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The Effects of Kegel Exercise Combined With Biofeedback Therapy on Bowel Function Recovery, Emotional Distress, and Quality of Life in Patients Following Low Anterior Resection for Rectal Cancer

NCT07253298 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-05-11

No results posted yet for this study

Summary

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.

Conditions

  • Rectal Cancer
  • Low Anterior Resection Syndrome
  • LARS - Low Anterior Resection Syndrome

Interventions

BEHAVIORAL

Kegel Exercise with Biofeedback

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.

BEHAVIORAL

Kegel Exercise Only

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.

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-05
Primary Completion
2026-12-31
Completion
2027-01-31

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07253298 on ClinicalTrials.gov