Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-25 @ 3:18 PM
Study NCT ID:
NCT06805968
Status:
COMPLETED
Last Update Posted:
2025-02-03
First Post:
2025-01-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Exercise on Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2025-01-28', 'studyFirstSubmitQcDate': '2025-01-28', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smoking dependence level measurement', 'timeFrame': 'Duration of change in 1 day.', 'description': 'Meausered with Fagerström Nicotine Dependence Questionnaire (FNBA)'}, {'measure': 'FVC Measurement', 'timeFrame': 'Duration of change in 1 day.', 'description': 'Respiratory Function Test. The COSMED microQuark spirometer used. Lung volume was evaluated.'}, {'measure': 'FEV1 Measurement', 'timeFrame': 'Duration of change in 1 day.', 'description': 'Respiratory Function Test. The COSMED microQuark spirometer used. Lung volume was evaluated.'}], 'secondaryOutcomes': [{'measure': 'Cognitive status measurement with MOCA', 'timeFrame': 'Duration of change in 1 day.', 'description': 'Measured with Montreal Cognitive Function Assessment Scale (MOCA)'}, {'measure': 'Cognitive status measurement with Stroop Test', 'timeFrame': 'Duration of change in 1 day.', 'description': 'Measured with Stroop Test'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['smoker', 'aerobic', 'exercise'], 'conditions': ['Smokers']}, 'descriptionModule': {'briefSummary': 'When we look at the literature, although 202 results are found when "high intensity training" AND "aerobic" is written in the PUBMED database, 27 to 86 results are found when "high intensity training" AND "cognitive" and "high intensity training" AND "respiratory" are written and searched. 5 results are found when "high intensity training" AND "smoking" is searched, but there is no study investigating cognitive and respiratory functions, and no results are found when "high intensity training" AND "smoker" is searched. As far as is known, there is no study investigating the acute effect of high intensity aerobic exercise on respiratory functions and cognitive status in special education personnel who smoke. We aim to contribute to the literature with this original aspect of our study.', 'detailedDescription': 'Primary objective: The primary objective of the study is to investigate the acute effects of high-intensity aerobic exercise on respiratory functions in special education personnel who smoke.\n\nSecondary objective: The secondary objective of the study is to investigate the acute effects of high-intensity aerobic exercise on cognitive status in special education personnel who smoke.\n\nStudy questions\n\n* Is there an acute effect of high-intensity aerobic exercise on respiratory functions in special education personnel who smoke?\n* Is there an acute effect of high-intensity aerobic exercise on cognitive status in special education personnel who smoke?\n\nStudy Hypotheses:\n\nH0: There is no acute effect of high-intensity aerobic exercise on respiratory functions in special education personnel who smoke.\n\nH1: There is an acute effect of high-intensity aerobic exercise on respiratory functions in special education personnel who smoke.\n\nH2: There is no acute effect of high-intensity aerobic exercise on cognitive status in special education personnel who smoke.\n\nH3: High-intensity aerobic exercise has an acute effect on cognitive status in special education personnel who smoke.\n\nH4: High-intensity aerobic exercise has a greater acute effect on respiratory function and cognitive status in special education personnel who smoke than low-intensity training.\n\nH5: High-intensity aerobic exercise has a less acute effect on respiratory function and cognitive status in special education personnel who smoke than low-intensity training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteering to participate in the study\n* Participating in the Fageström Nicotine Dependence Questionnaire\n* No comorbidities\n* No comorbid diseases related to the orthopedic, neurological, cardiopulmonary system\n* Participants who have not participated in another clinical trial in the last month\n\nExclusion Criteria:\n\n* Participants who have had orthopedic and cardiopulmonary surgery in the last year\n* Those with cardiac or pulmonary system disease\n* Having sensory loss\n* Participants with leg length inequality'}, 'identificationModule': {'nctId': 'NCT06805968', 'briefTitle': 'Effect of Exercise on Smokers', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': 'Acute Effects of High Intensity Aerobic Exercise on Respiratory Function and Cognitive Status in Smoker Healthcare Workers', 'orgStudyIdInfo': {'id': 'E56365223-050.02.02.2023.13754'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'high-intensity aerobic exercise group', 'interventionNames': ['Other: High Intensity Exercise + Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'low-intensity aerobic exercise group', 'interventionNames': ['Other: Low Intensity Exercise + Placebo']}], 'interventions': [{'name': 'High Intensity Exercise + Placebo', 'type': 'OTHER', 'description': 'high intensity exercise', 'armGroupLabels': ['high-intensity aerobic exercise group']}, {'name': 'Low Intensity Exercise + Placebo', 'type': 'OTHER', 'description': 'low intensity exercise', 'armGroupLabels': ['low-intensity aerobic exercise group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Gedik University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Istanbul Gedik University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst. Prof.', 'investigatorFullName': 'ebrar atak', 'investigatorAffiliation': 'Istanbul Medipol University Hospital'}}}}