Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-02-28 @ 10:21 PM
Study NCT ID:
NCT04201158
Status:
COMPLETED
Last Update Posted:
2020-05-05
First Post:
2019-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Activities of Daily Living, Physical Fitness and Quality of Life in Obese and Healthy Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-02', 'studyFirstSubmitDate': '2019-12-13', 'studyFirstSubmitQcDate': '2019-12-13', 'lastUpdatePostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Modified shuttle walk test.', 'timeFrame': 'February 2019-February 2020', 'description': 'Maximal exercise capacity'}], 'secondaryOutcomes': [{'measure': 'Waist circumference, Abdominal circumference, Ratio of waist to hip', 'timeFrame': 'February 2019-February 2020', 'description': 'Antropometric measurements'}, {'measure': 'Hand grip strength by hand dynamometer (Jamar).', 'timeFrame': 'February 2019-February 2020', 'description': 'Peripheral Muscle Strength'}, {'measure': 'the Glittre Activities of Daily Living (ADL) Test.', 'timeFrame': 'February 2019-February 2020', 'description': 'Activities of daily living'}, {'measure': 'the Munich Physical Fitness Test-MFT', 'timeFrame': 'February 2019-February 2020', 'description': 'Physical Fitness'}, {'measure': 'Modified push-ups, shuttles and squats as possible for 30 seconds', 'timeFrame': 'February 2019-February 2020', 'description': 'Peripheral muscle endurance'}, {'measure': 'The Pediatric Outcomes Data Collection Instrument (PODCI)', 'timeFrame': 'February 2019-February 2020', 'description': 'Quality of Life'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Physical Fitness', 'Exercise Capacity', 'Activities of Daily Living', 'Quality of Life'], 'conditions': ['Obesity, Childhood', 'Healthy']}, 'descriptionModule': {'briefSummary': 'It is known that activities of daily living, physical fitness, exercise capacity and quality of life are affected by the obesity. It is aimed to determine the effects obesity on daily living activities, physical fitness, exercise capacity and quality of life in obese adolescents compared to healthy subjects in this study. The relationship between these parameters and the activities of daily living which are less studied in obese adolescents will be evaluated.', 'detailedDescription': 'Obesity among children, adolescents and adults has emerged as one of the most serious public health problems in the 21st century. There has been a significant decrease in the exercise capacity, physical fitness and activities of daily living of children and adolescents with the increase in the prevalence of obesity over the last decade. Obesity can cause not only health problems but also psychological effects. This situation have negative effects on the quality of life. The effect of these parameters on healthy individuals and obese adolescents will be demonstrated by this study and will guide the rehabilitation of obese adolescents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '15 obese adolescents, 15 obese adolescent adolescents and 15 healthy female adolescents and 15 healthy male adolescents compatible with age and sex will be recruited from obese adolescents according to the BMI reference system.', 'genderDescription': '15 obese adolescents, 15 obese adolescent adolescents and 15 healthy female adolescents and 15 healthy male adolescents compatible with age and sex will be recruited from obese adolescents according to the BMI reference system.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy group:\n\n* Being normal weight according to BMI reference system,\n* Being between the ages of 10-18 and volunteer to participate in the research,\n* Being able to walk and cooperate\n\nObese Group:\n\n* Obesity diagnosis according to BMI reference system,\n* Being between the ages of 10-18 and volunteer to participate in the research,\n* Being able to walk and cooperate.\n\nExclusion Criteria:\n\nHealthy Group:\n\n* Comorbidities that may affect exercise performance and other physical tests,\n* Having cardiovascular problems, musculoskeletal and neurological disease,\n* Having cognitive or motor limitation or other chronic diseases.\n\nObese Group:\n\n* Having a neurological disease or other clinical diagnosis that may affect cognitive status,\n* Having musculoskeletal and neurological diseases, symptomatic heart disease, lung disease, diabetes, hypertension and malignant disease that may affect exercise performance,\n* Using medication that affects appetite and weight.'}, 'identificationModule': {'nctId': 'NCT04201158', 'briefTitle': 'A Comparison of Activities of Daily Living, Physical Fitness and Quality of Life in Obese and Healthy Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'A Comparison of Activities of Daily Living, Physical Fitness and Quality of Life in Obese and Healthy Adolescents', 'orgStudyIdInfo': {'id': 'GO19/60'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obese Group (Girl)', 'description': 'Diagnosed with the obesity according to body mass index reference system, being 10-18 years old, being volunteer for the research and able to walk and cooperate are the inclusion criteria.Diagnosed with a neurological disease or another clinical diagnosis that may affect the cognitive state, musculoskeletal and neurological disease, symptomatic heart disease, lung disease, diabetes, hypertension and malignant disease, which may affect the performance of exercise and using the drug that affects appetite and weight are the exclusion criteria.', 'interventionNames': ['Diagnostic Test: Exercise Capacity']}, {'label': 'Obese Group (Boy)', 'description': 'Diagnosed with the obesity according to body mass index reference system, being 10-18 years old, being volunteer for the research and able to walk and cooperate are the inclusion criteria. Diagnosed with a neurological disease or another clinical diagnosis that may affect the cognitive state, musculoskeletal and neurological disease, symptomatic heart disease, lung disease, diabetes, hypertension and malignant disease, which may affect the performance of exercise and using the drug that affects appetite and weight are the exclusion criteria.', 'interventionNames': ['Diagnostic Test: Exercise Capacity']}, {'label': 'Control Group (Girl)', 'description': 'Being normal weight according to body mass index reference system, being 10-18 years old, being volunteer for the research and able to walk and cooperate are the inclusion criteria. Having comorbidities which may affect exercise performance and other physical tests, diagnosed with the cardiovascular problems, musculoskeletal and neurological diseases, cognitive or motor limitation or other chronic diseases are exclusion criteria.', 'interventionNames': ['Diagnostic Test: Exercise Capacity']}, {'label': 'Control Group (Boy)', 'description': 'Being normal weight according to body mass index reference system, being 10-18 years old, being volunteer for the research and able to walk and cooperate are the inclusion criteria. Having comorbidities which may affect exercise performance and other physical tests, diagnosed with the cardiovascular problems, musculoskeletal and neurological diseases, cognitive or motor limitation or other chronic diseases are exclusion criteria.', 'interventionNames': ['Diagnostic Test: Exercise Capacity']}], 'interventions': [{'name': 'Exercise Capacity', 'type': 'DIAGNOSTIC_TEST', 'description': 'Modified Shuttle Walk Test', 'armGroupLabels': ['Control Group (Boy)', 'Control Group (Girl)', 'Obese Group (Boy)', 'Obese Group (Girl)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'state': 'Samanpazari', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Ceren Iskenderoglu, Physical Therapist', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}, {'name': 'Deniz Inal Ince, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}, {'name': 'Melda Saglam, Associate Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}, {'name': 'Naciye Vardar Yagli, Associate Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}, {'name': 'Hazal Sonbahar Ulu, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}, {'name': 'Melis Pehlivanturk Kizilkan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ebru Calik Kutukcu', 'investigatorAffiliation': 'Hacettepe University'}}}}