Smoking CessationNCT05695742
Smoking Cessation Outcomes and Effective Factors
An observational study of Smoking Cessation, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Active Smoking, Passive smoker and Non-smoker
- How many people
- 893 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jan 2023to 27 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Active, pasive smoker and non-smoker volunters
Who may be able to join
- Being between the ages of 18-75
- Smoking at least 1 cigarette a day for at least 2 years
- 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.
- Being between the ages of 18-75
- Not being an active or passive smoker
Who cannot join
- Having any disease that prevents him from doing exercise tests
- Not signing the voluntary informed consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smoking Cessation Outcomes and Effective Factors: Maximal Voluntary Breath-holding Time and Exercise Capacity
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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Active Smoking, Passive smoker, Non-smoker
- Keywords
- smoking, active smoking, pasive smoking, exercise capacity, maximal voluntary breath holding, Fagerstrom
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active SmokingOther
Being active smoker
Passive smokerOther
Being exposed to secondhand smoke
Non-smokerOther
Not being an active or passive smoker.
| Study group | Role | What they receive |
|---|---|---|
| Active smokers | Having smoked at least 1 cigarette per day for at least 2 years. Receives: Other: Active Smoking | |
| 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. Receives: Other: Passive smoker | |
| Non-smokers | Not being an active or passive smoker. Receives: Other: Non-smoker |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
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.
Measured: 1 day
Secondary outcomes (3)
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.
Measured: 1 day
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
Measured: 1 day
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start23 Jan 2023
- Primary completion27 Sep 2023
- Study completion27 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 893 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ESRA PEHLİVAN, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05695742
- Sponsor's protocol ID
- Smoking
- Status last verified
- Jan 2023
- First submitted
- 26 Dec 2022
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation Outcomes and Effective Factors: Maximal Voluntary Breath-holding Time and Exercise Capacity
- ClinicalTrials.gov ID
- NCT05695742
- Acronym / sponsor ID
- Smoking
- Conditions
- Smoking Cessation
- Keywords
- smoking, active smoking, pasive smoking, exercise capacity, maximal voluntary breath holding, Fagerstrom
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 893 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active smokers | – | Other: Active SmokingHaving smoked at least 1 cigarette per day for at least 2 years. |
| Pasive smokers | – | Other: Passive smokerBeing exposed to secondhand smoke for more than 15 minutes at home, school, office or anywhere in the past year, once a week. |
| Non-smokers | – | Other: Non-smokerNot being an active or passive smoker. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Active, pasive smoker and non-smoker volunters
Key inclusion criteria (6 listed)
- Being between the ages of 18-75
- Smoking at least 1 cigarette a day for at least 2 years
- 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.
- Being between the ages of 18-75
Key exclusion criteria (2 listed)
- Having any disease that prevents him from doing exercise tests
- Not signing the voluntary informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active SmokingBeing active smoker | Other | Active smokers |
| Passive smokerBeing exposed to secondhand smoke | Other | Pasive smokers |
| Non-smokerNot being an active or passive smoker. | Other | Non-smokers |
Primary outcome
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
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.
3 secondary outcomes
Thirty Seconds Sit and Stand test
Time frame: 1 day
Fagerstrom Nicotine Addiction Test
Time frame: 1 day
Evaluation scale of psychological dependence on cigarette
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ESRA PEHLİVAN principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Cessation, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-minute walking test (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023; AzTrials last refreshed its copy on 6 Nov 2026.