Clinical trial NCT03338894: 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
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 78
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Pediatric Quality of Life Inventory
timeFrame: 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 outcomes:
measure: General Perceived Self Efficacy Scale
timeFrame: 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.
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Morristown Memorial Hospital/Goyerb Children's Hospital
state: New Jersey
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia/Roberts Center for Pediatric Research
state: Pennsylvania
Study officials:
affiliation: Atlantic Health/Goryeb Children's Hospital
name: Alycia Leiby, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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