Effects of Nicotine Dependence on Multidimensional Health Outcomes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIzmir Democracy University
About this trial
Nicotine, a major toxic component of cigarette smoke, together with carbon monoxide (CO), constitutes a significant environmental exposure with systemic effects. Beyond its addictive potential, chronic nicotine exposure may induce inflammation, oxidative stress, tissue hypoxia, and autonomic imbalance, potentially impairing respiratory muscle strength, functional capacity, and overall physical performance. Additionally, nicotine dependence has been associated with sleep disturbances, cognitive dysfunction, altered pain perception, and reduced quality of life.
Although previous studies have examined individual effects of smoking on specific health outcomes, research addressing these multidimensional impacts within a comprehensive framework remains limited. Therefore, this study aims to investigate the relationship between nicotine dependence level and respiratory muscle strength, functional capacity, cognitive functions, pain, quality of life, physical activity level, and sleep quality, in order to provide a more holistic understanding of the clinical consequences of nicotine dependence.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Regular cigarette use for at least the past 6 months
No history of respiratory, cardiovascular, or neurological/psychiatric disease
No recent history of surgery or trauma that could affect respiratory muscles
No current acute infection (especially upper or lower respiratory tract infections)
Disqualifiers
Presence of chronic respiratory diseases such as COPD or
History of cardiovascular disease
Diagnosed neurological or psychiatric disorders
history of surgery or trauma affecting the respiratory muscles within the last 3 months
Trial design
Design model
Single group
Treatments tested in this trial
Comprehensive Clinical Assessment
Other interventionParticipants will undergo a comprehensive clinical assessment including evaluation of nicotine dependence level (Fagerström Test for Nicotine Dependence), respiratory muscle strength (MIP, MEP), functional capacity (6-Minute Walk Test), cognitive function (MoCA), pain (VAS and SF-MPQ), quality of life (SF-36), physical activity level (IPAQ-SF), sleep quality (PSQI), addiction behavior model (SOCRATES), and health beliefs (Health Belief Model Scale). No therapeutic intervention will be administered.
Treatment groups
212 Participants
are divided into 1 treatment groupGroup A: Adult SmokersOther 1 intervention
Trial outcomes
Primary outcomes
1
Assessment of Nicotine Dependence
Nicotine dependence will be assessed using the Fagerström Test for Nicotine Dependence (FTND). The test was originally developed by Karl O. Fagerström, and its Turkish validity and reliability study was conducted in 2003. The FTND consists of six items. The total score obtained from participants' responses determines the level of nicotine dependence. Scores of 0-2 indicate very low dependence, 3-4 low dependence, 5 moderate dependence, 6-7 high dependence, and 8-10 very high dependence. This evaluation provides an important criterion for determining the need for intervention related to cigarette dependence.
Time frame
At baseline2
Maximal Inspiratory Pressure (MIP)
Maximal inspiratory pressure will be measured using the Pony-Fx pulmonary function testing device according to ATS/ERS standards. Assessments will be performed in the seated position with a nose clip. At least three maneuvers will be obtained, and the highest value will be used for analysis. Unit of measure: cmH2O.
Time frame
At baseline3
Maximal Expiratory Pressure (MEP)
Maximal expiratory pressure will be measured using the Pony-Fx pulmonary function testing device according to ATS/ERS standards. Assessments will be performed in the seated position with a nose clip. At least three maneuvers will be obtained, and the highest value will be used for analysis. Unit of measure: cmH2O.
Time frame
At baseline4
Assessment of Functional Capacity
Functional capacity will be assessed using the 6-Minute Walk Test (6MWT) in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines. Participants will perform the test in a 30-meter corridor. Two tests will be conducted, and the longer walking distance will be used for analysis. Rest periods will be permitted and included in the total test duration. The walked distance will be expressed in meters (m). Predicted walking distance values will be calculated using standard reference equations.
Time frame
At baselineSponsors and contacts
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Source ClinicalTrials.gov
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