Exercise and Vagus Nerve Stimulation in IBS

Bahçeşehir University

Status: Completed

Conditions: Irritable Bowel Syndrome (IBS)

Treatments: Behavioral: Aerobic Exercise Therapy; Behavioral: Low FODMAP Diet Intervention; Device: Auricular Vagus Nerve Stimulation (aVNS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06769516

BAU-FTR-HD-01

Details and patient eligibility

About

The aim of the study was to consider the possible role of exercise and vagus nerve on bowel functionality in chronic IBS and to demonstrate that exercise and transcutaneous auricular stimulation of the vagus nerve can reduce these symptoms in the treatment of these patients.

Full description

The study will consist of people living in the Manchester region who are diagnosed with chronic IBS and who want to volunteer for the study. Informed consent forms will be signed by all volunteers and these forms will be kept in the file. The number of people who will participate in the study was determined using G Power analysis and the number of samples was calculated as 1st group 30 people, 2nd group 30 people and 3rd group 30 people, totalling 90 people. Individuals with IBS were randomly divided into three groups and diet only [low FODMAP diet (fermentable oligo-di-mono-saccharides and polyols)], diet + aerobic exercise and diet + vagustim will be applied.

1. st group: The specified diet will be applied for 4 weeks.
2. nd group: Aerobic exercise will be applied 3 days a week (every other day) with the diet programme determined for 4 weeks.
3. rd group: Vagustim will be applied 3 days a week (every other day) with the diet programme determined for 4 weeks.

The low FODMAP (fermentable oligo-di-mono-saccharides and polyols) diet to be applied for the nutrition of the participants will be given to each individual as training before the study. In our study, vagus nerve stimulation will be applied through the ear. Aerobic exercises will be demonstrated one-to-one and the application of the patients will be monitored and the vagustim device will be applied to the groups in the clinic. In the intervention group, the vagustim device consisting of earphones placed in the outer ear, which can be selected as S, M, L according to the size of the individual's ear, and a tens device connected to the earphones will be used. The earphones will be placed to hit the tragus and concha and the device will be applied for 30 minutes with a pulse duration of less than 500 microseconds, frequency of 10 Hz and modulated TENS mode, and the current intensity will be adjusted according to the sensory threshold of the individual.

The group given aerobic exercise will be given walking exercise for 4 weeks, 3 days a week, for at least 30 minutes and at a moderate intensity not exceeding 50-70% of the maximal heart rate (if the pulse cannot be counted during sports, the criterion is that the person can talk comfortably). In our study, the decision of aerobic exercise to be given to a group was made by reviewing the literature.

Heart rate variability of the participants before and after the study will be evaluated with Polar H10 HR heart rate sensor. The bowel sounds of the participants before and after the study will be measured using a Littmann 4100 model electronic stethoscope. The first and last measurements will be measured according to the same standards and these standards are as follows: The measurements will be performed 2 hours after the last meal of the person who has not smoked for the last 2 hours before the measurements and has not consumed alcohol (permitted amount) in the last 12 hours. At the same time, 'Sociodemographic Form', 'SF-36', 'International Physical Activity Questionnaire Short Last 7 Days Self-Administered Form', 'Bristol Stool Form Scale (BSFS)' and 'Irritable Bowel Syndrome- Symptom Severity Scale (IBS-SSS)' scales will be applied to the individuals.

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• IBS for more than 1 year
• Patients with persistent IBS symptoms despite standard conventional treatments
• To be between the ages of 18-65
• Being suitable for exercise
• To be willing and voluntary to participate in the thesis study

Exclusion criteria

• People with inflammatory diseases
• Uncooperative patients
• Participants do not want to continue working
• Failure to sign the informed consent form
• History of additional chronic diseases that may prevent physical activity
• Pregnancy
• Long-term use of analgesics for more than 3 months
• Acute infection in the auricular region

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

1st Group: Low FODMAP Diet Only

Experimental group

Description:

Participants in this group will follow a Low FODMAP diet for a period of 4 weeks. The Low FODMAP diet is designed to reduce the intake of fermentable oligosaccharides, disaccharides, monosaccharides, and polyols-types of carbohydrates that are known to cause digestive issues in individuals with IBS. Prior to the start of the study, each participant will receive training on the diet and will be instructed on which foods to avoid and which to include. The goal is to assess the effect of the diet alone on the participants' IBS symptoms, including their bowel function and overall digestive health.

Treatment:

Behavioral: Low FODMAP Diet Intervention

2nd Group: Low FODMAP Diet + Aerobic Exercise

Experimental group

Description:

Participants in this group will follow a Low FODMAP diet combined with an aerobic exercise regimen for a duration of 4 weeks. The Low FODMAP diet aims to reduce the intake of fermentable carbohydrates that may trigger IBS symptoms. Along with the dietary intervention, participants will engage in moderate-intensity aerobic exercise, such as walking, three times per week for at least 30 minutes per session. The intensity will be set to 50-70% of their maximum heart rate, and participants will be encouraged to exercise at a level where they can comfortably talk while moving. The goal is to evaluate the combined effect of dietary modification and regular exercise on IBS symptoms, bowel function, and overall health.

Treatment:

Behavioral: Low FODMAP Diet Intervention

Behavioral: Aerobic Exercise Therapy

3rd Group: Low FODMAP Diet + Vagus Nerve Stimulation (Vagustim)

Experimental group

Description:

Participants in this group will follow a Low FODMAP diet combined with vagus nerve stimulation (Vagustim) for 4 weeks. The Low FODMAP diet is designed to reduce the intake of fermentable carbohydrates, which are known to trigger IBS symptoms. In addition to the dietary intervention, participants will receive vagus nerve stimulation via an ear-based device (Vagustim), applied three times a week. This device will be used for 30-minute sessions, with settings tailored to each participant's sensory threshold. Vagus nerve stimulation is believed to positively influence the autonomic nervous system and may improve IBS symptoms by reducing inflammation and modulating gut-brain signaling. The combined effect of diet and vagus nerve stimulation will be assessed to evaluate their impact on IBS symptoms, bowel function, and overall wellbeing.

Treatment:

Device: Auricular Vagus Nerve Stimulation (aVNS)

Behavioral: Low FODMAP Diet Intervention