The Effect of Pelvic Floor Muscle Training in Functional Constipation
27 maggio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Stato
Attivo, non reclutante
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Interventistico
Iscrizione (Stimato)
Iscrizione
28
Fase
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Bornova
-
Izmir, Bornova, Turchia (Türkiye), 35080
- Ege university
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Numero di armi
2
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Comparatore attivo: 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.
|
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Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Constipation Quality of Life Scale
Lasso di tempo: 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
Lasso di tempo: 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.
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initially, 4th week, 8th week
|
|
Electromyographic (EMG) Measurement
Lasso di tempo: 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
|
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Bristol Stool Form Scale
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
22 dicembre 2025
Completamento primario (Stimato)
Completamento primario
22 maggio 2026
Completamento dello studio (Stimato)
Completamento dello studio
22 luglio 2026
Date di iscrizione allo studio
Primo inviato
Primo inviato
18 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
18 maggio 2026
Primo Inserito (Effettivo)
Primo Inserito
22 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
29 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
27 maggio 2026
Ultimo verificato
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 2026/05
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .