Clinical trial NCT06680570: Smoking and Health Among University Students
Official title: Pulmonary capacıty, physıcal actıvıty Level and Headaches in Smokers and Non-smokers: ınsıghts From a unıversıty Student Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease
Headache Disorders
Sedentary Behavior
Physical Activity Level
Keywords: Smoking
Headache
Students
Sedentary behavior
Lead sponsor: University of Yalova
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: young people

Brief summary: The goal of this observational study is to explore the associations between pulmonary capacity, physical activity levels, and headache occurrence in university students aged 18-30, focusing on differences between smokers and non-smokers. The main questions it aims to answer are:

Is there a relationship between pulmonary function (FEV1 and FVC measurements) and the frequency of headaches in university students? How do physical activity levels and sedentary behavior differ between smokers and non-smokers, and how do these factors correlate with headache prevalence? Researchers will compare smokers and non-smokers to see if smoking influences CO levels, sedentary behavior, and respiratory function, contributing to a higher incidence of headaches.

Participants will:

Complete pulmonary function tests using handheld spirometers to measure FEV1 and FVC.

Fill out the International Physical Activity Questionnaire (IPAQ-SF) to assess physical activity and sedentary behavior.

Use the Headache Impact Test (HIT-6) to evaluate headache impact on daily life. Provide carbon monoxide (CO) breath levels for analysis.

Detailed description: This observational study investigates the relationships between pulmonary function, physical activity levels, and headache prevalence in university students, with a specific focus on the impacts of smoking. Conducted at Yalova University in Turkey, the study includes a diverse cohort of students aged 18-30, separated into two groups: smokers and non-smokers. By examining the physical health profiles and lifestyle behaviors of these students, the research aims to understand how smoking might affect respiratory function, activity levels, and the incidence of headaches within this population.

Objectives

The primary objectives are:

To determine whether pulmonary function (measured through FEV1 and FVC) is associated with headache occurrence and severity.

To assess the difference in sedentary behavior and physical activity levels between smokers and non-smokers and how these factors correlate with headache prevalence.

To analyze how elevated carbon monoxide (CO) levels from smoking affect respiratory capacity and contribute to headache incidence.

Methods

The study employs a cross-sectional design and utilizes several standardized tools for data collection:

Pulmonary Function Tests (PFTs): FEV1 (Forced Expiratory Volume in 1 second) and FVC (Forced Vital Capacity) values are recorded using a handheld spirometer. These tests provide an objective measure of lung capacity, which may be impacted by smoking.

International Physical Activity Questionnaire (IPAQ-SF): This validated questionnaire is used to assess physical activity levels, categorizing participants into low, moderate, or high activity levels, while also measuring sedentary behavior.

Headache Impact Test (HIT-6): This self-reported tool is administered to gauge the impact of headaches on daily life, allowing researchers to classify headache severity and its interference with student activities.

CO Breath Test: To assess smoking intensity, CO levels are measured using a breath analyzer, providing a clear, quantifiable indication of recent exposure to cigarette smoke.

Study Population and Exclusion Criteria Participants include male and female students aged 18-30 who are non-smokers or regular smokers. Exclusion criteria include individuals with pre-existing respiratory or cardiovascular conditions, recent respiratory infections, or recent surgeries. Students with diagnosed respiratory diseases (e.g., COPD, asthma) are excluded to ensure a focus on otherwise healthy individuals within the target age range.

Expected Outcomes

The study hypothesizes that:

Reduced lung function (lower FEV1 and FVC values) correlates with an increased frequency and severity of headaches, particularly among smokers.

Higher CO levels in smokers will be associated with greater headache prevalence and lower physical activity levels.

Sedentary behavior will be more common among non-smokers and may contribute to an increased incidence of headaches in this subgroup.

Significance The findings of this study are anticipated to provide valuable insights into the health impacts of smoking on young adults, particularly within the context of respiratory and neurological health. By establishing correlations between smoking, lung function, physical activity, and headaches, the study aims to inform targeted interventions for university students. Future public health initiatives may benefit from these findings by addressing sedentary behavior and smoking habits as key factors affecting the well-being of young adults in educational settings.

Eligibility criteria: Inclusion Criteria:

Being Yalova University students Aged between18-30 years

Exclusion Criteria:

Participants showing signs or diagnosed with respiratory conditions such as tuberculosis, post-tuberculosis lung disease, bronchial asthma, Chronic Obstructive Pulmonar Disease, or valvular heart disease were excluded

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Primary outcomes:
measure: Forced vital capacity (FVC)
timeFrame: 10 month
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: 10 month
measure: Headache Impact Test (HIT-6)
timeFrame: 10 month
measure: Physical Activity Assessment (IPAQ-SF)
timeFrame: 10 month
measure: Carbon Monoxide (CO) Level
timeFrame: 10 month
Secondary outcomes:
Other outcomes:
Locations:
city: Yalova
country: Turkey
facility: asuman SALTAN
Study officials:
affiliation: Yalova Unıversity
name: asuman SALTAN
role: PRINCIPAL_INVESTIGATOR
References: