NCT04225104

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

August 6, 2021

Status Verified

March 1, 2021

Enrollment Period

10 months

First QC Date

January 7, 2020

Last Update Submit

July 31, 2021

Conditions

IBS - Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (11)

  • 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

Study Arms (2)

Yogic breathing intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Yogic breathing interventionBEHAVIORAL

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.

Yogic breathing intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must have a formal diagnosis of IBS and not be enrolled in any other clinical trials.

You may not qualify if:

  • \) current, regular practice of yogic breathing at least 5 minutes per day and 2) chronic obstructive pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stacy Hunter

San Marcos, Texas, 78666, United States

Location

Related Publications (1)

  • 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.

    PMID: 34595801DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Stacy D Hunter, PhD

    Texas State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Members of the investigative team will be blinded to the participant's group assignment until all testing is completed.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2020

First Posted

January 13, 2020

Study Start

April 15, 2019

Primary Completion

February 1, 2020

Study Completion

March 1, 2020

Last Updated

August 6, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)