Aerobic Exercise and Guided Imagery in Low Anterior Resection Syndrome

NCT07732894 | Recruiting

• 1 other identifier: Biruni.
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer; Fecal Incontinence and Constipation; Aerobic Exercise; Guided Imagery Exercise; Pelvic Floor Physical Therapy; Pelvic Floor Muscle Training

Keywords

rectal cancer; low anterior resection syndrome; aerobic exercise; guided imagery; pelvic floor muscle training; pelvic floor rehabilitation; pelvic floor physical therapy

Outcome Measures

Primary Outcomes (4)

• 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.

  "From enrollment to the end of treatment at 8 weeks"

• 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.

  8 weeks from beginning the study

• 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.

  8 weeks

• 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.

  8 weeks

Secondary Outcomes (5)

• 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

Study Arms (2)

aerobic exercise and guided imagery group in addition to standart care

EXPERIMENTAL

Participants will receive an aerobic exercise program combined with guided imagery in addition to standard postoperative care. The intervention will be delivered according to the study protocol throughout the intervention period.

Other: Exercise; Behavioral: guided imagery

standart care group

NO INTERVENTION

Participants will receive standard postoperative care without the structured aerobic exercise or guided imagery during the study period.

Interventions

Exercise OTHER

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

Also known as: aerobic exercise

aerobic exercise and guided imagery group in addition to standart care

guided imagery BEHAVIORAL

guided imagery for at least 3 days

aerobic exercise and guided imagery group in addition to standart care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Memorial Bahçelievler Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms; Fecal Incontinence; Constipation; Low Anterior Resection Syndrome

Interventions

Exercise; Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Colonic Diseases; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Burçin Özyürek, Master of Science

CONTACT

+905367149912; burcinozyurek@gmail.com

Zeynep Hoşbay, professor

CONTACT

zhosbay@biruni.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 29, 2026
• Study Start: December 30, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

TU (1)