Iyengar Yoga for Young People With Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:

Iyengar Yoga for Young People With Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01107977
• Other study ID #: 1K01AT005093
• Status: Completed
• Phase: N/A
• First received: April 20, 2010
• Last updated: November 23, 2016
• Start date: January 2010
• Est. completion date: December 2013

Study information

• Verified date: November 2016
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 26 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Behavioral:
• Iyengar yoga
Iyengar yoga twice/week for 6 weeks

Locations

Country	Name	City	State
United States	UCLA Pediatric Pain Program	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Irritable bowel symptoms		baseline (within 2 weeks of receiving intervention)	No
Primary	Irritable bowel symptoms		post-intervention (within 2 weeks of completing intervention)	No
Primary	Irritable bowel symptoms		follow up (2 months after completion of intervention)	No
Primary	Quality of Life		baseline (within 2 weeks of receiving intervention)	No
Primary	Quality of Life		post-intervention (within 2 weeks of completing intervention)	No
Primary	Quality of Life		follow up (2 months after completion of intervention)	No