케겔 운동과 바이오피드백 치료를 병행한 저위 전방 절제술을 받은 직장암 환자의 장 기능 회복, 정서적 고통 및 삶의 질에 미치는 영향 (BFT in LARS)
직장암 수술 후 환자의 장 기능, 정서적 고통 및 삶의 질에 대한 케겔 운동과 단일 바이오피드백 중재의 병용 효과
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Taipei, 대만, 100
- National Taiwan University Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 바이오피드백 치료와 함께하는 케겔 운동
|
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.
다른 이름들:
|
|
활성 비교기: 케겔 운동만
|
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.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Bowel Function Measured by the Low Anterior Resection Syndrome (LARS) Score
기간: 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. |
Baseline, 4 weeks, 8 weeks, and 12 weeks after intervention
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Emotional Distress Measured by the Hospital Anxiety and Depression Scale (HADS)
기간: Baseline, 4 weeks, 8 weeks, and 12 weeks after intervention
|
Emotional distress will be measured using the Hospital Anxiety and Depression Scale (HADS), which includes 14 items divided into two subscales: anxiety (HADS-A) and depression (HADS-D). Each subscale has a score range of 0-21, with higher scores indicating greater emotional distress. |
Baseline, 4 weeks, 8 weeks, and 12 weeks after intervention
|
|
The World Health Organization Quality of Life Assessment-BREF (WHOQOL-BREF)
기간: Baseline, 4 weeks, 8 weeks, and 12 weeks after intervention
|
Quality of life will be assessed using the WHOQOL-BREF Taiwan version, a 28-item instrument developed by the WHOQOL Group and culturally adapted for use in Taiwan. The scale measures four major domains-Physical Health, Psychological Health, Social Relationships, and Environment-as well as two national items relevant to local culture. Scores in each domain are transformed to a 4-20 scale, with higher scores indicating better perceived quality of life. |
Baseline, 4 weeks, 8 weeks, and 12 weeks after intervention
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 202502004RINB
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .