Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT05224193
Status:
RECRUITING
Last Update Posted:
2022-03-10
First Post:
2021-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ACTIVE-IBD Study: Physical Activity and Sleep in Paediatric Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-22', 'studyFirstSubmitDate': '2021-09-16', 'studyFirstSubmitQcDate': '2022-01-24', 'lastUpdatePostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of Life Score', 'timeFrame': 'At baseline clinic assessment', 'description': 'Paediatric Quality of Life Score - PEDSQL scored in psychosocial and physical sections. Both are scored out of 100 and the higher the score the better health related quality of life.'}], 'primaryOutcomes': [{'measure': 'Moderate Vigorous Physical Activity measurement', 'timeFrame': 'Over 1 Week', 'description': 'Amount of time spent performing moderate and vigorous physical activity'}, {'measure': 'Sedentary time', 'timeFrame': '1 week', 'description': 'Amount of time spent sedentary'}], 'secondaryOutcomes': [{'measure': 'Disease Activity', 'timeFrame': 'At Baseline Clinical Assessment', 'description': 'Disease activity scores using either PUCAI (/85) or PCDAI (/100). Higher scores indicate more active disease'}, {'measure': 'Perceived Physical Activity', 'timeFrame': 'At Baseline Clinical Assessment', 'description': 'Youth Physical Activity Scale - Subjective Assessment of Moderate Vigorous Physical Activity in Hours over a 1 week retrospective period'}, {'measure': 'Amount and Quality of Sleep', 'timeFrame': 'At Baseline Clinical Assessment', 'description': 'Child Sleep Health Questionnaire scored out of 154 total and is parent/ carer subjective sleep assessment. Scored in four separate domains. Higher scores indicate increased duration and quality of sleep'}, {'measure': 'Nutritional Assessment', 'timeFrame': 'At Baseline Clinical Assessment', 'description': 'Mid Upper Arm Circumference'}, {'measure': 'Growth Assessment', 'timeFrame': 'At Baseline Clinical Assessment', 'description': 'Height in meters'}, {'measure': 'Growth Assessment', 'timeFrame': 'At Baseline Clinical Assessment', 'description': 'Weight in kg'}, {'measure': 'Nutrition Assessment', 'timeFrame': '3 day assessment after baseline visit', 'description': '3 day self-reported food diary'}, {'measure': 'Amount and Quality of Sleep', 'timeFrame': '1 week period', 'description': 'Accelerometer measured sleep'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'Sleep', 'Quality of Life', 'Physical Activity'], 'conditions': ['Inflammatory Bowel Diseases', 'Exercise']}, 'descriptionModule': {'briefSummary': 'Assessment of physical activity on children with Inflammatory Bowel Disease using questionnaires and wrist watch based activity monitors.\n\nThe participants will be recruited from paediatric IBD clinics and will undergo questionnaires to assess their activity level, disease activity and quality of life scores. The participants will then be invited to wear a wrist based accelerometer for a week. The participants will complete a physical activity diary, food diary and stool chart at the same time.\n\nResults will be analysed to see the level of physical activity and assess if the participants are meeting the recommended level of physical activity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any disease known to interfere with exercise:\n\n* poorly controlled asthma\n* significant cardiovascular disease\n* fracture\n* infection\n\n * Unable to understand and/or cooperate with the study requirements\n * Unable to provide consent / assent to participate in the study\n * Participants will eb excluded if they are currently part of another exercise/ physical study\n * Unable to provide consent / assent to participate in study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children/adolescents from age of 6 to 18 years of age\n* Confirmed endoscopic/histology based IBD diagnosis\n* Under the care of the Southampton University Hospitals NHS Foundation Trust paediatric gastroenterology team\n* Able to provide consent / assent to participate in the study\n* Able to understand and/or cooperate with the study requirements\n* Pregnant participants will be included as long as they can complete the physical assessmentsExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT05224193', 'acronym': 'ACTIVE-IBD', 'briefTitle': 'ACTIVE-IBD Study: Physical Activity and Sleep in Paediatric Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Southampton NHS Foundation Trust'}, 'officialTitle': 'Physical ACTIVity, slEep, Fitness and Quality of Life in Children and Adolescents With Inflammatory Bowel Disease: a 5-year Prospective Observational Cohort Study - The ACTIVE-IBD Study', 'orgStudyIdInfo': {'id': 'RHM CHI1102'}, 'secondaryIdInfos': [{'id': '301029', 'type': 'OTHER', 'domain': 'IRAS'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Paediatric Patients with Inflammatory Bowel Disease'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SO16 6YD', 'city': 'Southampton', 'state': 'Hampshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Nadeem Afzal, MD', 'role': 'CONTACT', 'email': 'nadeem.afzal@uhs.nhs.uk', 'phone': '02381208546'}, {'name': 'Christopher Roberts, MBBS', 'role': 'CONTACT', 'email': 'chris.roberts@uhs.nhs.uk'}], 'facility': 'Univeristy Hospital Southampton', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Southampton NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}