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

NCT07397533 | Not Yet Recruiting

• 1 other identifier: IstinyeU-FTR-AD-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome; Aerobic Exercise; Abdominal Pain; Cortisol

Outcome Measures

Primary Outcomes (3)

• Abdominal Pain Intensity (Numeric Pain Rating Scale)

  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.

  Baseline and at the end of the 6-week intervention period

• IBS Symptom Severity (Irritable Bowel Syndrome Symptom Severity Score)

  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

  Baseline and at the end of the 6-week intervention period

• Salivary Cortisol Level

  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.

  Baseline and at the end of the 6-week intervention period

Secondary Outcomes (6)

• IBS-Related Quality of Life (Irritable Bowel Syndrome Quality of Life Questionnaire)

  Baseline and at the end of the 6-week intervention period

• Stool Form (Bristol Stool Form Scale)

  Daily during the 6-week intervention period

• Pain Catastrophizing (Pain Catastrophizing Scale)

  Baseline and at the end of the 6-week intervention period

• Pain Beliefs (Pain Beliefs Scale)

  Baseline and at the end of the 6-week intervention period

• Pain Knowledge (Revised Neurophysiology of Pain Questionnaire)

  Baseline and at the end of the 6-week intervention period

Study Arms (3)

Aerobic Exercise Group

ACTIVE COMPARATOR

Participants in this group will receive a supervised moderate-intensity aerobic exercise program designed according to the American College of Sports Medicine (ACSM) guidelines. The program will consist of treadmill-based walking sessions performed twice weekly for six weeks. Exercise intensity will be set at 40-59% of Heart Rate Reserve using the Karvonen method, and session duration will be progressively increased.

Behavioral: Exercise

Aerobic Exercise plus Pain Neuroscience Education Group

ACTIVE COMPARATOR

Participants in this group will receive the same aerobic exercise program as the Aerobic Exercise Group. In addition, structured Pain Neuroscience Education sessions will be delivered over a six-week period. The education will address pain neurophysiology, central sensitization, stress responses, safety cues, and cognitive-behavioral strategies aimed at reducing perceived threat related to pain and enhancing engagement in physical activity.

Behavioral: Exercise; Behavioral: Pain Neuroscience Education

Control Group

NO INTERVENTION

Participants in the control group receive standard care and are provided with an informational brochure containing general information related to the condition. No structured exercise program or educational intervention is delivered during the study period.

Interventions

Exercise BEHAVIORAL

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.

Aerobic Exercise Group; Aerobic Exercise plus Pain Neuroscience Education Group

Pain Neuroscience Education BEHAVIORAL

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.

Aerobic Exercise plus Pain Neuroscience Education Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Istinye University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Abdominal Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Azize Dik

CONTACT

+90 5438504331; 229914296@stu.istinye.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is designed as a parallel-group interventional trial. Participants are allocated to intervention groups and followed concurrently throughout the study period without crossover between groups.

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 11, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)