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临床试验/NCT04757935
NCT04757935已完成不适用

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

Stanford University2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
2
主要终点
Assessment of acceptability

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
10 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Assessment of acceptability

时间窗: 1 hour focus group at conclusion of intervention.

Focus Group

次要结局

  • Fecal Calprotectin(6 weeks (Prior to intervention; After conclusion of intervention))
  • PROMIS-37(6 weeks (Prior to intervention; After conclusion of intervention))
  • Pediatric Ulcerative Colitis Activity Index(6 weeks (Prior to intervention; After conclusion of intervention))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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