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

Официальное название

Effects of Kegel Exercise Combined With a Single Biofeedback Intervention on Bowel Function, Emotional Distress, and Quality of Life in Patients After Rectal Cancer Surgery

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 ev
• Поведенческое 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.

Первичные конечные точки

• Change in Bowel Function Measured by the Low Anterior Resection Syndrome (LARS) Score [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks after intervention]

Вторичные конечные точки (2)

• Change in Emotional Distress Measured by the Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks after intervention]
• The World Health Organization Quality of Life Assessment-BREF (WHOQOL-BREF) [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks after intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• National Taiwan University Hospital — Taipei

Идентификаторы

NCT: NCT07253298 · 202502004RINB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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