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Irritable Bowel SyndromeNCT07397533

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

A study testing Exercise and Pain Neuroscience Education in people with Irritable Bowel Syndrome, run by Istinye University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Irritable Bowel Syndrome
What is being tested?
Exercise and Pain Neuroscience Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteTurkey (Türkiye)
Study dates
Sep 2026to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site
  • Istinye University

    Istanbul

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the detailed 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.

Being tested
Exercise, Pain Neuroscience Education
Keywords
Irritable Bowel Syndrome, Aerobic Exercise, Abdominal Pain, Cortisol
Medical subject headings
Irritable Bowel Syndrome, Abdominal Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseBehavioural

    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 EducationBehavioural

    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 groups in NCT07397533
Study groupRoleWhat they receive
Aerobic Exercise GroupActive comparatorParticipants 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.
Receives: Behavioral: Exercise
Aerobic Exercise plus Pain Neuroscience Education GroupActive comparatorParticipants 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.
Receives: Behavioral: Exercise; Behavioral: Pain Neuroscience Education
Control GroupNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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

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

  3. 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.

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

Secondary outcomes (6)
  1. IBS-Related Quality of Life (Irritable Bowel Syndrome Quality of Life Questionnaire)

    IBS-related quality of life will be assessed using the Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QOL), a disease-specific instrument measuring the impact of IBS on physical, emotional, and social functioning.

    The questionnaire consists of 34 items, with total raw scores ranging from 34 to 170. Raw scores will be transformed to a 0-100 scale, where higher scores indicate better quality of life.

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

  2. Stool Form (Bristol Stool Form Scale)

    Stool form will be assessed using the Bristol Stool Form Scale (BSFS), a validated visual classification system developed by Heaton et al. The scale categorizes stool consistency into seven distinct types.

    Scores range from 1 to 7, where:

    Types 1-2 indicate hard stools associated with constipation,

    Types 3-4 indicate normal stool form,

    Types 5-7 indicate loose or watery stools associated with diarrhea.

    Participants will record stool frequency and form daily throughout the 6-week intervention period. The scale will be used to evaluate IBS symptoms and IBS subtypes.

    Measured: Daily during the 6-week intervention period

  3. Pain Catastrophizing (Pain Catastrophizing Scale)

    Pain catastrophizing will be assessed using the Pain Catastrophizing Scale (PCS), which evaluates rumination, magnification, and helplessness related to pain experiences.

    Total scores range from 0 to 52, with higher scores indicating greater levels of pain catastrophizing.

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

  4. Pain Beliefs (Pain Beliefs Scale)

    Pain-related beliefs will be assessed using the Pain Beliefs Scale (PBS), which evaluates individuals' beliefs regarding the nature, causes, and consequences of pain. The scale consists of 12 items assessing organic and psychological pain beliefs.

    Items are rated on a 1 to 6 Likert scale. Higher subscale scores indicate stronger pain-related beliefs. No cutoff score is defined for this scale.

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

  5. Pain Knowledge (Revised Neurophysiology of Pain Questionnaire)

    Pain-related knowledge will be assessed using the Revised Neurophysiology of Pain Questionnaire (RNPQ). The questionnaire consists of 12 items assessing understanding of pain neurophysiology concepts.

    Each correct response is scored as 1, while incorrect or uncertain responses are scored as 0, resulting in a total score ranging from 0 to 12.

    Higher scores indicate greater knowledge of pain neurophysiology.

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

  6. Physical Activity Level (International Physical Activity Questionnaire - Short Form)

    Physical activity level is assessed using the International Physical Activity Questionnaire - Short Form, which evaluates walking, moderate-intensity, and vigorous-intensity physical activity over the previous 7 days. Higher scores indicate higher physical activity levels.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07397533
Sponsor's protocol ID
IstinyeU-FTR-AD-01
Status last verified
Jan 2026
First submitted
2 Feb 2026
Last updated
11 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise and Pain Neuroscience Education in people with Irritable Bowel Syndrome, run by Istinye University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Azize Dik (+90 5438504331, 229914296@stu.istinye.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Abdominal Pain Intensity (Numeric Pain Rating Scale) (time frame: Baseline and at the end of the 6-week intervention period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.

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