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Iyengar Yoga for Young People With Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Iyengar yoga
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

14 Years - 26 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female youth will be eligible for the study if they meet the following criteria:

    • Age 14-26 years.
    • Diagnosis of IBS, using ROME III pediatric criteria for patients aged 14-17 years, and ROME III adult criteria for 18-26 year-olds.
    • Able and willing to give written informed assent or consent and comply with the requirements of the study protocol.
    • Ability to speak and understand English.

Exclusion Criteria:

  • Any other injury, disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion that it might affect the interpretation of the results or render the patient at high risk from treatment complications.

    • Inability to comply with study and follow-up procedures.
    • Currently pregnant.
    • Previous practice of yoga within the past three months.
    • Inability to speak and understand English.
    • Plan to begin a new treatment within 2 weeks of the IYP.

Sites / Locations

  • UCLA Pediatric Pain Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Iyengar yoga

Waitlist control

Arm Description

Outcomes

Primary Outcome Measures

Irritable bowel symptoms
Irritable bowel symptoms
Irritable bowel symptoms
Quality of Life
Quality of Life
Quality of Life

Secondary Outcome Measures

Full Information

First Posted
April 20, 2010
Last Updated
November 23, 2016
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT01107977
Brief Title
Iyengar Yoga for Young People With Irritable Bowel Syndrome
Official Title
Iyengar Yoga for Young People With Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Irritable bowel syndrome (IBS) affects as many as 14% of high school-aged students. Symptoms include discomfort in the abdomen, along with diarrhea and/or constipation and other gastroenterological symptoms, which can significantly impact quality of life and daily functioning of patients. Emotional stress appears to exacerbate IBS symptoms suggesting that mind-body interventions reducing arousal may prove beneficial. Often symptoms can be traced to childhood and adolescence, making the early manifestation of IBS important to understand. The current study focuses on young people aged 14-26 years of age with IBS. The study will test the potential benefits of Iyengar yoga (IY) on clinical symptoms, psychospiritual functioning and visceral sensitivity. Yoga is thought to bring physical, psychological and spiritual benefits to practitioners and has been associated with reduced stress and pain. Through its focus on restoration and use of props, IY is especially designed to decrease arousal and promote psychospiritual resources in physically compromised individuals. Sixty-four IBS patients aged 14-26 will be randomly assigned to a standardized 6-week biweekly IY group-based program (1.5 hour sessions) or a wait-list usual care control group. The groups will be compared on the primary clinical outcomes of IBS symptoms, quality of life and global improvement at post-treatment and 2 month follow-up. Secondary outcomes will include visceral pain sensitivity assessed with a standardized laboratory task (water load task), and psychospiritual variables including coping, self-efficacy, mood, acceptance and mindfulness. It is hypothesized that IY will be safe and feasible: with less than 20% attrition; and the IY group will demonstrate significantly improved outcomes compared to controls, with physiological and psychospiritual mechanisms contributing to improvements; clinical treatment gains will be maintained at 2 months following yoga.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iyengar yoga
Arm Type
Experimental
Arm Title
Waitlist control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Iyengar yoga
Intervention Description
Iyengar yoga twice/week for 6 weeks
Primary Outcome Measure Information:
Title
Irritable bowel symptoms
Time Frame
baseline (within 2 weeks of receiving intervention)
Title
Irritable bowel symptoms
Time Frame
post-intervention (within 2 weeks of completing intervention)
Title
Irritable bowel symptoms
Time Frame
follow up (2 months after completion of intervention)
Title
Quality of Life
Time Frame
baseline (within 2 weeks of receiving intervention)
Title
Quality of Life
Time Frame
post-intervention (within 2 weeks of completing intervention)
Title
Quality of Life
Time Frame
follow up (2 months after completion of intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female youth will be eligible for the study if they meet the following criteria: Age 14-26 years. Diagnosis of IBS, using ROME III pediatric criteria for patients aged 14-17 years, and ROME III adult criteria for 18-26 year-olds. Able and willing to give written informed assent or consent and comply with the requirements of the study protocol. Ability to speak and understand English. Exclusion Criteria: Any other injury, disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion that it might affect the interpretation of the results or render the patient at high risk from treatment complications. Inability to comply with study and follow-up procedures. Currently pregnant. Previous practice of yoga within the past three months. Inability to speak and understand English. Plan to begin a new treatment within 2 weeks of the IYP.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Subhadra Evans, Ph.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Pediatric Pain Program
City
Los Angeles
State/Province
California
ZIP/Postal Code
90064
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25025601
Citation
Evans S, Lung KC, Seidman LC, Sternlieb B, Zeltzer LK, Tsao JC. Iyengar yoga for adolescents and young adults with irritable bowel syndrome. J Pediatr Gastroenterol Nutr. 2014 Aug;59(2):244-53. doi: 10.1097/MPG.0000000000000366.
Results Reference
result
PubMed Identifier
21244698
Citation
Evans S, Cousins L, Tsao JC, Sternlieb B, Zeltzer LK. Protocol for a randomized controlled study of Iyengar yoga for youth with irritable bowel syndrome. Trials. 2011 Jan 18;12:15. doi: 10.1186/1745-6215-12-15.
Results Reference
derived

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Iyengar Yoga for Young People With Irritable Bowel Syndrome

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