Yoga for Youth With IBD: a Pilot Feasibility Study

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Yoga; Adolescents
• Intervention / Treatment: Behavioral: Yoga

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Lucile Packard Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Ann Ming Yeh, MD, Clinician Educator at Stanford University; Principal Investigator: Jenna Marie Arruda, MD, MPH, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): May 31, 2017
• Study Completion (Actual): May 31, 2017

Study Registration Dates

• First Submitted: September 6, 2018
• First Submitted That Met QC Criteria: February 16, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Actual): February 17, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: adolescent; yoga; inflammatory bowel disease; mind-body
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases
• Other Study ID Numbers: IRB Protocol 37755

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No