Yogic Breathing and IBS

Study Overview
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Brief Summary
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Adults with irritable bowel syndrome (IBS) are being randomized to a yogic breathing or control condition. Participants randomized to the yogic breathing group will be asked to complete a 2-minute yogic breathing video 5 to 7 days per week at home for 4 weeks and control group participants will be asked to maintain their current activities. Participants in this group will be given access to the yogic breathing video at the end of the 4-week control period. IBS symptoms and autonomic and vascular function will be assessed at baseline and at the end of week 4 in both groups.

Official Title
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Effects of Yogic Breathing on Microvascular Endothelial Function and Symptoms in Participants With IBS

Conditions
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IBS - Irritable Bowel Syndrome

Intervention / Treatment
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* Behavioral: Yogic breathing intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have a formal diagnosis of IBS and not be enrolled in any other clinical trials. Exclusion Criteria: 1) current, regular practice of yogic breathing at least 5 minutes per day and 2) chronic obstructive pulmonary disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yogic breathing intervention<br>Participants assigned to this group will complete a 20-minute yogic breathing video at least 5 days per week for 4 weeks. All sessions except the initial yogic breathing session will be completed at home. Participants will complete the first session at Texas State under the supervision of the investigative team for familiarization. | Behavioral: Yogic breathing intervention<br>* Yogic breathing will be completed while following a video provided by the investigative team. Breathing practices consist of slow, deep, relaxation breathing and are led by a certified yoga instructor.<br>|
| No Intervention: Control<br>Participants in the control group will be asked to maintain their current daily activities and will be given access to the yogic breathing video once all follow-up testing has been completed at the end of week 4. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IBS Symptoms | IBS-Symptom Severity Scale will be administered. | Once at baseline | 
| IBS Symptoms | IBS-Symptom Severity Scale will be administered. | Once at the end of week 2 | 
| IBS Symptoms | IBS-Symptom Severity Scale will be administered. | Once at the end of week 4 | 
| Autonomic function | Heart rate variability will be assessed. | Once at baseline | 
| Autonomic function | Heart rate variability will be assessed. | Once at the end of week 2 | 
| Autonomic function | Heart rate variability will be assessed. | Once at the end of week 4 | 
| Autonomic function | Exercise heart rate recovery will be measured. | Once at baseline | 
| Autonomic function | Exercise heart rate recovery will be measured. | Once at the end of week 2 | 
| Autonomic function | Exercise heart rate recovery will be measured. | Once at the end of week 4 | 
| Microvascular function | Laser Doppler flowmetry at baseline and in response to local heating will be measured. | Once at baseline | 
| Microvascular function | Laser Doppler flowmetry and in response to local heating will be measured. | Once at the end of week 4 |