Yogic Breathing and IBS

Sponsor

Texas State University (Other)

Overall Status

Completed

CT.gov ID

NCT04225104

Collaborator

(none)

Enrollment

Location

Arms

10.5

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
IBS - Irritable Bowel Syndrome	Behavioral: Yogic breathing intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Masking Description:

Members of the investigative team will be blinded to the participant's group assignment until all testing is completed.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 15, 2019

Actual Primary Completion Date :

Feb 1, 2020

Actual Study Completion Date :

Mar 1, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stacy Hunter	San Marcos	Texas	United States	78666

Sponsors and Collaborators

Texas State University

Investigators

Principal Investigator: Stacy D Hunter, PhD, Texas State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Texas State University

ClinicalTrials.gov Identifier:

NCT04225104

Other Study ID Numbers:

6275

First Posted:

Jan 13, 2020

Last Update Posted:

Aug 6, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Irritable Bowel Syndrome

Study Results

No Results Posted as of Aug 6, 2021