Yoga for Youth With IBD: a Pilot Feasibility Study

NCT ID: NCT04757935

Last Updated: 2021-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2017-05-31

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.

Conditions

Inflammatory Bowel Diseases; Yoga; Adolescents; Crohn Disease; Ulcerative Colitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Yoga

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ann Ming Yeh, MD

Role: PRINCIPAL_INVESTIGATOR

Clinician Educator at Stanford University

Jenna Marie Arruda, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Lucile Packard Children's Hospital

Palo Alto, California, United States

Countries

United States

Other Identifiers

IRB Protocol 37755

Identifier Type: -

Identifier Source: org_study_id