Iyengar Yoga for Young People With Irritable Bowel Syndrome

NCT01107977 | Completed DMC

• 1 other identifier: 1K01AT005093
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (6)

• Irritable bowel symptoms

  baseline (within 2 weeks of receiving intervention)

• Irritable bowel symptoms

  post-intervention (within 2 weeks of completing intervention)

• Irritable bowel symptoms

  follow up (2 months after completion of intervention)

• Quality of Life

  baseline (within 2 weeks of receiving intervention)

• Quality of Life

  post-intervention (within 2 weeks of completing intervention)

• Quality of Life

  follow up (2 months after completion of intervention)

Study Arms (2)

Iyengar yoga

EXPERIMENTAL

Behavioral: Iyengar yoga

Waitlist control

NO INTERVENTION

Interventions

Iyengar yoga BEHAVIORAL

Iyengar yoga twice/week for 6 weeks

Iyengar yoga

Eligibility Criteria

• Age: 14 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Pediatric Pain Program

Los Angeles, California, 90064, United States

Location

Related Publications (2)

• 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.

  PMID: 25025601 RESULT

• 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.

  PMID: 21244698 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Subhadra Evans, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2010
• First Posted: April 21, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 28, 2016

Record last verified: 2016-11

Locations

US (1)