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Completed

NCT Number: NCT01107977

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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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

14 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Pediatric Pain Program

Los Angeles, California, 90064, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iyengar Yoga

Behavioral

Iyengar yoga twice/week for 6 weeks

Primary outcomes

  1. Irritable bowel symptoms

    Time frame: baseline (within 2 weeks of receiving intervention)

  2. Irritable bowel symptoms

    Time frame: post-intervention (within 2 weeks of completing intervention)

  3. Irritable bowel symptoms

    Time frame: follow up (2 months after completion of intervention)

  4. Quality of Life

    Time frame: baseline (within 2 weeks of receiving intervention)

  5. Quality of Life

    Time frame: post-intervention (within 2 weeks of completing intervention)

  6. Quality of Life

    Time frame: follow up (2 months after completion of intervention)

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Apr 21, 2010
Registry last updated
Nov 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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