Yogic Breathing and IBS

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

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.

Study Overview

• Status: Completed
• Conditions: IBS - Irritable Bowel Syndrome
• Intervention / Treatment: Behavioral: Yogic breathing intervention

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Marcos, Texas, United States, 78666
      • Stacy Hunter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yogic breathing intervention; 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; 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.
No Intervention: Control; 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?

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

Collaborators and Investigators

• Sponsor: Texas State University
• Investigators: Principal Investigator: Stacy D Hunter, PhD, Texas State University

Publications and helpful links

General Publications

• Katherine Jurek M, Seavey H, Guidry M, Slomka E, Hunter SD. The effects of slow deep breathing on microvascular and autonomic function and symptoms in adults with irritable bowel syndrome: A pilot study. Neurogastroenterol Motil. 2022 May;34(5):e14275. doi: 10.1111/nmo.14275. Epub 2021 Oct 1.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 9, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): August 6, 2021
• Last Update Submitted That Met QC Criteria: July 31, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome
• Other Study ID Numbers: 6275

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No