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RecruitingNCT06494917Updated Jul 15, 2024

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

An interventional study of pelvic floor exercises and Pelvic floor exercises and manual therapy techniques in Colonic Inertia, Dyschezia and Constipation, sponsored by Istanbul Arel University. Recruiting at 1 site in Turkey. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-15.

Sponsored by Istanbul Arel University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
  • Started Jun 2024; still recruiting 2 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Female
01

Study 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].

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.
02

Conditions studied

  • Colonic Inertia
  • Dyschezia
  • Constipation

Browse trials for

Keywords

  • constipation
  • pelvic floor
  • manual therapy
  • exercise
03

In context

Constipation

1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.

This study's planned enrollment of 44 is below the median of 80 across 850 interventional studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

Istanbul Arel University is the lead sponsor of 44 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
44 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Otherpelvic 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.

  • OtherPelvic 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.

06

What researchers measure

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.

    Time frame: 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.

    Time frame: will be evaluated at the first session and at the end of session 6

Other outcomes

  1. Bristol stool chart

    Bristol stool chart is a medical aid designed to classify faeces into seven groups.

    Time frame: will be evaluated at the first session and at the end of session 6

  2. 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

    Time frame: will be evaluated at the first session and at the end of session 6

  3. bowel diary

    a record you keep of when and how much faeces (poo) you passed or leaked during the day and overnight.

    Time frame: During the 6-week study

07

Study locations

1 of 1 sites recruiting
  • Cizre Dr Selahattin Cizrelioglu State Hospital
    Şırnak, 732000, Turkey
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06494917
Lead sponsor
Istanbul Arel University
Responsible party
Cihan Islek (master's degree student, Istanbul Arel University) — Principal investigator
First posted
Jul 10, 2024
Start date
Jun 14, 2024
Primary completion
Aug 2024 (estimated)
Completion
Sep 2024 (estimated)
Last update
Jul 15, 2024

Study contacts

islek
Contact
cihanislek97@gmail.com
+905442755137
Halis Doğan, phd
Contact
halisdogan@arel.edu.tr
+90532 200 08 43
Serhad Bekir Sünbül
study chair · Cizre Dr. Selahattin Cizrelioğlu Devlet Hastanesi

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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