Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
Study NCT ID:
NCT06650150
Status:
COMPLETED
Last Update Posted:
2025-08-08
First Post:
2024-10-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Respiratory Muscle Strength and Exercise Capacity in Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072277', 'term': 'Maximal Respiratory Pressures'}, {'id': 'D000070857', 'term': 'Walk Test'}], 'ancestors': [{'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D005080', 'term': 'Exercise Test'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2024-10-11', 'studyFirstSubmitQcDate': '2024-10-17', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '6MWT', 'timeFrame': 'day 1', 'description': '6MWT distance in each group'}], 'primaryOutcomes': [{'measure': 'MIP', 'timeFrame': 'day 1', 'description': 'MIP\\<80% in each grous'}], 'secondaryOutcomes': [{'measure': 'MEP', 'timeFrame': 'day 1', 'description': 'mep\\< 80% in each group'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PRISm', 'Pre-COPD', 'COPD', 'MIP', '6mwt'], 'conditions': ['COPD - Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'This cross-sectional study aims to evaluate the respiratory muscle strength and physical capacity of symptomatic adult smokers in Muğla. The study population will be the patients who were admitted to the pulmonary outpatient clinic of Muğla Training and Research Hospital between July 2024 and December 2024. The primary outcome is the proportion of individuals with Maximum Inspiratory Pressure (MIP) below 80%. Secondary outcomes include the 6-Minute Walk Test (6MWT) distance, Maximum Expiratory Pressure (MEP), and COPD Assessment Test (CAT) scores. Smokers will be categorized into COPD, PRISm, and Pre-COPD groups. The study will adjust for BMI as a key confounder and assess the modifying effects of gender, smoking habits, and age. Ethical approval and informed consent will be obtained, with data analysis focusing on descriptive statistics, comparative analysis, and regression models to understand the impact of smoking on respiratory health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of symptomatic smokers admitted to the pulmonary outpatient clinic of Muğla Training and Research Hospital between July 2024 and December 2024.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 5 packages of cigarette smokers who have an appropriate PFT done at our lab. (pulmonary function test must be performed at evaluable standards according to ERS/ATS guidelines)\n\nExclusion Criteria:\n\n* Respiratory infection at the time of measurement (upper or lower resp. tract, viral or bacterial infections)\n* Presence of chronic respiratory diseases (Asthma, IPF, Bronchiectasis, \\[except COPD\\])\n* Exacerbation due to chronic respiratory diseases (except mild COPD exacerbation)\n* Neuromuscular disease (ALS, Guillain-Bare syndrome, Muscular dystrophies, Myasthenia gravis)\n* Restrictive pulmonary disease (IPF, Sarcoidozis, Progresif Pulmonary Fibrosis)'}, 'identificationModule': {'nctId': 'NCT06650150', 'acronym': 'mip', 'briefTitle': 'Respiratory Muscle Strength and Exercise Capacity in Smokers', 'organization': {'class': 'OTHER', 'fullName': 'Muğla Sıtkı Koçman University'}, 'officialTitle': 'Comparative Study on Respiratory Muscle Strength and Exercise Capacity in Smokers With COPD, PRISm and Pre-COPD', 'orgStudyIdInfo': {'id': 'MIP24'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PRISm', 'description': 'cigarette smokers with FEV1 below 80%', 'interventionNames': ['Diagnostic Test: maximal inspiratory pressure', 'Diagnostic Test: maximal expiratory pressure', 'Diagnostic Test: 6 minute walk test']}, {'label': 'preCOPD', 'description': 'cigarette smokers with normal pft', 'interventionNames': ['Diagnostic Test: maximal inspiratory pressure', 'Diagnostic Test: maximal expiratory pressure', 'Diagnostic Test: 6 minute walk test']}, {'label': 'COPD', 'description': 'cigarette smokers with FEV1/FVC less than 70%', 'interventionNames': ['Diagnostic Test: maximal inspiratory pressure', 'Diagnostic Test: maximal expiratory pressure', 'Diagnostic Test: 6 minute walk test']}], 'interventions': [{'name': 'maximal inspiratory pressure', 'type': 'DIAGNOSTIC_TEST', 'description': 'maximal inspiratory pressure (mip) will be measured with a specific device', 'armGroupLabels': ['COPD', 'PRISm', 'preCOPD']}, {'name': 'maximal expiratory pressure', 'type': 'DIAGNOSTIC_TEST', 'description': 'MEP will be measured with a specific device', 'armGroupLabels': ['COPD', 'PRISm', 'preCOPD']}, {'name': '6 minute walk test', 'type': 'DIAGNOSTIC_TEST', 'description': '6mwt will be done by a phsyotherapist', 'armGroupLabels': ['COPD', 'PRISm', 'preCOPD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48000', 'city': 'Muğla', 'country': 'Turkey (Türkiye)', 'facility': 'Muğla Training and Research Hospital', 'geoPoint': {'lat': 37.21807, 'lon': 28.3665}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muğla Sıtkı Koçman University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sabri Serhan OLCAY', 'investigatorAffiliation': 'Muğla Sıtkı Koçman University'}}}}