NCT06680570

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 8, 2024

Completed
Last Updated

November 8, 2024

Status Verified

November 1, 2024

Enrollment Period

7 months

First QC Date

November 5, 2024

Last Update Submit

November 7, 2024

Conditions

Keywords

SmokingHeadacheStudentsSedentary behavior

Outcome Measures

Primary Outcomes (5)

  • Forced vital capacity (FVC)

    FVC spirometry tests (liters) used to measure lung capacity among both smoker and non-smoker students.

    10 month

  • Forced Expiratory Volume in 1 second (FEV1)

    FEV1 spirometry tests (liters) used to measure lung capacity among both smoker and non-smoker students.

    10 month

  • Headache Impact Test (HIT-6)

    Headache Impact Test questionnaire used to assess the impact of headaches on daily life.

    10 month

  • Physical Activity Assessment (IPAQ-SF)

    The International Physical Activity Questionnaire Short Form (IPAQ-SF) used to evaluate physical activity levels and sedentary behavior among students.

    10 month

  • Carbon Monoxide (CO) Level

    Measurement of carbon monoxide levels (Part Pers Million (ppm)) in exhaled breath to assess exposure from smoking.

    10 month

Study Arms (1)

smokers

Group: smokers Smokers Description: This group consists of university students who smoke regularly. Lung capacity, physical activity levels, carbon monoxide (CO) breath values and headache frequency will be measured and evaluated. This group was included in the study to examine the effect of smoking on these health parameters. Non-Smokers Description: This group consists of non-smoking university students. Lung capacity, physical activity levels and headache frequency of non-smokers will be measured and compared with the smoking group. This group was included to analyse the relationship between lung function and headache in non-smokers.

Diagnostic Test: Pulmonary Function Testing, Carbon Monoxide (CO) Breath Testing

Interventions

Pulmonary Function Testing FEV1 and FVC spirometry tests used to measure lung capacity among both smoker and non-smoker students. Carbon Monoxide (CO) Breath Testing Measurements taken using a CO breath analyzer to assess CO levels in the smoker group. Physical Activity Assessment (IPAQ-SF) The International Physical Activity Questionnaire Short Form (IPAQ-SF) used to evaluate physical activity levels and sedentary behavior among students. Headache Impact Test (HIT-6) HIT-6 questionnaire used to assess the impact of headaches on daily life.

Also known as: Headache Impact Test (HIT-6), Physical Activity Assessment (IPAQ-SF)
smokers

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

young people

You may qualify if:

  • Being Yalova University students Aged between18-30 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

asuman SALTAN

Yalova, 77200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung DiseasesHeadache DisordersSedentary BehaviorSmokingHeadache

Interventions

Respiratory Function Tests

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehaviorPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • asuman SALTAN

    University of Yalova

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
10 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2024

First Posted

November 8, 2024

Study Start

January 1, 2021

Primary Completion

August 1, 2021

Study Completion

January 1, 2022

Last Updated

November 8, 2024

Record last verified: 2024-11

Locations