Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT07121218
Status:
RECRUITING
Last Update Posted:
2025-08-13
First Post:
2025-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Determination of Physical Fitness Level in Bronchiectasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001987', 'term': 'Bronchiectasis'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2025-08-03', 'studyFirstSubmitQcDate': '2025-08-08', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FitnessGram Physical Activity Test Battery', 'timeFrame': 'Baseline (day of enrollment) assessment'}, {'measure': 'Pulmonary function test', 'timeFrame': 'Baseline (day of enrollment) assessment'}, {'measure': 'Peripheral Muscle Strength', 'timeFrame': 'Baseline (day of enrollment) assessment'}], 'secondaryOutcomes': [{'measure': 'Physical Activity Level', 'timeFrame': 'Baseline (day of enrollment) assessment', 'description': "Physical activity level will be assessed using the Children's Physical Activity Questionnaire (CPAQ) developed by Kowalski et al. In this study, the Turkish version of the questionnaire, whose validity and reliability were established by Erdim et al., will be used . The scale evaluates physical activities (PA) performed in the past 7 days and their frequency. Responses are given on a five-point scale, where 5 indicates the highest and 1 the lowest level of physical activity. The total score of the questionnaire is calculated by averaging the scores from 9 questions. A higher score indicates a higher level of physical activity."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bronchiectasis', 'Physical Fitness'], 'conditions': ['Pediatric Patients With Bronchiectasis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the physical fitness level of children with bronchiectasis. To determine your physical fitness level, we will conduct some game-like tests. These are completely fun and enjoyable tests (such as running or a sit-to-stand test). Additionally, we will ask you some questions. These questions will help us get to know you better and understand how much you enjoy exercise. To measure your growth level, we will weigh you using a scale. We will also assess your muscle strength using a special device. All these tests will help us understand how much your condition affects you.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children aged 7 to 18 years diagnosed with bronchiectasis', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 7 to 18 years diagnosed with bronchiectasis\n* Able to walk, cooperative, and clinically stable\n* Children who can read and understand Turkish\n\nExclusion Criteria:\n\n* History of lung transplantation\n* Having experienced an acute exacerbation and/or hospitalization within the past month\n* Having a musculoskeletal pathology that may affect mobility\n* Presence of serious cardiac or neurological disease'}, 'identificationModule': {'nctId': 'NCT07121218', 'briefTitle': 'Determination of Physical Fitness Level in Bronchiectasis', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Kent University'}, 'officialTitle': 'Assessment of Physical Fitness Level and Its Relationship With Pulmonary Functions in Patients With Bronchiectasis', 'orgStudyIdInfo': {'id': 'E-10420511-051-43479'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Individuals with bronchiectasis'}, {'label': 'Healthy individuals'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Fatih', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Nilay Baş Specialist Physician', 'role': 'CONTACT', 'email': 'nilaybas@yahoo.com', 'phone': '05332689070'}], 'facility': 'Istanbul Faculty of Medicine', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'state': 'Hadımköy', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Universty Cerrahpaşa', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Gökşen Kuran Aslan Professor, Phd', 'role': 'CONTACT', 'email': 'goksenkuran@yahoo.com', 'phone': '05324095246'}, {'name': 'Melis Usul, Msc', 'role': 'CONTACT', 'email': 'melisausul1999@gmail.com', 'phone': '05364667235'}], 'overallOfficials': [{'name': 'Gökşen Kuran Aslan Professor, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul University - Cerrahpasa'}, {'name': 'Nilay Baş Specialist Physician', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul Medicine Faculty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Melis Usul', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': '**Specialist Physiotherapist**', 'investigatorFullName': 'Melis Usul', 'investigatorAffiliation': 'Istanbul Kent University'}}}}