and dyssynergic defecation	will be evaluated at the first session and at the end of session 6
bowel diary	a record you keep of when and how much faeces (poo) you passed or leaked during the day and overnight.	During the 6-week study

Collaborators and Investigators

• Sponsor: Istanbul Arel University
• Investigators: Study Chair: Serhad Bekir Sünbül, Cizre Dr. Selahattin Cizrelioğlu Devlet Hastanesi

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: June 2, 2024
• First Submitted That Met QC Criteria: July 7, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): July 15, 2024
• Last Update Submitted That Met QC Criteria: July 12, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: exercise; manual therapy; constipation; pelvic floor
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: 2024/02

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