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NCT Number: NCT06494917

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

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].

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cizre Dr Selahattin Cizrelioglu State Hospital

Şırnak, 732000, Turkey (Türkiye)

Location status: Recruiting

Location contact

serhad bekir sünbül

CONTACT

[email protected]

+905458551512

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pelvic floor exercises

Other

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 techniques

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Constipation Severity Scale

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

    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.

Other outcomes

  1. Bristol stool chart

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

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

  2. Rome IV Criteria

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

    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

  3. bowel diary

    Time frame: During the 6-week study

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

Study contacts

Contact information is provided by the study sponsor or research team.

Halis Doğan, phd

CONTACT

[email protected]

+90532 200 08 43

islek

CONTACT

[email protected]

+905442755137

Sponsors and collaborators

Lead sponsor

Istanbul Arel University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 10, 2024
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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