Yoga for Youth With IBD: a Pilot Feasibility Study

NCT04757935 | Completed

• 1 other identifier: IRB Protocol 37755
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

inflammatory bowel disease; adolescent; yoga; mind-body

Outcome Measures

Primary Outcomes (1)

• Assessment of acceptability

  Focus Group

  1 hour focus group at conclusion of intervention.

Secondary Outcomes (3)

• Fecal Calprotectin

  6 weeks (Prior to intervention; After conclusion of intervention)

• Pediatric Ulcerative Colitis Activity Index

  6 weeks (Prior to intervention; After conclusion of intervention)

• PROMIS-37

  6 weeks (Prior to intervention; After conclusion of intervention)

Interventions

Yoga BEHAVIORAL

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

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

Yoga

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Ann Ming Yeh, MD

  Clinician Educator at Stanford University

  PRINCIPAL INVESTIGATOR

• Jenna Marie Arruda, MD, MPH

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: February 17, 2021
• Study Start: January 1, 2017
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: February 17, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)