Iyengar Yoga for Young People With Irritable Bowel Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01107977
First received: April 20, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Irritable Bowel Syndrome
Behavioral: Iyengar yoga

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Iyengar Yoga for Young People With Irritable Bowel Syndrome

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Irritable bowel symptoms [ Time Frame: baseline (within 2 weeks of receiving intervention) ] [ Designated as safety issue: No ]
  • Irritable bowel symptoms [ Time Frame: post-intervention (within 2 weeks of completing intervention) ] [ Designated as safety issue: No ]
  • Irritable bowel symptoms [ Time Frame: follow up (2 months after completion of intervention) ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: baseline (within 2 weeks of receiving intervention) ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: post-intervention (within 2 weeks of completing intervention) ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: follow up (2 months after completion of intervention) ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iyengar yoga Behavioral: Iyengar yoga
Iyengar yoga twice/week for 6 weeks
No Intervention: Waitlist control

  Eligibility

Ages Eligible for Study:   14 Years to 26 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01107977

Contacts
Contact: Laura Cousins 310-475 3191 lcousins@mednet.ucla.edu
Contact: Subhadra Evans 310-475 3191 suevans@mednet.ucla.edu

Locations
United States, California
UCLA Pediatric Pain Program Recruiting
Los Angeles, California, United States, 90064
Contact: Lonnie K Zeltzer, M.D.    310-825-0731    LZeltzer@mednet.ucla.edu   
Principal Investigator: Subhadra Evans, Ph.D.         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Subhadra Evans, Ph.D. University of California, Los Angeles
  More Information

No publications provided by University of California, Los Angeles

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Subhadra Evans/Assistant Research Psychologist, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01107977     History of Changes
Other Study ID Numbers: 1K01AT005093
Study First Received: April 20, 2010
Last Updated: April 20, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 01, 2014