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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Behavioral: Iyengar yoga

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90064
      • UCLA Pediatric Pain Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 26 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Waitlist control
EXPERIMENTAL: Iyengar yoga	Behavioral: Iyengar yoga; Iyengar yoga twice/week for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Subhadra Evans, Ph.D., University of California, Los Angeles

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: April 20, 2010
• First Submitted That Met QC Criteria: April 20, 2010
• First Posted (ESTIMATE): April 21, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): November 28, 2016
• Last Update Submitted That Met QC Criteria: November 23, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: 1K01AT005093 (NIH)