Aerobic Exercise and Guided Imagery in Low Anterior Resection Syndrome

Официальное название

"The Effects of Aerobic Exercise and Guided Imagery on Low Anterior Resection Syndrome After Rectal Cancer Surgery: A Randomized Controlled Study"

Обзор

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.

Вмешательства

• Другое Exercise
  structured walking exercise, at the clinic and outside from the clinic for at least 3 days /week
• Поведенческое guided imagery
  guided imagery for at least 3 days

Первичные конечные точки

• Low Anterior Resection Sydrome scoring system [Срок оценки: "From enrollment to the end of treatment at 8 weeks"]
• European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire-30 [Срок оценки: 8 weeks from beginning the study]
• European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire-29 [Срок оценки: 8 weeks]
• 6 minutes walking test [Срок оценки: 8 weeks]

Вторичные конечные точки (5)

• colorectoanal distress inventory [Срок оценки: 8 weeks]
• wexner questionnaire [Срок оценки: 8 weeks]
• International Physical Activity Questionnaire-short form [Срок оценки: 8 weeks]
• Hospital Anxiety and Depression Scale [Срок оценки: 8 weeks]
• pelvic floor muscle function via biofeedback [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Memorial Bahçelievler Hospital — Istanbul

Идентификаторы

NCT: NCT07732894 · Biruni.

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗