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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in Bowel Function Measured by the Low Anterior Resection Syndrome (LARS) Score
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Description: Data collectors were blinded to participant group assignment to reduce potential information bias.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Kegel Exercise Only
干预措施: Kegel Exercise Only (Behavioral)
Kegel Exercise with Biofeedback Therapy
干预措施: Kegel Exercise with Biofeedback (Behavioral)
结局指标
主要结局
Change in Bowel Function Measured by the Low Anterior Resection Syndrome (LARS) Score
时间窗: 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.
次要结局
- 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)