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Yogic Breathing and IBS

Primary Purpose

IBS - Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yogic breathing intervention
Sponsored by
Texas State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IBS - Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Stacy Hunter

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Yogic breathing intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

IBS Symptoms
IBS-Symptom Severity Scale will be administered.
IBS Symptoms
IBS-Symptom Severity Scale will be administered.
IBS Symptoms
IBS-Symptom Severity Scale will be administered.
Autonomic function
Heart rate variability will be assessed.
Autonomic function
Heart rate variability will be assessed.
Autonomic function
Heart rate variability will be assessed.
Autonomic function
Exercise heart rate recovery will be measured.
Autonomic function
Exercise heart rate recovery will be measured.
Autonomic function
Exercise heart rate recovery will be measured.
Microvascular function
Laser Doppler flowmetry at baseline and in response to local heating will be measured.
Microvascular function
Laser Doppler flowmetry and in response to local heating will be measured.

Secondary Outcome Measures

Full Information

First Posted
January 7, 2020
Last Updated
July 31, 2021
Sponsor
Texas State University
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1. Study Identification

Unique Protocol Identification Number
NCT04225104
Brief Title
Yogic Breathing and IBS
Official Title
Effects of Yogic Breathing on Microvascular Endothelial Function and Symptoms in Participants With IBS
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBS - Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Members of the investigative team will be blinded to the participant's group assignment until all testing is completed.
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yogic breathing intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Yogic breathing intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
IBS Symptoms
Description
IBS-Symptom Severity Scale will be administered.
Time Frame
Once at baseline
Title
IBS Symptoms
Description
IBS-Symptom Severity Scale will be administered.
Time Frame
Once at the end of week 2
Title
IBS Symptoms
Description
IBS-Symptom Severity Scale will be administered.
Time Frame
Once at the end of week 4
Title
Autonomic function
Description
Heart rate variability will be assessed.
Time Frame
Once at baseline
Title
Autonomic function
Description
Heart rate variability will be assessed.
Time Frame
Once at the end of week 2
Title
Autonomic function
Description
Heart rate variability will be assessed.
Time Frame
Once at the end of week 4
Title
Autonomic function
Description
Exercise heart rate recovery will be measured.
Time Frame
Once at baseline
Title
Autonomic function
Description
Exercise heart rate recovery will be measured.
Time Frame
Once at the end of week 2
Title
Autonomic function
Description
Exercise heart rate recovery will be measured.
Time Frame
Once at the end of week 4
Title
Microvascular function
Description
Laser Doppler flowmetry at baseline and in response to local heating will be measured.
Time Frame
Once at baseline
Title
Microvascular function
Description
Laser Doppler flowmetry and in response to local heating will be measured.
Time Frame
Once at the end of week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacy D Hunter, PhD
Organizational Affiliation
Texas State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stacy Hunter
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34595801
Citation
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.
Results Reference
derived

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Yogic Breathing and IBS

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