Clinical trial NCT06769516: Exercise and Vagus Nerve Stimulation in IBS
Official title: The Effect of Exercise and Vagus Nerve Stimulation on the Intestines in Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome (IBS)
Keywords: Irritable Bowel Syndrome
Vagus Nerve Stimulation
Exercise Therapy
Diet, Low FODMAP
Heart Rate Variability
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study utilizes a parallel assignment model, where participants are randomly assigned to one of three independent groups:

Group 1: Low FODMAP diet only. Group 2: Low FODMAP diet combined with aerobic exercise. Group 3: Low FODMAP diet combined with vagus nerve stimulation using the VagusStim device.

Each group undergoes its assigned intervention for a duration of 4 weeks. There is no crossover between groups, and all participants are evaluated separately based on their respective intervention outcomes.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in IBS Symptom Severity as Measured by IBS-SSS
timeFrame: Pre- and post-intervention (after 4 weeks of Low FODMAP diet only, Low FODMAP diet + aerobic exercise, or Low FODMAP diet + vagus nerve stimulation). IBS-Symptom Severity Scale (IBS-SSS) will be administered at baseline and after 4 weeks.
Secondary outcomes:
measure: Heart Rate Variability (HRV)
timeFrame: Pre- and post-intervention (after 4 weeks).
measure: Bowel Sounds
timeFrame: Pre- and post-intervention (after 4 weeks).
measure: Quality of Life (SF-36)
timeFrame: Pre- and post-intervention (after 4 weeks).
measure: Physical Activity Levels (IPAQ)
timeFrame: Pre- and post-intervention (after 4 weeks).
Other outcomes:
Locations:
city: Preston
country: United Kingdom
facility: Astoria Care
state: Lancashire
Study officials:
References: