Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-01-07 @ 5:36 PM
Study NCT ID:
NCT03338894
Status:
COMPLETED
Last Update Posted:
2023-09-18
First Post:
2017-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Trial of Yoga in Pediatric Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015013', 'term': 'Yoga'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alycia.leiby@atlantichealth.org', 'phone': '973--971-5676', 'title': 'Dr. Alycia Leiby', 'organization': "Atlantic Children's Health/Atlantic Health Outpatient"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 month', 'eventGroups': [{'id': 'EG000', 'title': 'Yoga Group', 'description': 'Each subject will serve as their own control\n\nYoga: 1 Hour yoga class', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pediatric Quality of Life Inventory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Yoga Group', 'description': 'Each subject will serve as their own control\n\nYoga: 1 Hour yoga class'}], 'classes': [{'title': 'time 0 to time 1', 'categories': [{'measurements': [{'value': '2.14', 'spread': '8.79', 'groupId': 'OG000'}]}]}, {'title': 'time 1 to time 2', 'categories': [{'measurements': [{'value': '1.5', 'spread': '8.01', 'groupId': 'OG000'}]}]}, {'title': 'time 1 to time 3', 'categories': [{'measurements': [{'value': '2.8', 'spread': '10.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', '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.', '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'General Perceived Self Efficacy Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Yoga Group', 'description': 'Each subject will serve as their own control\n\nYoga: 1 Hour yoga class'}], 'classes': [{'title': 'Time 0 to Time 1', 'categories': [{'measurements': [{'value': '0.27', 'spread': '3.89', 'groupId': 'OG000'}]}]}, {'title': 'Time 1 to Time 2', 'categories': [{'measurements': [{'value': '0.4', 'spread': '4.32', 'groupId': 'OG000'}]}]}, {'title': 'Time 1 to Time 3', 'categories': [{'measurements': [{'value': '1', 'spread': '3.603', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', '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.', '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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Yoga Group', 'description': 'Each subject will serve as their own control\n\nYoga: 1 Hour yoga class'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Withdrew, or not able to attend 9 or more classes, or did not complete final survey.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}]}]}], 'recruitmentDetails': 'Study enrollment was offered during office or infusion visit. Recruitment began December 2017 and closed August 2019.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Yoga Group', 'description': 'Each subject will serve as their own control\n\nYoga: 1 Hour yoga class'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000', 'lowerLimit': '12', 'upperLimit': '15'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Inflammatory Bowel Disease Type', 'classes': [{'title': "Crohn's Disease", 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}, {'title': 'Ulcerative Colitis/Inflammatory Bowel Disease unspecified', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-14', 'size': 273476, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-22T13:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-15', 'studyFirstSubmitDate': '2017-11-07', 'resultsFirstSubmitDate': '2021-03-22', 'studyFirstSubmitQcDate': '2017-11-08', 'lastUpdatePostDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-13', 'studyFirstPostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', '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.'}], 'secondaryOutcomes': [{'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.', '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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Disease', "Crohn's Disease", 'Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '15677910', 'type': 'BACKGROUND', '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."}, {'pmid': '20848505', 'type': 'BACKGROUND', '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.'}, {'pmid': '19337242', 'type': 'BACKGROUND', '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.'}, {'pmid': '19172124', 'type': 'BACKGROUND', '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.'}, {'pmid': '15472521', 'type': 'BACKGROUND', '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.'}, {'pmid': '11866277', 'type': 'BACKGROUND', '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.'}, {'pmid': '15569284', 'type': 'BACKGROUND', '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.'}, {'pmid': '19705417', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17149454', 'type': 'BACKGROUND', '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.'}, {'pmid': '12394384', 'type': 'BACKGROUND', '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.'}, {'pmid': '16205508', 'type': 'BACKGROUND', '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.'}, {'pmid': '16820327', 'type': 'BACKGROUND', '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.'}, {'pmid': '16861053', 'type': 'BACKGROUND', '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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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.\n\nPatients 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both males and females patients with IBD\n* Ages 10-17 years\n* Not currently practicing specific mind-body techniques (yoga, pranayama - deep breathing, biofeedback, hypnosis, guide imagery)\n* Diagnosis of IBD\n\nExclusion Criteria:\n\n* Other chronic systemic disease ex. Rheumatoid arthritis, Cystic fibrosis, Celiac or chronic neurologic conditions'}, 'identificationModule': {'nctId': 'NCT03338894', 'briefTitle': 'A Trial of Yoga in Pediatric Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'Atlantic Health System'}, 'officialTitle': 'A Controlled Trial of Yoga in Pediatric Inflammatory Bowel Disease (IBD)', 'orgStudyIdInfo': {'id': 'YOGAL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Yoga group', 'description': 'Each subject will serve as their own control', 'interventionNames': ['Behavioral: Yoga']}], 'interventions': [{'name': 'Yoga', 'type': 'BEHAVIORAL', 'description': '1 Hour yoga class', 'armGroupLabels': ['Yoga group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07962', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': "Morristown Memorial Hospital/Goyerb Children's Hospital", 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '19146', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia/Roberts Center for Pediatric Research", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Alycia Leiby, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Atlantic Health/Goryeb Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atlantic Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alycia Leiby, MD', 'investigatorAffiliation': 'Atlantic Health System'}}}}