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OpenTrials
Completed

NCT Number: NCT04757935

Yoga for Youth With IBD: 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.

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Key information

Age range

10 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Yoga

Behavioral

Yoga for 30 minutes three times weekly for 8 weeks in addition to three, 1-hour in-studio yoga sessions.

Primary outcomes

  1. Assessment of acceptability

    Time frame: 1 hour focus group at conclusion of intervention.

    Focus Group

Secondary outcomes

  1. Fecal Calprotectin

    Time frame: 6 weeks (Prior to intervention; After conclusion of intervention)

    Stool biomarker that indicates intestinal inflammation

  2. Pediatric Ulcerative Colitis Activity Index

    Time frame: 6 weeks (Prior to intervention; After conclusion of intervention)

    5 question assessment tool for disease tracking for patient's with ulcerative colitis

  3. PROMIS-37

    Time frame: 6 weeks (Prior to intervention; After conclusion of intervention)

    NIH Pediatric Assessment Tool

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 17, 2021
Registry last updated
Feb 17, 2021

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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