Smoking Cessation Clinical Trial
Official title:
Smoking Cessation Outcomes and Effective Factors: Maximal Voluntary Breath-holding Time and Exercise Capacity
NCT number | NCT05695742 |
Other study ID # | Smoking |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 23, 2023 |
Est. completion date | September 27, 2023 |
Verified date | January 2023 |
Source | Saglik Bilimleri Universitesi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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. 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.
Status | Completed |
Enrollment | 893 |
Est. completion date | September 27, 2023 |
Est. primary completion date | September 27, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Esra Pehlivan | Istanbul | Üsküdar |
Lead Sponsor | Collaborator |
---|---|
Saglik Bilimleri Universitesi |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Six-minute walking test | 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 | |
Primary | Maximal voluntary breath-hold time | 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 | Thirty Seconds Sit and Stand test | 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 | |
Secondary | Fagerstrom Nicotine Addiction Test | 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 | |
Secondary | Evaluation scale of psychological dependence on cigarette | 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 |
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