"The Effects of Aerobic Exercise and Guided Imagery on Low Anterior Resection Syndrome After Rectal Cancer Surgery: A Randomized Controlled Study"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Low Anterior Resection Sydrome scoring system
研究概览
简要总结
Low Anterior Resection Syndrome (LARS) is a common complication after sphincter-preserving rectal cancer surgery and may negatively affect bowel function and quality of life. Although exercise has been shown to improve physical function and well-being in cancer survivors, evidence regarding its effects on LARS symptoms remains limited.
This randomized controlled, multicenter study aims to evaluate the effects of an aerobic exercise program combined with guided imagery on bowel symptoms, quality of life, physical activity level, functional capacity, and psychological well-being in patients with LARS after rectal cancer surgery. Participants will be randomly assigned to either an intervention group receiving aerobic exercise and guided imagery in addition to standard care or a control group receiving standard care alone. Outcomes will be assessed at baseline and after the intervention period using validated clinical and patient-reported outcome measures.
The findings of this study may contribute to the development of evidence-based rehabilitation strategies for improving bowel function and quality of life in patients with LARS following rectal cancer surgery.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Upper-Middle-Lower Rectal Cancer
- •Having undergone surgery with TMJ
- •Having a protective ileostomy and a closed stoma
- •Being tumor-free according to laboratory reports (carcinoembryonic antigen), endoscopic findings, and abdominal ultrasonography and/or computed tomography data
- •Having at least minor LARS scores ("between 21" and "42") according to the -LARS scoring questionnaire
- •Having the ability to perform voluntary perineal traction contractions with perineal palpation
- •Being a volunteer with informed consent
排除标准
- •History of incontinence or defecation disorder not related to rectal cancer
- •Having another type of surgery for rectal cancer (Hartmann procedure, abdominoperineal excision, transanal endoscopic microsurgical resection, or sigmoid resection)
- •Deterioration in general health, neurological disease and/or physical disability
- •BMI > 30 kg/m2 (obese individuals)
- •Inability to answer questions or make interventions due to mental disorder
结局指标
主要结局
Low Anterior Resection Sydrome scoring system
时间窗: "From enrollment to the end of treatment at 8 weeks"
It measures the intensity of low anterior resection syndrome. The score varies between "0" and "42". Higher scores indicates more severe symptoms.
European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire-30
时间窗: 8 weeks from beginning the study
It measures the quality of life in cancer patients. The scores range from 0 to 100. For the Global Health Status and Functional Scales, higher scores indicate better health-related quality of life and functioning, whereas for the Symptom Scales, higher scores indicate greater symptom burden.
European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire-29
时间窗: 8 weeks
It measures the quality of life in cancer patients. The EORTC QLQ-CR29 scores range from 0 to 100. Higher scores on the functional scales indicate better functioning, whereas higher scores on the symptom scales indicate greater symptom burden.
6 minutes walking test
时间窗: 8 weeks
It measures the aerobic capacity within 6 minutes. The 6-Minute Walk Test (6MWT) assesses functional exercise capacity by measuring the total distance walked in meters over six minutes. There is no maximum value. Higher distances indicate better functional exercise capacity.
次要结局
- colorectoanal distress inventory(8 weeks)
- wexner questionnaire(8 weeks)
- International Physical Activity Questionnaire-short form(8 weeks)
- Hospital Anxiety and Depression Scale(8 weeks)
- pelvic floor muscle function via biofeedback(8 weeks)
研究者
Zeynep HOŞBAY
professor
Biruni University