Yoga for Youth With IBD: a Pilot Feasibility Study

Study Overview
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Brief Summary
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An 8-week yoga intervention to determine the feasibility and acceptability of yoga as a supplemental therapy in the management of inflammatory bowel disease in the adolescent population.

Detailed Description
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Youth with IBD experience abdominal pain, diarrhea, weight loss, and psychological suffering related to their disease process. While many biologic and non-biologic therapies are available to target the inflammatory component of IBD, youth with IBD could benefit from a more holistic therapy that addresses psychological wellness, which has been shown, in turn, to reduce disease burden. It is known that stress (multiple varieties) leads to IBD flares. It is also known that mind-body intervention reduces stress. The mind-gut connection is widely discussed in medical circles, however, current therapies have not capitalized on it. The investigators would like to know if an easily accessible mind-body intervention (yoga) can improve wellness, lower stress levels, and reduce intestinal inflammation in youth with IBD. The study will be an 8-week feasibility pilot. Participants will be asked to participate in online yoga videos and in-studio yoga sessions. Participants will be asked to complete multiple surveys throughout the intervention and continue receiving standard care from their primary gastroenterology team.

Official Title
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The Effects of Yoga on Disease Activity in Youth With Inflammatory Bowel Disease: a Pilot Feasibility Study

Conditions
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Inflammatory Bowel Diseases, Yoga, Adolescents, Crohn Disease, Ulcerative Colitis

Intervention / Treatment
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* Behavioral: Yoga


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 10-21 Diagnosis of Crohn's Disease or Ulcerative Colitis Patient of a Stanford Children's Health or Stanford-affiliated Pediatric Gastroenterologist Ability to attend in-person meetings/training Exclusion Criteria: Initiation of biologic therapy in prior 3 months Hospital admission in prior 2 months Major surgery in prior 1 month PUCAI/PCDAI >65 Current pregnancy Severe developmental or intellectual disability Non-english speaking Not participating in another concurrent clinical trial

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Yoga|Yoga for 30 minutes three times weekly for 8 weeks in addition to three, 1-hour in-studio yoga sessions.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of acceptability | Focus Group | 1 hour focus group at conclusion of intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal Calprotectin | Stool biomarker that indicates intestinal inflammation | 6 weeks (Prior to intervention; After conclusion of intervention) | 
| Pediatric Ulcerative Colitis Activity Index | 5 question assessment tool for disease tracking for patient's with ulcerative colitis | 6 weeks (Prior to intervention; After conclusion of intervention) | 
| PROMIS-37 | NIH Pediatric Assessment Tool | 6 weeks (Prior to intervention; After conclusion of intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inflammatory bowel disease, adolescent, yoga, mind-body