Effects of Aerobic Exercise and Pain Neuroscience Education in Irritable Bowel Syndrome

Официальное название

The Effect of Pain Neuroscience Education Added to Aerobic Exercise on Pain, Symptom Severity, and Cortisol Levels in Patients With Irritable Bowel Syndrome

Обзор

Irritable Bowel Syndrome (IBS) is a chronic disorder of gut-brain interaction characterized by abdominal pain and changes in bowel habits. The aim of this study is to compare the effects of moderate-intensity aerobic exercise alone and aerobic exercise combined with Pain Neuroscience Education on abdominal pain, IBS symptom severity, quality of life, and salivary cortisol levels in individuals with IBS. Participants will be randomly allocated into three groups: (1) Aerobic Exercise Group, (2) Aerobic Exercise plus Pain Neuroscience Education Group, and (3) Control Group. The aerobic exercise program will consist of supervised walking sessions performed twice weekly for six weeks. Pain Neuroscience Education will be delivered in short, structured sessions over the same six-week period. Assessments will be conducted at baseline and at the end of the intervention. Primary outcomes include abdominal pain intensity, IBS symptom severity, and salivary cortisol levels. Secondary outcomes include quality of life, stool form, and pain-related psychosocial measures. This study aims to provide evidence for non-pharmacological, biopsychosocial approaches in the management of IBS.

Подробное описание

This is a single-center, randomized controlled interventional study designed to investigate the added effects of Pain Neuroscience Education (PNE) to aerobic exercise on abdominal pain, symptom severity, and stress-related biological responses in individuals with Irritable Bowel Syndrome (IBS).

IBS is a multifactorial disorder of gut-brain interaction characterized by visceral hypersensitivity, central sensitization, and dysregulation of stress-response systems, particularly the hypothalamic-pituitary-adrenal (HPA) axis. Given the heterogeneous nature of IBS and the limited long-term effectiveness of pharmacological treatments, there is increasing interest in non-pharmacological, biopsychosocial approaches that target both physiological and cognitive-behavioral mechanisms.

Aerobic exercise has been shown to modulate autonomic nervous system activity, inflammatory processes, and stress regulation, which are relevant to IBS symptom expression. Pain Neuroscience Education is a structured educational intervention aimed at reducing perceived threat associated with pain by improving understanding of pain neurophysiology, addressing central sensitization mechanisms, and modifying maladaptive beliefs and avoidance behaviors. The integration of aerobic exercise with PNE is hypothesized to produce more comprehensive and sustainable clinical benefits than exercise alone by simultaneously targeting peripheral, central, and cognitive components of pain.

Adults aged 18-65 years diagnosed with IBS according to Rome IV criteria will be recruited. Participants will be stratified by IBS subtype and sex before being randomly allocated into three study groups.

The aerobic exercise intervention will consist of supervised walking sessions conducted in accordance with the American College of Sports Medicine (ACSM) guidelines. Exercise intensity will be prescribed using the Karvonen heart rate reserve method, targeting 40-59% of heart rate reserve, with progression based on individual tolerance over the six-week intervention period.

Participants allocated to the combined intervention group will receive the same aerobic exercise program along with structured PNE sessions delivered throughout the same six-week period. Educational content will focus on pain neurophysiology, central sensitization, stress responses, safety signaling, pain neuromatrix concepts, and practical coping strategies applicable to daily life.

Participants in the control group will not receive therapeutic exercise or face-to-face education. Instead, they will be provided with standard written information regarding IBS, general pain management principles, and basic recommendations for aerobic physical activity.

This study aims to contribute evidence regarding the role of integrated exercise-based and educational interventions in addressing both clinical symptoms and stress-related mechanisms in the management of IBS.

Вмешательства

• Поведенческое Exercise
  Participants will participate in a supervised aerobic exercise program designed according to the American College of Sports Medicine (ACSM) guidelines. The exercise protocol consists of treadmill walking performed three times per week for a total duration of six weeks. Each exercise session includes a 5-minute warm-up, 30 minutes of continuous aerobic exercise, and a 5-minute cool-down period. Exercise intensity is individually prescribed at 40-60% of heart rate reserve using the Karvonen formu
• Поведенческое Pain Neuroscience Education
  Pain Neuroscience Education is a structured educational intervention aimed at improving participants' understanding of the neurophysiological mechanisms underlying pain. The education focuses on central sensitization, pain modulation, and the role of the nervous system in chronic pain conditions. Educational sessions are delivered by a physiotherapist using standardized verbal explanations and visual educational materials. The content is designed to reduce maladaptive pain beliefs, promote adap

Первичные конечные точки

• Abdominal Pain Intensity (Numeric Pain Rating Scale) [Срок оценки: Baseline and at the end of the 6-week intervention period]
• IBS Symptom Severity (Irritable Bowel Syndrome Symptom Severity Score) [Срок оценки: Baseline and at the end of the 6-week intervention period]
• Salivary Cortisol Level [Срок оценки: Baseline and at the end of the 6-week intervention period]

Вторичные конечные точки (6)

• IBS-Related Quality of Life (Irritable Bowel Syndrome Quality of Life Questionnaire) [Срок оценки: Baseline and at the end of the 6-week intervention period]
• Stool Form (Bristol Stool Form Scale) [Срок оценки: Daily during the 6-week intervention period]
• Pain Catastrophizing (Pain Catastrophizing Scale) [Срок оценки: Baseline and at the end of the 6-week intervention period]
• Pain Beliefs (Pain Beliefs Scale) [Срок оценки: Baseline and at the end of the 6-week intervention period]
• Pain Knowledge (Revised Neurophysiology of Pain Questionnaire) [Срок оценки: Baseline and at the end of the 6-week intervention period]
• Physical Activity Level (International Physical Activity Questionnaire - Short Form) [Срок оценки: Baseline and at the end of the 6-week intervention period]

Критерии участия

Критерии включения

• Adults aged between 18 and 65 years
• Diagnosis of Irritable Bowel Syndrome according to Rome IV criteria
• Presence of abdominal pain for at least the past 3 months
• Ability to understand and follow study instructions
• Willingness to participate in the exercise and education sessions
• Provision of written informed consent

Критерии исключения

• Presence of organic gastrointestinal diseases (e.g., inflammatory bowel disease, celiac disease)
• History of gastrointestinal surgery affecting bowel function
• Severe cardiovascular, neurological, or musculoskeletal conditions contraindicating aerobic exercise
• Current participation in a structured exercise program
• Use of medications that may significantly affect gastrointestinal motility or pain perception
• Pregnancy
• Cognitive impairment as indicated by Mini-Mental State Examination score below the cutoff value
• Any medical condition deemed by the investigators to interfere with safe participation in the study

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

• Istinye University — Istanbul

Идентификаторы

NCT: NCT07397533 · IstinyeU-FTR-AD-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗