The Effect of Pelvic Floor Muscle Training in Functional Constipation
27. mai 2026 oppdatert av: Selin Koşan
The Effect of Pelvic Floor Muscle Training on Symptoms, Core Muscle Function, and Quality of Life in Functional Constipation
The aim of this study is to examine the effect of individualized pelvic floor muscle training on symptoms, core muscle function, and quality of life in patients with functional constipation.The research is being conducted at the Department of Internal Medicine, Gastroenterology Division, Faculty of Medicine, Ege University.The study group received diaphragmatic breathing exercises, lifestyle modification training, and individualized pelvic floor muscle training, while the control group received diaphragmatic breathing exercises and lifestyle modification training.
These treatments were applied to the patients for 8 weeks.
Demographic information was recorded using a data record form.
Frequency of bowel movements, stool types and shapes were assessed using the Bristol Stool Scale, muscle function using superficial electromyography (EMG), quality of life using the Constipation Quality of Life Scale, and severity of constipation using the Constipation Severity Scale.
All assessments were repeated at weeks 4 and 8.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
28
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Bornova
-
Izmir, Bornova, Tyrkia (Türkiye), 35080
- Ege university
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Female cases diagnosed with functional constipation (according to ROMA IV criteria)
- Over 18 years of age and under 70 years of age
- According to ROMA IV criteria:
- Onset of symptoms at least 6 months prior to diagnosis, and experiencing any two or more of the following symptoms in the last 12 weeks (not necessarily consecutive): a) straining during at least 25% of defecations, b) hard stools in at least 25% of defecations, c) feeling of incomplete bowel movements in at least 25% of defecations, d) feeling of anorectal blockage/obstruction in at least 25% of defecations, e) needing to empty the rectum (supporting the pelvic floor muscles), and f) fewer than three bowel movements per week
- Very rare achievement of soft stools without laxative use
- Having insufficient criteria for irritable bowel syndrome,
- Ready to write in Turkish
- Cases who have signed the informed consent form will be included in the study.
Exclusion Criteria:
- Patients with secondary constipation (metabolic, endocrine, and neurological)
- Patients with slow transit constipation
- Patients with major orthopedic limitations that may affect the study
- Patients with megacolon, pseudo-obstruction, and severe anorectal disorders (Grade 3-4 hemorrhoidal disease, anal fissure, anal fistula, anorectal abscess, pilonidal sinus, etc.)
- Patients who have undergone pelvic floor surgery, coloproctological surgery, bridileus surgery, or similar major abdominal surgery (excluding appendectomy)
- Patients with drug-induced constipation
- Patients with any serious systemic disorder including heart, lung, gastrointestinal system, or uncontrolled diabetes mellitus
- Patients with cognitive difficulties that would hinder the conduct of the study (Mini Mental Test score <24)
- Patients with major psychiatric problems that may affect the study
- Pregnant patients will be excluded.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: control
The control group receives diaphragmatic breathing exercises and lifestyle modification training.
|
Patients are advised to increase their physical activity levels.
Toilet training includes: not ignoring the urge to defecate, using correct posture during defecation, leaning forward with knees higher than hips when sitting on the toilet, and supporting the feet on a step to correct the anorectal angle.
This training is supported by images.
They are also instructed to use deep relaxation techniques during defecation, avoid straining, and not stay on the toilet for longer than 10 minutes.
Dietary changes include: drinking a warm caffeinated beverage upon waking, having breakfast within an hour of waking, increasing daily fluid intake to 1.5-2 liters, and increasing dietary fiber to 25-30 grams daily, but doing so slowly to prevent abdominal cramps and bloating.
Lifestyle changes are monitored daily.
Diary entries are requested weekly for 8 weeks via mobile phone application/email.
The mechanism of constipation and the purpose of diaphragmatic breathing exercises will be explained to the patients.
Patients will be instructed to begin the diaphragmatic breathing exercise in a seated position with one hand on their abdomen and the other on their chest, with their feet 20 cm above the ground.
They will then inhale slowly, deeply, and gradually for 6-8 seconds, hold their breath for 10 seconds, and exhale slowly over 6-8 seconds.
While inhaling deeply, they will be asked to expand their abdomen by raising their hands from their abdomen while keeping their hands on their chest stationary.
Patients will be advised to perform this exercise 3 times a day (especially in the toilet) for 15 breaths each time.
|
|
Eksperimentell: pelvic floor muscle training
The functional status of the pelvic floor muscles is determined based on the results obtained from EMG data and the type of Pelvic Floor Muscle Training is determined.
PTKE is applied individually, tailored to the functional status of the pelvic floor muscles.
Before the exercise, patients are taught correct and effective pelvic floor muscle contraction and relaxation techniques through external palpation of the perineum and abdominal region.
Patients are instructed to relax their pelvic floor muscles as if urinating or defecating while inhaling through their nose, feeling the area descend, and to contract their pelvic floor muscles as if holding back urine or stool while exhaling.
Relaxing the levator ani muscle durmuscle during straining and proper breathing techniques are re-taught.
The duration of pelvic floor muscle training is initially kept short and gradually increased.
Under these conditions, sessions are held once a week, lasting approximately 30-45 minutes.
|
Patients are advised to increase their physical activity levels.
Toilet training includes: not ignoring the urge to defecate, using correct posture during defecation, leaning forward with knees higher than hips when sitting on the toilet, and supporting the feet on a step to correct the anorectal angle.
This training is supported by images.
They are also instructed to use deep relaxation techniques during defecation, avoid straining, and not stay on the toilet for longer than 10 minutes.
Dietary changes include: drinking a warm caffeinated beverage upon waking, having breakfast within an hour of waking, increasing daily fluid intake to 1.5-2 liters, and increasing dietary fiber to 25-30 grams daily, but doing so slowly to prevent abdominal cramps and bloating.
Lifestyle changes are monitored daily.
Diary entries are requested weekly for 8 weeks via mobile phone application/email.
The mechanism of constipation and the purpose of diaphragmatic breathing exercises will be explained to the patients.
Patients will be instructed to begin the diaphragmatic breathing exercise in a seated position with one hand on their abdomen and the other on their chest, with their feet 20 cm above the ground.
They will then inhale slowly, deeply, and gradually for 6-8 seconds, hold their breath for 10 seconds, and exhale slowly over 6-8 seconds.
While inhaling deeply, they will be asked to expand their abdomen by raising their hands from their abdomen while keeping their hands on their chest stationary.
Patients will be advised to perform this exercise 3 times a day (especially in the toilet) for 15 breaths each time.
The functional status of the pelvic floor muscles is determined based on the results obtained from EMG data and the type of Pelvic Floor Muscle Training is determined.
PTKE is applied individually, tailored to the functional status of the pelvic floor muscles.
Before the exercise, patients are taught correct and effective pelvic floor muscle contraction and relaxation techniques through external palpation of the perineum and abdominal region.
Patients are instructed to relax their pelvic floor muscles as if urinating or defecating while inhaling through their nose, feeling the area descend, and to contract their pelvic floor muscles as if holding back urine or stool while exhaling.
Relaxing the levator ani muscle durmuscle during straining and proper breathing techniques are re-taught.
The duration of pelvic floor muscle training is initially kept short and gradually increased.
Under these conditions, sessions are held once a week, lasting approximately 30-45 minutes.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Constipation Quality of Life Scale
Tidsramme: initially, 4th week, 8th week
|
The quality of life of the subjects is measured using the Constipation Quality of Life Scale.
It consists of a total of 28 items: "worry/anxiety" (11 items), "physical discomfort" (4 items), "psychosocial discomfort" (8 items), and "satisfaction" (5 items).
The scale score ranges from 28 to 140, with a higher score indicating a negative impact on quality of life.
|
initially, 4th week, 8th week
|
|
Constipation Severity Scale
Tidsramme: initially, 4th week, 8th week
|
The severity of constipation will be assessed using the Constipation Severity Scale (CSS).
The CSS is a scale designed to determine the frequency, intensity, and difficulty/hardship of bowel movements.
It can also be used to measure constipation symptoms.
The minimum total score on the scale is "0", and the maximum is "73".
Higher scores indicate greater severity of constipation symptoms.
|
initially, 4th week, 8th week
|
|
Electromyographic (EMG) Measurement
Tidsramme: initially, 4th week, 8th week
|
Electromyographic measurement will be used to record the bioelectrical activity generated by the internal oblique abdominals, transversus abdominis, and levator ani muscles in µV.
First, patients will be asked to relax all their muscles when given the command "relax," to contract their muscles as strongly as possible when given the command "muscle," and to initiate defecation as if using a toilet when given the command "strain."
Patients will be asked not to contract their abdominal, gluteal, and adductor muscles during each assessment.
|
initially, 4th week, 8th week
|
|
Bristol Stool Form Scale
Tidsramme: initially, 4th week,8th week
|
Stool consistency will be assessed using the Bristol Stool Form Scale.
The scale is scored from 1 to 7, with lower scores indicating harder stools and higher scores indicating looser or watery stools.
Types 1-2 represent hard/lumpy stools associated with constipation, whereas types 6-7 indicate loose/watery stools associated with diarrhea.
Higher scores indicate worse stool consistency outcomes.
|
initially, 4th week,8th week
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
22. desember 2025
Primær fullføring (Antatt)
22. mai 2026
Studiet fullført (Antatt)
22. juli 2026
Datoer for studieregistrering
Først innsendt
18. mai 2026
Først innsendt som oppfylte QC-kriteriene
18. mai 2026
Først lagt ut (Faktiske)
22. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 2026/05
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .