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

Istinye University

Status: Begins enrollment in 4 months

Conditions: Irritable Bowel Syndrome

Treatments: Behavioral: Pain Neuroscience Education; Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT07397533

IstinyeU-FTR-AD-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 33 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 3 patient groups

Aerobic Exercise Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Exercise

Aerobic Exercise plus Pain Neuroscience Education Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Exercise

Behavioral: Pain Neuroscience Education

Control Group

No Intervention group

Description:

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.