Aerobic Exercise and Guided Imagery in Low Anterior Resection Syndrome

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBiruni University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Exercise

    Other intervention

    structured walking exercise, at the clinic and outside from the clinic for at least 3 days /week

  • guided imagery

    Behavioral

    guided imagery for at least 3 days

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: aerobic exercise and guided imagery group in addition to standart careExperimental treatment 2 interventions
Group B: standart care groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
"From enrollment to the end of treatment at 8 weeks"
2

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.

Time frame
8 weeks from beginning the study
3

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.

Time frame
8 weeks
4

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.

Time frame
8 weeks

Secondary outcomes

1

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.

Time frame
8 weeks
2

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.

Time frame
8 weeks
3

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.

Time frame
8 weeks
4

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.

Time frame
8 weeks

Other outcomes

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