Colonic InertiaNCT06494917
Investigation of the Effect of Manual Therapy and Pelvic Floor Exercises on Pelvic Floor Muscles
A study testing pelvic floor exercises and Pelvic floor exercises and manual therapy techniques in people with Colonic Inertia and Dyschezia, run by Istanbul Arel University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Colonic Inertia, Dyschezia, Constipation
- What is being tested?
- pelvic floor exercises and Pelvic floor exercises and manual therapy techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jun 2024to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Cizre Dr Selahattin Cizrelioglu State Hospital
Şırnak, 732000
serhad bekir sünbül, +905458551512, fzt.bekirsunbul@gmail.com
About this study
Official title: 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].
Read the 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.
- Conditions
- Colonic Inertia, Dyschezia, Constipation
- Being tested
- pelvic floor exercises, Pelvic floor exercises and manual therapy techniques
- Keywords
- constipation, pelvic floor, manual therapy, exercise
- Medical subject headings
- Constipation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic floor exercisesOther
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 techniquesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Pelvic floor exercises and manual therapy techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: will be evaluated at the first session and at the end of session 6
Secondary outcomes (1)
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.
Measured: will be evaluated at the first session and at the end of session 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start14 Jun 2024
- Primary completionAug 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonic InertiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Arel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cihan Islek, Istanbul Arel University
- Investigators
- Serhad Bekir Sünbül, Study chair, Cizre Dr. Selahattin Cizrelioğlu Devlet Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494917
- Sponsor's protocol ID
- 2024/02
- Status last verified
- Jul 2024
- First submitted
- 2 Jun 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27144630
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Manual Therapy and Pelvic Floor Exercises on Pelvic Floor Muscles in Women With Constipation
- ClinicalTrials.gov ID
- NCT06494917
- Acronym / sponsor ID
- 2024/02
- Conditions
- Colonic Inertia, Dyschezia, Constipation
- Keywords
- constipation, pelvic floor, manual therapy, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Istanbul Arel UniversityUniversity, hospital or other
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pelvic floor exercises | Active comparator | Other: pelvic floor exercisesDiaphragmatic 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 comparator | Other: Pelvic floor exercises and manual therapy techniquesIn 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pelvic floor exercisesFirst 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. | Other | pelvic floor exercises |
| Pelvic floor exercises and manual therapy techniquesSecond 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. | Other | Pelvic floor exercises and manual therapy techniques |
Primary outcome
Constipation Quality of Life questionnaire
Time frame: will be evaluated at the first session and at the end of session 6
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.
1 secondary outcome
Constipation Severity Scale
Time frame: will be evaluated at the first session and at the end of session 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Background: PubMed 27144630Rao 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serhad Bekir Sünbül study chair
Cizre Dr. Selahattin Cizrelioğlu Devlet Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pelvic floor exercises and Pelvic floor exercises and manual therapy techniques in people with Colonic Inertia and Dyschezia, run by Istanbul Arel University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact islek (+905442755137, cihanislek97@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constipation Quality of Life questionnaire (time frame: will be evaluated at the first session and at the end of session 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06494917, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.