NCT06769516

Exercise and Vagus Nerve Stimulation in IBS

The Effect of Exercise and Vagus Nerve Stimulation on the Intestines in Irritable Bowel Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Bahçeşehir University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Irritable Bowel Syndrome (IBS)

Interventions

Type	Name	Description
DEVICE	Auricular Vagus Nerve Stimulation (aVNS)	This intervention involves transcutaneous auricular vagus nerve stimulation (taVNS) using the VagusStim device. The device consists of earphones tailored to fit the individual's ear size (S, M, L) and is connected to a TENS unit. The stimulation is applied to the tragus and concha of the ear for 30 minutes, three times a week, over a 4-week period. The device operates with a pulse duration of less than 500 microseconds, a frequency of 10 Hz, and in a modulated TENS mode. The current intensity is individually adjusted to the participant's sensory threshold. This method targets the vagus nerve to potentially regulate autonomic activity and improve symptoms of Irritable Bowel Syndrome (IBS). The study combines this intervention with a low FODMAP diet for all participants, distinguishing it from studies focused solely on vagus nerve stimulation or dietary changes.
BEHAVIORAL	Aerobic Exercise Therapy	This intervention involves a structured aerobic exercise program designed to improve physical activity levels and modulate symptoms of Irritable Bowel Syndrome (IBS). Participants engage in walking exercises at a moderate intensity, maintaining 50-70% of their maximum heart rate, ensuring the ability to converse comfortably during the activity. The exercise sessions last for at least 30 minutes, three days a week, on alternate days, over a 4-week period. Participants are individually trained and monitored to ensure proper technique and adherence to the exercise protocol. The intervention is combined with a low FODMAP diet, providing a multimodal approach to IBS symptom management. This distinguishes it from other interventions by emphasizing physical activity's role in enhancing gastrointestinal and overall health.
BEHAVIORAL	Low FODMAP Diet Intervention	This intervention involves the implementation of a low FODMAP (fermentable oligo-, di-, mono-saccharides, and polyols) diet to manage symptoms of Irritable Bowel Syndrome (IBS). Participants receive individualized training on the diet before the study begins. The diet eliminates high FODMAP foods known to exacerbate IBS symptoms, such as certain fruits, vegetables, dairy products, and sweeteners, for a duration of 4 weeks. Participants follow the prescribed dietary protocol under guidance, ensuring adherence and addressing specific nutritional needs. This intervention aims to reduce gastrointestinal distress by limiting fermentable carbohydrates, distinguishing it from other IBS management strategies that do not focus on dietary modifications.

Timeline

• Start date: 2024-06-01
• Primary completion: 2024-11-01
• Completion: 2025-01-01
• First posted: 2025-01-10
• Last updated: 2025-01-10

Locations

1 site across 1 country: United Kingdom