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A Trial of Yoga in Pediatric Inflammatory Bowel Disease

This study is currently recruiting participants.
Verified November 2017 by Alycia Leiby, MD, Atlantic Health System
Sponsor:
ClinicalTrials.gov Identifier:
NCT03338894
First Posted: November 9, 2017
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Alycia Leiby, MD, Atlantic Health System
  Purpose
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.

Condition Intervention
Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis Behavioral: Yoga

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Controlled Trial of Yoga in Pediatric Inflammatory Bowel Disease (IBD)

Resource links provided by NLM:


Further study details as provided by Alycia Leiby, MD, Atlantic Health System:

Primary Outcome Measures:
  • Pediatric Quality of Life [ Time Frame: 90 Days ]
    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 Self Efficacy Scale [ Time Frame: 90 days ]
    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.


Estimated Enrollment: 80
Anticipated Study Start Date: November 2017
Estimated Study Completion Date: November 1, 2020
Estimated Primary Completion Date: November 1, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Yoga group
Each subject will serve as their own control
Behavioral: Yoga
1 Hour yoga class

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338894


Contacts
Contact: Alycia Leiby, MD 973-971-5676 alycia.leiby@atlantichealth.org
Contact: Annette Langseder, RN, BSN 973-971-5676 annette.langseder@atlantichealth.org

Locations
United States, New Jersey
Morristown Memorial Hospital/Goyerb Children's Hospital Recruiting
Morristown, New Jersey, United States, 07962
Contact: Research Coordinator    973-971-5676      
United States, Pennsylvania
Children's Hospital of Philadelphia/Roberts Center for Pediatric Research Recruiting
Philadelphia, Pennsylvania, United States, 19146
Contact: Naomi Pressman, MS, RD    267-426-8413      
Sponsors and Collaborators
Atlantic Health System
Investigators
Principal Investigator: Alycia Leiby, MD Atlantic Health/Goryeb Children's Hospital
  More Information

Publications:

Responsible Party: Alycia Leiby, MD, Principal Investigator, Atlantic Health System
ClinicalTrials.gov Identifier: NCT03338894     History of Changes
Other Study ID Numbers: YOGAL
First Submitted: November 7, 2017
First Posted: November 9, 2017
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colitis
Colonic Diseases