Iyengar Yoga for Young People With Irritable Bowel Syndrome
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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 |
- 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 |
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| Contact: Laura Cousins | 310-475 3191 | lcousins@mednet.ucla.edu |
| Contact: Subhadra Evans | 310-475 3191 | suevans@mednet.ucla.edu |
| 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. | |
| 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 May 21, 2013