Investigation of the Effect of Manual Therapy and Pelvic Floor Exercises on Pelvic Floor Muscles
1 other identifier
interventional
44
1 country
1
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 \[insert effects\].
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2024
CompletedStudy Start
First participant enrolled
June 14, 2024
CompletedFirst Posted
Study publicly available on registry
July 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedJuly 15, 2024
July 1, 2024
2 months
June 2, 2024
July 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Constipation Severity Scale
will be evaluated at the first session and at the end of session 6
Other Outcomes (3)
Bristol stool chart
will be evaluated at the first session and at the end of session 6
Rome IV Criteria
will be evaluated at the first session and at the end of session 6
bowel diary
During the 6-week study
Study Arms (2)
pelvic floor exercises
ACTIVE COMPARATORDiaphragmatic breathing training and Pelvic Floor Exercises will be applied.Participants will receive exercise training 5 days a week for 6 weeks.
Pelvic floor exercises and manual therapy techniques
ACTIVE COMPARATORIn 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cizre Dr Selahattin Cizrelioglu State Hospital
Şırnak, 732000, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 27144630BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Serhad Bekir Sünbül
Cizre Dr. Selahattin Cizrelioğlu Devlet Hastanesi
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- master's degree student
Study Record Dates
First Submitted
June 2, 2024
First Posted
July 10, 2024
Study Start
June 14, 2024
Primary Completion
August 1, 2024
Study Completion
September 1, 2024
Last Updated
July 15, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share