A Trial of Yoga in Pediatric Inflammatory Bowel Disease

• Sponsor: Atlantic Health System (Other)
• Overall Status: Completed
• CT.gov ID: NCT03338894
• Collaborator: (none)
• Enrollment: 66
• Locations: 2
• Arm: 1
• Actual Duration (Months): 48.6
• Patients Per Site: 33
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis	Behavioral: Yoga	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: N/A
• 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)
• Actual Study Start Date: Dec 13, 2017
• Actual Primary Completion Date: Mar 18, 2020
• Actual Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Yoga group Each subject will serve as their own control	Behavioral: Yoga; 1 Hour yoga class

Outcome Measures

Primary Outcome Measures

1. Pediatric Quality of Life Inventory [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.]

   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

1. General Perceived Self Efficacy Scale [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.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Morristown Memorial Hospital/Goyerb Children's Hospital	Morristown	New Jersey	United States	07962
2	Children's Hospital of Philadelphia/Roberts Center for Pediatric Research	Philadelphia	Pennsylvania	United States	19146

Sponsors and Collaborators

• Atlantic Health System

Investigators

• Principal Investigator: Alycia Leiby, MD, Atlantic Health/Goryeb Children's Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 14, 2021

More Information

Publications

• Cotton S, Humenay Roberts Y, Tsevat J, Britto MT, Succop P, McGrady ME, Yi MS. Mind-body complementary alternative medicine use and quality of life in adolescents with inflammatory bowel disease. Inflamm Bowel Dis. 2010 Mar;16(3):501-6. doi: 10.1002/ibd.21045.
• Day AS, Whitten KE, Bohane TD. Use of complementary and alternative medicines by children and adolescents with inflammatory bowel disease. J Paediatr Child Health. 2004 Dec;40(12):681-4.
• Heuschkel R, Afzal N, Wuerth A, Zurakowski D, Leichtner A, Kemper K, Tolia V, Bousvaros A. Complementary medicine use in children and young adults with inflammatory bowel disease. Am J Gastroenterol. 2002 Feb;97(2):382-8.
• Hyams J, Markowitz J, Lerer T, Griffiths A, Mack D, Bousvaros A, Otley A, Evans J, Pfefferkorn M, Rosh J, Rothbaum R, Kugathasan S, Mezoff A, Wyllie R, Tolia V, delRosario JF, Moyer MS, Oliva-Hemker M, Leleiko N; Pediatric Inflammatory Bowel Disease Collaborative Research Group. The natural history of corticosteroid therapy for ulcerative colitis in children. Clin Gastroenterol Hepatol. 2006 Sep;4(9):1118-23. Epub 2006 Jul 3.
• 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.
• Kuttner L, Chambers CT, Hardial J, Israel DM, Jacobson K, Evans K. A randomized trial of yoga for adolescents with irritable bowel syndrome. Pain Res Manag. 2006 Winter;11(4):217-23.
• Markowitz J, Hyams J, Mack D, Leleiko N, Evans J, Kugathasan S, Pfefferkorn M, Mezoff A, Rosh J, Tolia V, Otley A, Griffiths A, Moyer MS, Oliva-Hemker M, Wyllie R, Rothbaum R, Bousvaros A, Del Rosario JF, Hale S, Lerer T; Pediatric IBD Collaborative Research Group. Corticosteroid therapy in the age of infliximab: acute and 1-year outcomes in newly diagnosed children with Crohn's disease. Clin Gastroenterol Hepatol. 2006 Sep;4(9):1124-9. Epub 2006 Jul 24.
• 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.
• 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.
• Otley A, Smith C, Nicholas D, Munk M, Avolio J, Sherman PM, Griffiths AM. The IMPACT questionnaire: a valid measure of health-related quality of life in pediatric inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 2002 Oct;35(4):557-63.
• 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.
• 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. Review.
• Wong AP, Clark AL, Garnett EA, Acree M, Cohen SA, Ferry GD, Heyman MB. Use of complementary medicine in pediatric patients with inflammatory bowel disease: results from a multicenter survey. J Pediatr Gastroenterol Nutr. 2009 Jan;48(1):55-60. doi: 10.1097/MPG.0b013e318169330f.

• Responsible Party: Alycia Leiby, MD, Principal Investigator, Atlantic Health System
• ClinicalTrials.gov Identifier: NCT03338894
• Other Study ID Numbers: YOGAL
• First Posted: Nov 9, 2017
• Last Update Posted: Jul 26, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• 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; Intestinal Diseases; Inflammatory Bowel Diseases

Study Results

Participant Flow

Arm/Group Title	Yoga Group
Arm/Group Description	Each subject will serve as their own control Yoga: 1 Hour yoga class
Period Title: Overall Study
STARTED	66
COMPLETED	56
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	Yoga Group
Arm/Group Description	Each subject will serve as their own control Yoga: 1 Hour yoga class
Overall Participants	56
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	13
Sex: Female, Male (Count of Participants)
Female	39 69.6%
Male	17 30.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 5.4%
Not Hispanic or Latino	49 87.5%
Unknown or Not Reported	4 7.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	3 5.4%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 1.8%
White	42 75%
More than one race	0 0%
Unknown or Not Reported	10 17.9%
Region of Enrollment (participants) [Number]
United States	56 100%
Inflammatory Bowel Disease Type (Count of Participants)
Crohn's Disease	41 73.2%
Ulcerative Colitis/Inflammatory Bowel Disease unspecified	15 26.8%

Outcome Measures

1. Primary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Yoga Group
Arm/Group Description	Each subject will serve as their own control Yoga: 1 Hour yoga class
Measure Participants	54
time 0 to time 1	2.14 (8.79)
time 1 to time 2	1.5 (8.01)
time 1 to time 3	2.8 (10.24)

2. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Yoga Group
Arm/Group Description	Each subject will serve as their own control Yoga: 1 Hour yoga class
Measure Participants	54
Time 0 to Time 1	0.27 (3.89)
Time 1 to Time 2	0.4 (4.32)
Time 1 to Time 3	1 (3.603)

Adverse Events

Time Frame	6 month
Arm/Group Title	Yoga Group
Arm/Group Description	Each subject will serve as their own control Yoga: 1 Hour yoga class
All Cause Mortality
	Yoga Group
	Affected / at Risk (%)	# Events
Total	0/56 (0%)
Serious Adverse Events
	Yoga Group
	Affected / at Risk (%)	# Events
Total	0/56 (0%)
Other (Not Including Serious) Adverse Events
	Yoga Group
	Affected / at Risk (%)	# Events
Total	0/56 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.