Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-01-01 @ 8:26 PM
Study NCT ID:
NCT07075068
Status:
RECRUITING
Last Update Posted:
2025-07-30
First Post:
2025-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Cigarette Addiction on Lower Extremity Movement Speed and Coordination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-07-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2025-07-10', 'studyFirstSubmitQcDate': '2025-07-18', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LEMOCOT Score (Lower Extremity Motor Coordination Test)', 'timeFrame': 'Baseline', 'description': 'The number of correct taps within 20 seconds will be measured for each participant.'}, {'measure': '30-Meter Sprint Time', 'timeFrame': 'Baseline', 'description': 'Time (in seconds) required to complete a 30-meter sprint will be recorded and averaged from two trials.'}], 'secondaryOutcomes': [{'measure': 'Fagerström Test for Nicotine Dependence Score', 'timeFrame': 'Baseline', 'description': 'Degree of nicotine dependence will be evaluated in smokers using the Fagerström Test for Nicotine Dependence.'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': 'Baseline', 'description': 'BMI will be calculated using height and weight measurements (BMI = weight (kg) / height² (m²)).'}, {'measure': 'Bimalleolar Circumference and Diameter Measurement', 'timeFrame': 'Baseline', 'description': 'The circumference at the level of the medial and lateral malleoli will be measured using a flexible tape measure while the participant is in a supine position.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'This observational study will aim to investigate the effects of cigarette addiction on lower extremity motor coordination and movement speed in young adults. The study will include healthy participants aged 18-25 years, divided into smokers and non-smokers. Motor coordination will be assessed using the Lower Extremity Motor Coordination Test (LEMOCOT), and speed will be evaluated with a 30-meter sprint test. Nicotine dependence will be evaluated in smokers using the Fagerström Test. The findings will provide insight into the possible functional impacts of nicotine addiction on motor performance.', 'detailedDescription': 'The study will be conducted as a non-randomized controlled observational trial at the Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. A total of 24 healthy young adults (12 smokers, 12 non-smokers) will participate. The inclusion criteria will require participants to be aged 18-25, cooperative, literate, and able to walk independently. Participants will be categorized as smokers based on WHO and DSM-IV-TR criteria. The primary assessments will include LEMOCOT and 30-meter sprint test. Nicotine addiction will be measured using the Fagerström Test for Nicotine Dependence (FTND), and anthropometric data including BMI and bimalleolar diameter will also be recorded. Data will be analyzed to determine any statistical differences or correlations between smoking status and motor performance outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of healthy young adults aged between 18 and 25 years. A total of 24 participants will be included, with 12 individuals who meet the criteria for cigarette dependence and 12 who do not smoke. Participants will be recruited from a university setting using convenience and snowball sampling methods. All participants will be required to be cooperative, literate, and able to walk independently. They will also be screened to ensure a body mass index (BMI) between 18.5 and 29.9 kg/m². Smokers will be identified based on the World Health Organization (WHO) definition and the DSM-IV-TR diagnostic criteria. Individuals with orthopedic, neurologic, cardiopulmonary, or cognitive impairments will be excluded.', 'eligibilityCriteria': 'Inclusion Criteria (for both groups):\n\n* Age between 18 and 25 years\n* Able to walk independently\n* Literate and cooperative\n* Willing to participate voluntarily\n* BMI between 18.5 and 29.9 kg/m²\n\nAdditional inclusion for smokers:\n\n* Daily smoking for at least one year based on WHO and DSM-IV-TR definitions\n* Exclusion Criteria (for all participants):\n* Orthopedic, neurologic, or neuromuscular disorders affecting gait\n* Chronic cardiopulmonary disease\n* Cognitive impairments\n* Obesity (BMI ≥ 30 kg/m²)\n\nAdditional exclusion for smokers:\n\n* History of acute cardiovascular events\n* Chronic heart failure or lung diseases'}, 'identificationModule': {'nctId': 'NCT07075068', 'briefTitle': 'The Effects of Cigarette Addiction on Lower Extremity Movement Speed and Coordination', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': 'The Effects of Cigarette Addiction on Lower Extremity Movement Speed and Coordination in Young Adults', 'orgStudyIdInfo': {'id': 'Smoking&Speed'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Smokers', 'description': 'Individuals who will meet WHO and DSM-IV-TR criteria for cigarette dependence.', 'interventionNames': ['Diagnostic Test: Behavioral and Functional Performance Assessment Battery']}, {'label': 'Non-Smokers', 'description': 'Individuals who will report no smoking behavior in the past year.', 'interventionNames': ['Diagnostic Test: Behavioral and Functional Performance Assessment Battery']}], 'interventions': [{'name': 'Behavioral and Functional Performance Assessment Battery', 'type': 'DIAGNOSTIC_TEST', 'description': 'This study will include only observational functional assessments. No active intervention will be performed.This observational protocol will involve standardized assessments of lower extremity coordination (LEMOCOT), movement speed (30-meter sprint), and smoking-related behavioral patterns (Fagerström Test for Nicotine Dependence). These tools will be used to evaluate the potential impact of cigarette addiction on physical performance in young adults. No therapeutic or pharmacological intervention will be applied.', 'armGroupLabels': ['Non-Smokers', 'Smokers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34668', 'city': 'Istanbul', 'state': 'Üsküdar', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'ESRA PEHLİVAN', 'role': 'CONTACT', 'email': 'fztesrakambur@yahoo.com', 'phone': '02164189616'}], 'facility': 'Esra Pehlivan', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'ESRA PEHLİVAN', 'role': 'CONTACT', 'email': 'fztesrakambur@yahoo.com', 'phone': '+90 777 87 77'}, {'name': 'Edanur Kocakaplan', 'role': 'CONTACT', 'email': '2103006006@ogrenci.sbu.edu.tr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'ESRA PEHLIVAN', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi'}}}}