Clinical trial · Interventional
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| LARS - Low Anterior Resection Syndrome | — | UNRESOLVED | — |
| Low Anterior Resection Syndrome | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Kegel Exercise Only | Behavioral | — | UNRESOLVED |
| Kegel Exercise with Biofeedback | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Kegel Exercise with Biofeedback Therapy
- interventionNames
- Behavioral: Kegel Exercise with Biofeedback
- type
- ACTIVE_COMPARATOR
- label
- Kegel Exercise Only
- interventionNames
- Behavioral: Kegel Exercise Only
Primary outcomes (1)
- measure
- Change in Bowel Function Measured by the Low Anterior Resection Syndrome (LARS) Score
- timeFrame
- Baseline, 4 weeks, 8 weeks, and 12 weeks after intervention
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available