NCT06494917

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Completed
12 days until next milestone

Study Start

First participant enrolled

June 14, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 10, 2024

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

July 15, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

June 2, 2024

Last Update Submit

July 12, 2024

Conditions

Keywords

constipationpelvic floormanual therapyexercise

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 COMPARATOR

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

Pelvic floor exercises and manual therapy techniques

ACTIVE COMPARATOR

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

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.

pelvic floor exercises

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.

Pelvic floor exercises and manual therapy techniques

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBiological female
Healthy VolunteersYes
Age GroupsAdult (18-64)

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)

RECRUITING

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

ConstipationMotor Activity

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Serhad Bekir Sünbül

    Cizre Dr. Selahattin Cizrelioğlu Devlet Hastanesi

    STUDY CHAIR

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

Locations