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Yoga for Youth With IBD: a Pilot Feasibility Study

Primary Purpose

Inflammatory Bowel Diseases, Yoga, Adolescents

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Sponsored by
Stanford University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring inflammatory bowel disease, adolescent, yoga, mind-body

Eligibility Criteria

10 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lucile Packard Children's Hospital

Outcomes

Primary Outcome Measures

Assessment of acceptability
Focus Group

Secondary Outcome Measures

Fecal Calprotectin
Stool biomarker that indicates intestinal inflammation
Pediatric Ulcerative Colitis Activity Index
5 question assessment tool for disease tracking for patient's with ulcerative colitis
PROMIS-37
NIH Pediatric Assessment Tool

Full Information

First Posted
September 6, 2018
Last Updated
February 16, 2021
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04757935
Brief Title
Yoga for Youth With IBD: a Pilot Feasibility Study
Official Title
The Effects of Yoga on Disease Activity in Youth With Inflammatory Bowel Disease: a Pilot Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
May 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Yoga, Adolescents, Crohn Disease, Ulcerative Colitis
Keywords
inflammatory bowel disease, adolescent, yoga, mind-body

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Description
Yoga for 30 minutes three times weekly for 8 weeks in addition to three, 1-hour in-studio yoga sessions.
Primary Outcome Measure Information:
Title
Assessment of acceptability
Description
Focus Group
Time Frame
1 hour focus group at conclusion of intervention.
Secondary Outcome Measure Information:
Title
Fecal Calprotectin
Description
Stool biomarker that indicates intestinal inflammation
Time Frame
6 weeks (Prior to intervention; After conclusion of intervention)
Title
Pediatric Ulcerative Colitis Activity Index
Description
5 question assessment tool for disease tracking for patient's with ulcerative colitis
Time Frame
6 weeks (Prior to intervention; After conclusion of intervention)
Title
PROMIS-37
Description
NIH Pediatric Assessment Tool
Time Frame
6 weeks (Prior to intervention; After conclusion of intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Ming Yeh, MD
Organizational Affiliation
Clinician Educator at Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jenna Marie Arruda, MD, MPH
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lucile Packard Children's Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Yoga for Youth With IBD: a Pilot Feasibility Study

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