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

NCT07397533 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-09
Last updated
2026-02-11

Condition(s) studied

Irritable Bowel Syndrome

Investigational drug(s) / intervention(s)

ExercisePain Neuroscience Education

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 formula. Heart rate is monitored throughout the sessions to ensure adherence to the target intensity range. All sessions are supervised by a physiotherapist, and exercise progression is adjusted based on participant tolerance and safety considerations.

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 adaptive pain coping strategies, and enhance pain-related knowledge. Sessions are conducted regularly throughout the intervention period and are tailored to the participants' comprehension levels while maintaining standardized core educational content.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • Abdominal Pain Intensity (Numeric Pain Rating Scale) — Baseline and at the end of the 6-week intervention period
    Abdominal pain intensity is assessed using the Numeric Pain Rating Scale, where participants rate their average abdominal pain intensity over the previous week on an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
  • IBS Symptom Severity (Irritable Bowel Syndrome Symptom Severity Score) — Baseline and at the end of the 6-week intervention period
    IBS symptom severity will be assessed using the Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS). This validated questionnaire consists of five items evaluating abdominal pain severity, abdominal pain frequency, abdominal bloating, dissatisfaction with bowel habits, and interference of IBS symptoms with daily life. Each item is scored from 0 to 100, resulting in a total score ranging from 0 to 500. Higher total scores indicate greater IBS symptom severity. Symptom severity is commonly categorized as: 75-174: Mild IBS 175-299: Moderate IBS ≥300: Severe IBS
  • Salivary Cortisol Level — Baseline and at the end of the 6-week intervention period
    Salivary cortisol levels are measured as a biomarker of physiological stress response. Saliva samples are collected using standardized procedures and analyzed using enzyme-linked immunosorbent assay methods. Cortisol concentrations are normalized to total protein concentration.

Trial sites (1)

FacilityCityRegionStatus
Istinye University Istanbul Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07397533 on ClinicalTrials.gov ↗ ← All trials in Turkey