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A Trial of Yoga in Pediatric Inflammatory Bowel Disease

Primary Purpose

Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Sponsored by
Atlantic Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Inflammatory Bowel Disease

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Both males and females patients with IBD
  • Ages 10-17 years
  • Not currently practicing specific mind-body techniques (yoga, pranayama - deep breathing, biofeedback, hypnosis, guide imagery)
  • Diagnosis of IBD

Exclusion Criteria:

  • Other chronic systemic disease ex. Rheumatoid arthritis, Cystic fibrosis, Celiac or chronic neurologic conditions

Sites / Locations

  • Morristown Memorial Hospital/Goyerb Children's Hospital
  • Children's Hospital of Philadelphia/Roberts Center for Pediatric Research

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Yoga group

Arm Description

Each subject will serve as their own control

Outcomes

Primary Outcome Measures

Pediatric Quality of Life Inventory
The number of patients diagnosed with Inflammatory Bowel disease that have shown an improved health related quality of life (HRQOL) as assessed by the Pediatric Quality of Life survey after a structured yoga program, comparing pre-yoga HRQOL to post-yoga HRQOL. The Peds QOL age related surveys are validated pediatric questionnaires that measure general HRQOL in children ages 8-17 years. They consist of 23 questions in areas of social, school, emotional and physical functioning. The answers are scored on a 5 point scale and then reverse scored and linearly transformed to a scale of 1-100 scale.

Secondary Outcome Measures

General Perceived Self Efficacy Scale
This is a 10 item scale that measures a patient's general sense of perceived self-efficacy, aiming to predict coping with daily life as well as adaptation after stressful life events. The General Self Efficacy Scale is correlated to emotion, optimism, and work satisfaction. Negative coefficients were found for depression, stress, health complaints, burnout and anxiety. The total score is calculated by finding the sum of all item. For the General Self-Efficacy, the total score ranges between 10 to 40, with a higher score indicating more self-efficacy.

Full Information

First Posted
November 7, 2017
Last Updated
September 15, 2023
Sponsor
Atlantic Health System
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1. Study Identification

Unique Protocol Identification Number
NCT03338894
Brief Title
A Trial of Yoga in Pediatric Inflammatory Bowel Disease
Official Title
A Controlled Trial of Yoga in Pediatric Inflammatory Bowel Disease (IBD)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 13, 2017 (Actual)
Primary Completion Date
March 18, 2020 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Atlantic Health System

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
IBD adds additional stressors as a chronic disease that has unpredictable and sometimes embarrassing symptoms to the normal challenges that teenagers face. Stress and how stressful events are perceived, may contribute to worsening of disease. Complementary and alternative medicine (CAM), are used often by pediatric IBD patients and maybe beneficial in decreasing stress and improving quality of life. Yoga could be a well suited paring with standard medical therapy to decrease and provide a better sense of control and improve quality of life.
Detailed Description
Approximately 25% of Inflammatory bowel disease (IBD) is diagnosed in the pediatric age group, with the peak age of onset in the adolescent years. IBD adds additional stressors of a chronic disease with unpredictable and potentially embarrassing symptoms to the expected challenges of psychological and social adjustment that teenagers face. Various techniques, such as psychotherapy programs and IBD overnight camp experiences, have been studied to decrease psychological distress and improve quality of life. Stress, and particularly how stressful events are perceived, may play a role in triggering IBD flares. Complementary and alternative medicine (CAM), especially mind-body techniques are used often by pediatric IBD patients and may be beneficial in decreasing stress and improving quality of life (QOL). Yoga may be well suited as an adjunct to conventional IBD therapy to decrease stress, provide a greater sense of bodily control and improve QOL. The primary goal of this project is to determine if a structured Yoga program, in addition to standard medical therapy, improves HRQOL in pediatric patients diagnosed with inflammatory bowel disease (IBD). Investigators will also examine if the yoga program improves self efficacy, which is a person's belief about their ability to influence events that affect their lives. Disease response and remission rates will be followed as well, in order to stratify HRQOL outcomes in the yoga group. Patients will each serve as their own control and complete questionnaires at enrollment and at the start and end of the 12 week group yoga class sessions. They will also complete the questionnaires three months after finishing the class sessions. .The program will consist of a live group class session over 12 weeks. Baseline and follow-up questionnaires will be used to determine there are changes in QOL, self-efficacy, and disease response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Yoga group
Arm Type
Other
Arm Description
Each subject will serve as their own control
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Description
1 Hour yoga class
Primary Outcome Measure Information:
Title
Pediatric Quality of Life Inventory
Description
The number of patients diagnosed with Inflammatory Bowel disease that have shown an improved health related quality of life (HRQOL) as assessed by the Pediatric Quality of Life survey after a structured yoga program, comparing pre-yoga HRQOL to post-yoga HRQOL. The Peds QOL age related surveys are validated pediatric questionnaires that measure general HRQOL in children ages 8-17 years. They consist of 23 questions in areas of social, school, emotional and physical functioning. The answers are scored on a 5 point scale and then reverse scored and linearly transformed to a scale of 1-100 scale.
Time Frame
Compared difference from enrollment (time0) to start yoga class (time1), to difference from first yoga class (time1) to last yoga class (time2) 90 days, difference from first yoga class (time1) to 3 months after last yoga class (time 3) 180 days.
Secondary Outcome Measure Information:
Title
General Perceived Self Efficacy Scale
Description
This is a 10 item scale that measures a patient's general sense of perceived self-efficacy, aiming to predict coping with daily life as well as adaptation after stressful life events. The General Self Efficacy Scale is correlated to emotion, optimism, and work satisfaction. Negative coefficients were found for depression, stress, health complaints, burnout and anxiety. The total score is calculated by finding the sum of all item. For the General Self-Efficacy, the total score ranges between 10 to 40, with a higher score indicating more self-efficacy.
Time Frame
Compared difference from enrollment (time0) to start yoga class (time1), to difference from first yoga class (time1) to last yoga class (time2) 90 days, difference from first yoga class (time1) to 3 months after last yoga class (time 3) 180 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both males and females patients with IBD Ages 10-17 years Not currently practicing specific mind-body techniques (yoga, pranayama - deep breathing, biofeedback, hypnosis, guide imagery) Diagnosis of IBD Exclusion Criteria: Other chronic systemic disease ex. Rheumatoid arthritis, Cystic fibrosis, Celiac or chronic neurologic conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alycia Leiby, MD
Organizational Affiliation
Atlantic Health/Goryeb Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Morristown Memorial Hospital/Goyerb Children's Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Children's Hospital of Philadelphia/Roberts Center for Pediatric Research
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15677910
Citation
Shepanski MA, Hurd LB, Culton K, Markowitz JE, Mamula P, Baldassano RN. Health-related quality of life improves in children and adolescents with inflammatory bowel disease after attending a camp sponsored by the Crohn's and Colitis Foundation of America. Inflamm Bowel Dis. 2005 Feb;11(2):164-70. doi: 10.1097/00054725-200502000-00010.
Results Reference
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PubMed Identifier
20848505
Citation
McCormick M, Reed-Knight B, Lewis JD, Gold BD, Blount RL. Coping skills for reducing pain and somatic symptoms in adolescents with IBD. Inflamm Bowel Dis. 2010 Dec;16(12):2148-57. doi: 10.1002/ibd.21302.
Results Reference
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PubMed Identifier
19337242
Citation
Singh S, Graff LA, Bernstein CN. Do NSAIDs, antibiotics, infections, or stress trigger flares in IBD? Am J Gastroenterol. 2009 May;104(5):1298-313; quiz 1314. doi: 10.1038/ajg.2009.15. Epub 2009 Mar 31.
Results Reference
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PubMed Identifier
19172124
Citation
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Results Reference
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PubMed Identifier
15472521
Citation
Markowitz JE, Mamula P, delRosario JF, Baldassano RN, Lewis JD, Jawad AF, Culton K, Strom BL. Patterns of complementary and alternative medicine use in a population of pediatric patients with inflammatory bowel disease. Inflamm Bowel Dis. 2004 Sep;10(5):599-605. doi: 10.1097/00054725-200409000-00015.
Results Reference
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11866277
Citation
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Results Reference
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PubMed Identifier
15569284
Citation
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Citation
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Citation
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Citation
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Citation
Hyams J, Markowitz J, Otley A, Rosh J, Mack D, Bousvaros A, Kugathasan S, Pfefferkorn M, Tolia V, Evans J, Treem W, Wyllie R, Rothbaum R, del Rosario J, Katz A, Mezoff A, Oliva-Hemker M, Lerer T, Griffiths A; Pediatric Inflammatory Bowel Disease Collaborative Research Group. Evaluation of the pediatric crohn disease activity index: a prospective multicenter experience. J Pediatr Gastroenterol Nutr. 2005 Oct;41(4):416-21. doi: 10.1097/01.mpg.0000183350.46795.42.
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A Trial of Yoga in Pediatric Inflammatory Bowel Disease

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