- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07253298
Effekterna av Kegel-träning kombinerat med biofeedbackterapi på återhämtning av tarmfunktion, känslomässig stress och livskvalitet hos patienter efter låg anteriör resektion för rektalcancer (BFT in LARS)
Effekter av Kegelövningar kombinerade med en enda biofeedbackintervention på tarmfunktion, emotionell stress och livskvalitet hos patienter efter rektalcanceroperation
This randomized controlled trial aims to evaluate the effects of combining Kegel exercise with a single biofeedback session on bowel function, emotional distress, and quality of life in patients who have undergone low anterior resection (LAR) for rectal cancer. Low anterior resection syndrome (LARS) is a common postoperative complication following LAR, characterized by increased stool frequency, urgency, and incontinence, which can significantly impair patients' psychological well-being and daily quality of life. Participants will be randomly assigned to one of two groups: (1) Kegel exercise combined with one non-invasive biofeedback session, or (2) Kegel exercise alone. Both groups will perform home-based Kegel exercises for eight weeks. The study aims to determine whether the combined biofeedback and Kegel exercise intervention results in greater improvements in bowel control, emotional well-being, and quality of life compared with Kegel exercise alone.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
Background:
Patients who undergo low anterior resection (LAR) for rectal cancer often experience low anterior resection syndrome (LARS), characterized by frequent bowel movements, urgency, and incontinence. These symptoms can cause considerable psychological distress and impair daily functioning. Pelvic floor muscle training (PFMT, commonly known as Kegel exercise) is a widely used bowel rehabilitation method; however, its effectiveness depends on patients' ability to perform the exercises correctly. Biofeedback therapy (BFT) provides real-time visual and auditory feedback to help patients better control pelvic floor muscle contractions and relaxations, thereby improving training precision.
Objective:
To examine whether combining a single biofeedback intervention with Kegel exercise produces greater improvements in bowel function, emotional distress, and quality of life than Kegel exercise alone in patients after low anterior resection for rectal cancer.
Methods:
This is a prospective randomized controlled trial (IRB No. 202502004RINB) to be conducted at National Taiwan University Hospital. A total of 66 eligible participants who have completed at least four weeks after LAR will be recruited. Participants will be randomized (1:1) into experimental and control groups using block randomization with block sizes of 4, 6, or 8.
The experimental group will receive one 30-minute session of non-invasive electromyographic biofeedback training to correct pelvic floor muscle contraction and relaxation techniques, followed by Kegel exercise instruction. The control group will receive only verbal instruction and demonstration of Kegel exercises without the use of biofeedback devices.
Both groups will continue home-based Kegel exercises for eight weeks, with a total follow-up period of twelve weeks. Assessments will be conducted at four time points: baseline (T0), 4 weeks (T1), 8 weeks (T2), and 12 weeks (T3).
Outcome Measures:
Primary outcome: Low Anterior Resection Syndrome Score (LARS Score). Secondary outcomes: Hospital Anxiety and Depression Scale (HADS), The World Health Organization Quality of Life Assessment-BREF Taiwan version (WHOQOL-BREF Taiwan version).
Expected Results:
The experimental group (Kegel exercise combined with single-session biofeedback) is expected to demonstrate greater improvements in bowel function, reduced emotional distress, and enhanced quality of life compared with the Kegel-only group.
Significance:
This study aims to establish a low-cost, non-invasive, and feasible postoperative rehabilitation approach to enhance bowel recovery and improve the quality of life in patients after rectal cancer surgery.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Taipei, Taiwan, 100
- National Taiwan University Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Patients who have undergone their first low anterior resection (LAR) for rectal cancer, or LAR with temporary stoma reversal at least 4 weeks prior to enrollment.
- Age ≥ 18 years.
- Hemodynamically stable with stable vital signs.
- Conscious, able to communicate in Mandarin or Taiwanese, and capable of following verbal instructions to perform exercises.
Exclusion Criteria:
- Presence of a current intestinal stoma.
- Implanted cardiac pacemaker.
- Scheduled to receive postoperative adjuvant radiotherapy.
- History of psychiatric disorders (e.g., depression).
- Postoperative complications such as anastomotic leakage, intra-abdominal infection, or fistula formation.
- Unable to cooperate with or complete biofeedback training.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Kegelövningar med biofeedbackterapi
|
A single 30-minute non-invasive EMG biofeedback session will guide participants to correctly contract and relax pelvic floor muscles using real-time visual and auditory feedback. Conducted by trained healthcare staff in the physical therapy center, with additional outpatient or ward instruction if needed. After the session, participants perform home-based Kegel exercises for 8 weeks (3-5 times/day, 6-8 contractions/set, hold 5-10 sec, relax 10 sec, ≥5 days/week). Research staff will follow up every 1-2 weeks by phone to monitor adherence and adjust intensity. If stable 5-sec contractions are achieved, duration or frequency may increase; if fatigue, abdominal pressure, or discomfort occurs, training will be reduced or paused for safety.
Andra namn:
|
|
Aktiv komparator: Kegelövning Endast
|
Participants in the control group will receive a single 30-minute session of verbal instruction and demonstration on Kegel exercise by trained medical personnel, without the use of any biofeedback device. The provider, setting, duration, exercise dosage, and follow-up schedule are identical to those in the experimental group.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Bowel Function Measured by the Low Anterior Resection Syndrome (LARS) Score
Tidsram: Baseline, 4 weeks, 8 weeks, and 12 weeks after intervention
|
Bowel function will be assessed using the validated Low Anterior Resection Syndrome (LARS) score, which consists of five items evaluating incontinence, frequency, clustering, and urgency. The total score ranges from 0 to 42, with higher scores indicating more severe bowel dysfunction. |
Baseline, 4 weeks, 8 weeks, and 12 weeks after intervention
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Emotional Distress Measured by the Hospital Anxiety and Depression Scale (HADS)
Tidsram: Baseline, 4 weeks, 8 weeks, and 12 weeks after intervention
|
Emotional distress will be measured using the Hospital Anxiety and Depression Scale (HADS), which includes 14 items divided into two subscales: anxiety (HADS-A) and depression (HADS-D). Each subscale has a score range of 0-21, with higher scores indicating greater emotional distress. |
Baseline, 4 weeks, 8 weeks, and 12 weeks after intervention
|
|
The World Health Organization Quality of Life Assessment-BREF (WHOQOL-BREF)
Tidsram: Baseline, 4 weeks, 8 weeks, and 12 weeks after intervention
|
Quality of life will be assessed using the WHOQOL-BREF Taiwan version, a 28-item instrument developed by the WHOQOL Group and culturally adapted for use in Taiwan. The scale measures four major domains-Physical Health, Psychological Health, Social Relationships, and Environment-as well as two national items relevant to local culture. Scores in each domain are transformed to a 4-20 scale, with higher scores indicating better perceived quality of life. |
Baseline, 4 weeks, 8 weeks, and 12 weeks after intervention
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Postoperativa komplikationer
- Patologiska processer
- Neoplasmer efter plats
- Neoplasmer
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Matsmältningssystemets sjukdomar
- Gastrointestinala sjukdomar
- Kolorektala neoplasmer
- Intestinala neoplasmer
- Rektala sjukdomar
- Kolonsjukdomar
- Patologiska tillstånd, tecken och symtom
- Low Anterior Resection Syndrome
- Rektal neoplasmer
- Tarmsjukdomar
- Terapeutik
- Mind-body terapier
- Kompletterande behandlingar
- Beteendebehandling
- Psykoterapi
- Beteendediscipliner och aktiviteter
- Feedback, psykologisk
- Biofeedback, psykologi
Andra studie-ID-nummer
- 202502004RINB
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .