Exercise and Vagus Nerve Stimulation in IBS

NCT06769516 | Completed

• 1 other identifier: BAU-FTR-HD-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome (IBS)

Keywords

Irritable Bowel Syndrome; Vagus Nerve Stimulation; Exercise Therapy; Diet, Low FODMAP; Heart Rate Variability

Outcome Measures

Primary Outcomes (1)

• Change in IBS Symptom Severity as Measured by IBS-SSS

  The primary outcome measure of this study is the change in IBS symptoms, assessed using the IBS-Symptom Severity Scale (IBS-SSS). This scale evaluates the severity of key symptoms of irritable bowel syndrome, including abdominal pain, bloating, and the frequency and severity of bowel movements. Participants will complete the IBS-SSS questionnaire before and after the 4-week intervention period, which includes the low FODMAP diet, aerobic exercise, or vagus nerve stimulation (Vagustim). The change in the IBS-SSS score will be used to assess the impact of the interventions on symptom severity and provide insight into the efficacy of each treatment approach.

  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 (4)

• Heart Rate Variability (HRV)

  Pre- and post-intervention (after 4 weeks).

• Bowel Sounds

  Pre- and post-intervention (after 4 weeks).

• Quality of Life (SF-36)

  Pre- and post-intervention (after 4 weeks).

• Physical Activity Levels (IPAQ)

  Pre- and post-intervention (after 4 weeks).

Study Arms (3)

1st Group: Low FODMAP Diet Only

EXPERIMENTAL

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.

Behavioral: Low FODMAP Diet Intervention

2nd Group: Low FODMAP Diet + Aerobic Exercise

EXPERIMENTAL

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.

Behavioral: Aerobic Exercise Therapy; Behavioral: Low FODMAP Diet Intervention

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

EXPERIMENTAL

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.

Device: Auricular Vagus Nerve Stimulation (aVNS); Behavioral: Low FODMAP Diet Intervention

Interventions

Auricular Vagus Nerve Stimulation (aVNS) DEVICE

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.

Also known as: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), VagusStim Device Therapy, Electrical Stimulation of Auricular Vagus Nerve, TENS-Based Auricular Stimulation

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

Aerobic Exercise Therapy BEHAVIORAL

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.

Also known as: Moderate-Intensity Walking Program, Aerobic Physical Activity Intervention, Walking Therapy for IBS

2nd Group: Low FODMAP Diet + Aerobic Exercise

Low FODMAP Diet Intervention BEHAVIORAL

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.

Also known as: Low FODMAP Nutritional Therapy, FODMAP-Restricted Diet, IBS Symptom-Targeted Diet

1st Group: Low FODMAP Diet Only; 2nd Group: Low FODMAP Diet + Aerobic Exercise; 3rd Group: Low FODMAP Diet + Vagus Nerve Stimulation (Vagustim)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Astoria Care

Preston, Lancashire, PR2 3AQ, United Kingdom

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No parties are masked in this clinical trial. All participants, care providers, investigators, and outcomes assessors are aware of the assigned interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist physiotherapist

Model Details: 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.

Study Record Dates

• First Submitted: January 1, 2025
• First Posted: January 10, 2025
• Study Start: June 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: January 1, 2025
• Last Updated: January 10, 2025

Record last verified: 2025-01

Locations

GB (1)