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OpenTrials
Completed

NCT Number: NCT04225104

Yogic Breathing and 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.

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Key information

Conditions

IBS - Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stacy Hunter

San Marcos, Texas, 78666, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yogic breathing intervention

Behavioral

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 outcomes

  1. IBS Symptoms

    Time frame: Once at baseline

    IBS-Symptom Severity Scale will be administered.

  2. IBS Symptoms

    Time frame: Once at the end of week 2

    IBS-Symptom Severity Scale will be administered.

  3. IBS Symptoms

    Time frame: Once at the end of week 4

    IBS-Symptom Severity Scale will be administered.

  4. Autonomic function

    Time frame: Once at baseline

    Heart rate variability will be assessed.

  5. Autonomic function

    Time frame: Once at the end of week 2

    Heart rate variability will be assessed.

  6. Autonomic function

    Time frame: Once at the end of week 4

    Heart rate variability will be assessed.

  7. Autonomic function

    Time frame: Once at baseline

    Exercise heart rate recovery will be measured.

  8. Autonomic function

    Time frame: Once at the end of week 2

    Exercise heart rate recovery will be measured.

  9. Autonomic function

    Time frame: Once at the end of week 4

    Exercise heart rate recovery will be measured.

  10. Microvascular function

    Time frame: Once at baseline

    Laser Doppler flowmetry at baseline and in response to local heating will be measured.

  11. Microvascular function

    Time frame: Once at the end of week 4

    Laser Doppler flowmetry and in response to local heating will be measured.

Sponsors and collaborators

Lead sponsor

Texas State University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 13, 2020
Registry last updated
Aug 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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