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Iyengar Yoga for Young People With Irritable Bowel Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lonnie Zeltzer, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01107977
First received: April 20, 2010
Last updated: April 25, 2016
Last verified: April 2016

April 20, 2010
April 25, 2016
January 2010
December 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01107977 on ClinicalTrials.gov Archive Site
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Iyengar Yoga for Young People With Irritable Bowel Syndrome
Iyengar Yoga for Young People With Irritable Bowel Syndrome
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.
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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Irritable Bowel Syndrome
Behavioral: Iyengar yoga
Iyengar yoga twice/week for 6 weeks
  • Experimental: Iyengar yoga
    Intervention: Behavioral: Iyengar yoga
  • No Intervention: Waitlist control
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
14 Years to 26 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01107977
1K01AT005093
Yes
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Lonnie Zeltzer, University of California, Los Angeles
University of California, Los Angeles
Not Provided
Principal Investigator: Subhadra Evans, Ph.D. University of California, Los Angeles
University of California, Los Angeles
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP