Smoking Cessation Outcomes and Effective Factors

Smoking Cessation Clinical Trial

Official title:

Smoking Cessation Outcomes and Effective Factors: Maximal Voluntary Breath-holding Time and Exercise Capacity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05695742
• Other study ID #: Smoking
• Status: Completed
• Start date: January 23, 2023
• Est. completion date: September 27, 2023

Study information

• Verified date: January 2023
• Source: Saglik Bilimleri Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 893
• Est. completion date: September 27, 2023
• Est. primary completion date: September 27, 2023
• 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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Other:
• Active Smoking
Being active smoker
• Passive smoker
Being exposed to secondhand smoke
• Non-smoker
Not being an active or passive smoker.

Locations

Country	Name	City	State
Turkey	Esra Pehlivan	Istanbul	Üsküdar

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

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