Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT05392920
Status:
UNKNOWN
Last Update Posted:
2022-07-08
First Post:
2022-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Determination of the Validity of One-Minute Sit-to-Stand Test in Obese and Overweight Children and Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-06-28', 'releaseDate': '2023-12-27'}], 'estimatedResultsFirstSubmitDate': '2023-12-27'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}], 'ancestors': [{'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-11-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-07', 'studyFirstSubmitDate': '2022-05-15', 'studyFirstSubmitQcDate': '2022-05-23', 'lastUpdatePostDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1 min sit to stand test', 'timeFrame': 'Baseline', 'description': 'Only a chair and a stopwatch are needed to apply the test. It is recommended to use a chair with a height of 45-48 cm, preferably against the wall, fixed, without arm support. The patients will sit with their feet flat on the ground and cross their arms over the chest. The patient will be asked to get up from the chair and sit down as fast as he/she can for 1 minute. The number of standing up will be recorded.'}, {'measure': '6 minute walk test', 'timeFrame': 'Baseline', 'description': "The patient's exercise capacity will be determined by the six minute walk test. The test will be applied in a corridor 30 meters long. The patient will be asked to walk as fast as possible for six minutes. The patient can stop during the test if they needed. The total time, the number of times it has stopped and the total distance traveled will be recorded. Oxygen saturation, heart rate, and blood pressure measurements will be taken before and after the test. According to the modified Borg scale, dyspnea, leg fatigue and general fatigue will be questioned."}], 'secondaryOutcomes': [{'measure': 'Waist circumference', 'timeFrame': 'Baseline', 'description': 'Waist circumference will be measured using a tape measure from the midpoint between the lowest rib and the iliac crest, when the patient is standing .'}, {'measure': 'Hip circumference', 'timeFrame': 'Baseline', 'description': 'Hip circumference will be measured parallel to the ground with a tape measure at the level of the trochanter major.'}, {'measure': 'Body fat percentage', 'timeFrame': 'Baseline', 'description': 'Body fat percentage will be analyzed with the BIA instrument (Tanita MC 780 MA Body Composition Analysis, Amsterdam, Netherlands).'}, {'measure': 'Body muscle percentage', 'timeFrame': 'Baseline', 'description': 'Body muscle percentage will be analyzed with the BIA instrument (Tanita MC 780 MA Body Composition Analysis, Amsterdam, Netherlands).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obese patient', 'functional test', 'reliability', 'validity'], 'conditions': ['Obese', 'Child Obesity', 'Adolescent Obesity', 'Exercise Capacity']}, 'referencesModule': {'references': [{'pmid': '30489442', 'type': 'BACKGROUND', 'citation': 'Bohannon RW, Crouch R. 1-Minute Sit-to-Stand Test: SYSTEMATIC REVIEW OF PROCEDURES, PERFORMANCE, AND CLINIMETRIC PROPERTIES. J Cardiopulm Rehabil Prev. 2019 Jan;39(1):2-8. doi: 10.1097/HCR.0000000000000336.'}, {'pmid': '12091180', 'type': 'BACKGROUND', 'citation': 'ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.'}, {'pmid': '26831556', 'type': 'BACKGROUND', 'citation': 'Ozgen IT, Cakir E, Torun E, Gules A, Hepokur MN, Cesur Y. Relationship Between Functional Exercise Capacity and Lung Functions in Obese Chidren. J Clin Res Pediatr Endocrinol. 2015 Sep;7(3):217-21. doi: 10.4274/jcrpe.1990.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/30489442/', 'label': 'Related Info'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/12091180/', 'label': 'Related Info'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/26831556/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "Obese individuals need to be evaluated comprehensively before exercise programs are determined. Determination of exercise intolerance is important for the detection of functional limitations. One minute sit to stand test (1MSTST) can be used as an alternative to cardiopulmonary exercise tests (CPET) or field tests. It is easy to use, quick to apply, valid and reliable, and applicable even in small areas. In addition, it is a simple assessment adequate for children's needs and behaviors and can be easily applied both in the clinic and at home, making it easier to use in children. Studies have shown that 1MSTST is a valid test in chronic obstructive pulmonary disease (COPD), cystic fibrosis, interstitial lung disease, and, healthy children and adolescents. However, no study has been found regarding the validity of its use in obese children and adolescents.The aim of our study is to investigate the validity and reliability of 1MSTST in overweight-obese children and adolescents."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Overweight or obese children and adolescents', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being in the 8-18 age range.\n* Being overweight (between 85 and 95 according to the Body Mass Index percentile).\n* Being obese (over 95 based on the Body Mass Index percentile).\n* Not doing any vigorous exercise two hours before the test.\n\nExclusion Criteria:\n\n* History of hospitalization in the last month for a reason that may affect physical performance.\n* Having neurological, musculoskeletal disease that prevents exercise tests.\n* Uncontrollable medical conditions (Cardiovascular, pulmonary disease, etc.).\n* Visual and/or vestibular disorders.'}, 'identificationModule': {'nctId': 'NCT05392920', 'briefTitle': 'Determination of the Validity of One-Minute Sit-to-Stand Test in Obese and Overweight Children and Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'Determination of the Validity of One-Minute Sit-to-Stand Test in Obese and Overweight Children and Adolescents', 'orgStudyIdInfo': {'id': '2022/37'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obese children and adolescents', 'description': 'Obese children and adolescent patients', 'interventionNames': ['Other: assessment study']}], 'interventions': [{'name': 'assessment study', 'type': 'OTHER', 'description': 'there is no intervention in this study', 'armGroupLabels': ['Obese children and adolescents']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34500', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Nesrine Benkhalifa, PT', 'role': 'CONTACT', 'email': 'noussabk93@gmail.com', 'phone': '+905418191403'}], 'facility': 'Istanbul University-Cerrahpasa', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Nesrine Benkhalifa, PT', 'role': 'CONTACT', 'email': 'nesrine.benkhalifa@ogr.iuc.edu.tr', 'phone': '+905418191403'}, {'name': 'Cigdem Emirza, PT, MSc', 'role': 'CONTACT', 'email': 'cgdemrza@gmail.com', 'phone': '+902123115136'}], 'overallOfficials': [{'name': 'Goksen Kuran Aslan, PT, phD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istanbul University - Cerrahpasa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'nesrine benkhalifa', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-12-27', 'type': 'RELEASE'}, {'date': '2024-06-28', 'type': 'RESET'}], 'unpostedResponsibleParty': 'nesrine benkhalifa, Principal Investigator, Istanbul University - Cerrahpasa'}}}}