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 | Not Yet Recruiting

• 1 other identifier: 202502004RINB
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Kegel exercise; Biofeedback therapy; Bowel dysfunction; Emotional distress; Quality of life; Rectal cancer patients; Pelvic floor muscle training; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Bowel Function Measured by the Low Anterior Resection Syndrome (LARS) Score

  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

Secondary Outcomes (2)

• Change in Emotional Distress Measured by the Hospital Anxiety and Depression Scale (HADS)

  Baseline, 4 weeks, 8 weeks, and 12 weeks after intervention

• The World Health Organization Quality of Life Assessment-BREF (WHOQOL-BREF)

  Baseline, 4 weeks, 8 weeks, and 12 weeks after intervention

Study Arms (2)

Kegel Exercise with Biofeedback Therapy

EXPERIMENTAL

Behavioral: Kegel Exercise with Biofeedback

Kegel Exercise Only

ACTIVE COMPARATOR

Behavioral: Kegel Exercise Only

Interventions

Kegel Exercise with Biofeedback BEHAVIORAL

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.

Also known as: Kegel Exercise with Biofeedback (Kegel + BFT)

Kegel Exercise with Biofeedback Therapy

Kegel Exercise Only BEHAVIORAL

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.

Also known as: Kegel Exercise

Kegel Exercise Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Rectal Neoplasms; Low Anterior Resection Syndrome; Intestinal Diseases

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Colonic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Central Study Contacts

Chia Lin Hsu, RN, MSN-Candidate

CONTACT

+886-2-2312-3456; hsuchialin@ntuh.gov.tw

Kuei Fen Liu, RN, PhD

CONTACT

+886-2-2822-7101; kueifen@ntunhs.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Description: Data collectors were blinded to participant group assignment to reduce potential information bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a two-arm parallel group design comparing Kegel exercise combined with a single biofeedback therapy versus Kegel exercise alone.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share