Aerobic Exercise, Fecal Incontinence and Constipation, Guided Imagery Exercise, Pelvic Floor Muscle Training, Pelvic Floor Physical Therapy, Rectal Cancer
Conditions
Keywords
rectal cancer, low anterior resection syndrome, aerobic exercise, guided imagery, pelvic floor muscle training, pelvic floor rehabilitation, pelvic floor physical therapy
Brief summary
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.
Interventions
OTHERExercise
structured walking exercise, at the clinic and outside from the clinic for at least 3 days /week
BEHAVIORALguided imagery
guided imagery for at least 3 days
Sponsors
Biruni University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Low Anterior Resection Sydrome scoring system | "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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| colorectoanal distress inventory | 8 weeks | 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 | 8 weeks | 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 | 8 weeks | 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 | 8 weeks | 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. |
| pelvic floor muscle function via biofeedback | 8 weeks | It measures the strength of pelvic floor muscles. Pelvic floor muscle activity by using surface electromyography (sEMG) are reported in microvolts (µV). Therefore, there is no any min-max value. Higher EMG amplitudes indicate greater pelvic floor muscle activation. |
Countries
Turkey (Türkiye)
Contacts
CONTACTBurçin Özyürek, Master of Science
CONTACTZeynep Hoşbay, professor
Outcome results
None listed