About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Exercise
Other interventionstructured walking exercise, at the clinic and outside from the clinic for at least 3 days /week
guided imagery
Behavioralguided imagery for at least 3 days
Treatment groups
Trial outcomes
Primary outcomes
Low Anterior Resection Sydrome scoring system
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
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
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
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.
Secondary outcomes
colorectoanal distress inventory
It measures the intensity of anorectal symptoms. The score ranges from 0 to 100, with higher scores indicating greater colorectal and anal symptom distress.
wexner questionnaire
It measures the intensity of fecal incontinence. The score ranges from 0 to 20, with higher scores indicating greater severity of fecal incontinence.
International Physical Activity Questionnaire-short form
It measures the level of physical activity level. The questionnaire assesses physical activity levels in MET-minutes/week.Higher MET-minutes/week indicate greater physical activity.
Hospital Anxiety and Depression Scale
It measures the level of depression and anxiety. The Hospital Anxiety and Depression Scale (HADS) consists of two subscales (anxiety and depression), each ranging from 0 to 21. Higher scores indicate greater symptoms of anxiety or depression.
Sponsors and contacts
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