The Effects of Kegel Exercise Combined With Biofeedback Therapy on Bowel Function Recovery, Emoti… (NCT07253298) | Clinical Trial Compass
By InvitationNot Applicable
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
Taiwan66 participantsStarted 2026-01-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Bowel Function Measured by the Low Anterior Resection Syndrome (LARS) Score
Timeframe: Baseline, 4 weeks, 8 weeks, and 12 weeks after intervention