A Trial of Yoga in Pediatric Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

Official title:

A Controlled Trial of Yoga in Pediatric Inflammatory Bowel Disease (IBD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03338894
• Other study ID #: YOGAL
• Status: Completed
• Phase: N/A
• Start date: December 13, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2023
• Source: Atlantic Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 31, 2021
• Est. primary completion date: March 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

Behavioral:
• Yoga
1 Hour yoga class

Locations

Country	Name	City	State
United States	Morristown Memorial Hospital/Goyerb Children's Hospital	Morristown	New Jersey
United States	Children's Hospital of Philadelphia/Roberts Center for Pediatric Research	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Atlantic Health System

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

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. doi: 10.1111/j.1440-1754.2004.00510.x. — View Citation

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. doi: 10.1111/j.1572-0241.2002.05474.x. — View Citation

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. doi: 10.1016/j.cgh.2006.04.008. Epub 2006 Jul 3. — View 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. — View Citation

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. doi: 10.1155/2006/731628. — View Citation

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. doi: 10.1016/j.cgh.2006.05.011. Epub 2006 Jul 24. — View 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. — View 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. — View Citation

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. doi: 10.1097/00005176-200210000-00018. — View 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. — View 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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.	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.