- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05695742
Smoking Cessation Outcomes and Effective Factors
Smoking Cessation Outcomes and Effective Factors: Maximal Voluntary Breath-holding Time and Exercise Capacity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is a cross-sectional-descriptive study. Cases who met the inclusion criteria, agreed to participate in the study voluntarily, were active smokers, passive smokers and non-smokers will be included. Active smoking, passive smoking status and non-smoker status of the cases will be determined within the framework of the definitions given below.
- Active smoker: Having smoked at least 1 cigarette per day for at least 2 years.
- Passive smoker: Being exposed to secondhand smoke for more than 15 minutes at home, school, office or anywhere in the past year, once a week.
- Non-smoker: Not being an active or passive smoker.
The subjects will be given the maximal voluntary breath-hold test, the 6-minute walk test, and the 30-second sit-and-stand test, and will be asked to answer questions about smoking.The physical conditions of the groups will be compared.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Üsküdar
-
İstanbul, Üsküdar, Turkey, 34668
- Esra Pehlivan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria for Active Smokers
- Being between the ages of 18-75
- Smoking at least 1 cigarette a day for at least 2 years
Inclusion Criteria for the Passive Smoker Group
- Being between the ages of 18-75
- Being exposed to cigarette smoke for more than 15 minutes at home, school, office or anywhere in the last year, once a week.
Inclusion Criteria for the Non-Smoker Group
- Being between the ages of 18-75
- Not being an active or passive smoker
Exclusion Criteria:
- Having any disease that prevents him from doing exercise tests
- Not signing the voluntary informed consent form
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Active smokers
Having smoked at least 1 cigarette per day for at least 2 years.
|
Being active smoker
|
|
Pasive smokers
Being exposed to secondhand smoke for more than 15 minutes at home, school, office or anywhere in the past year, once a week.
|
Being exposed to secondhand smoke
|
|
Non-smokers
Not being an active or passive smoker.
|
Not being an active or passive smoker.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Six-minute walking test
Time Frame: 1 day
|
The subject will be asked to walk for 6 minutes on a flat surface of 30 meters and the distance covered will be recorded.
The test will be performed in accordance with the American Thoracic Society guidelines
|
1 day
|
|
Maximal voluntary breath-hold time
Time Frame: 1 day
|
The maximum voluntary breath-hold test is a quick and simple test that consists of measuring the apnea time after a deep inspiration.
The clinical utility of this test has been proven in certain respiratory pathologies.
In the test, the subject will be seated in a chair with back support, a deep inspiration will be asked, and the breath-holding time will be recorded in seconds.
The test will be repeated three times with sufficient rest periods in between, and the longest time will be analyzed.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Thirty Seconds Sit and Stand test
Time Frame: 1 day
|
During the test, the individual performs the sit-stand-sit maneuver from a standard height chair within 30 seconds without using his arms as much as possible.
The number of sitting and standing up during this period is recorded.
|
1 day
|
|
Fagerstrom Nicotine Addiction Test
Time Frame: 1 day
|
Dependence analysis will be performed on smokers according to the Fagerström nicotine addiction test and the scales for evaluating the psychological dependence of cigarettes.
It is a six-question questionnaire created by revising the Fagerstrom tolerance questionnaire.
In the scoring made according to the answers given to the questions, 0-2 points is called very mild addiction and 8-10 points is called very severe addiction
|
1 day
|
|
Evaluation scale of psychological dependence on cigarette
Time Frame: 1 day
|
It is a scale used in the evaluation of psychological dependence on cigarettes.
The possible scores range from 25 to 75.
As the scale score increases, the degree of psychological dependence increases; Scoring; 25-41 score: mildly addicted 42-58 score: moderate addiction
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: ESRA PEHLİVAN, Saglik Bilimleri Universitesi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Smoking
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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