Nicotine DependenceNCT06291558
Exercise Training for Smoking Students
A study testing Exercise in people with Nicotine Dependence and Smoking, run by Kırklareli University at 1 site in Turkey (Türkiye).
Trial summary
Smoking can damage lung functions as a result of high carbon monoxide and low hemoglobin oxygen carrying capacity in the blood. Smoking between young people continues to increase, which can cause respiratory function problems and lung diseases at an early age. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Smoking, Physical Inactivity
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 1 Oct 2024
- Phase
- Interventional
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signing the illuminated consent form,
- To be smoking at least 1 cigarette a day for the last 6 months,
- Not having orthopedic or neurological findings that can prevent the exercises included in the study,
- To have low-medium level physical activity level,
- Not to have any lower respiratory infection in the last 3 months.
Who cannot join
- To the exercise sessions to be held on time and not to arrive regularly
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kirklareli University
Kırklareli, Kayalı, 39000
Fulya DEMIRHAN, Res. Ass., +90-532-353-2208, fulyademirhan@klu.edu.tr
About this study
Official title: A Comparison of Exercise Education Outcomes Based on Nicotine Addiction Levels in Smoking Students
Smoking can damage lung functions as a result of high carbon monoxide and low hemoglobin oxygen carrying capacity in the blood. Smoking between young people continues to increase, which can cause respiratory function problems and lung diseases at an early age. In the studies, it has been seen that smoking may reduce the oppression and exercise ability.
Read the detailed description
Students who voluntarily accept participation in the study and sign the illuminated consent form, pulmonary status, gender, age, and body mass index to question data such as demographic data form, nicotine dependence levels Fagerstrom nicotine dependence scale, international physical activity scale (IPAQ), and Beck depression scale will be used. Then the respiratory function test will be evaluated with respiratory parameters and a 6-minute walking test. All evaluations made at the beginning of the study will be applied three times after the 8-week exercise program and the first month of control. First of all, the students will be grouped according to nicotine dependence levels, and exercise groups will be randomized according to each addiction level. Groups to be formed: Group 1: face-to-face exercise group; Group 2: online (telesağlık) exercise group; Group 3: control group.
- Conditions
- Nicotine Dependence, Smoking, Physical Inactivity, Depression
- Being tested
- Exercise
- Keywords
- resistance exercise, respiratory exercise, nicotine addiction, respiratory function test, telehealth
- Medical subject headings
- Tobacco Use Disorder, Smoking, Sedentary Behavior, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
The first 5 minutes of heating in the exercise program are planned to be implemented for 8 weeks, and the last 5 minutes are a cooling period. In the exercise program, which is planned to last 40 minutes in total, respiratory exercises will be applied to heating and cooling peryotes. As respiratory exercise, diaphragmatic respiratory exercise will be applied to heating and cooling peryots with 5 repetitions. Elastic resistant bands (Therand) will be used in resistant exercise training that will last for 30 minutes. The participants will be started to work with the resistance that they can do 10 again but cannot reach 14 repetitions. Elastic resistant bands are shoulder flexion, shoulder extension, shoulder ablution, shoulder horizontal abduction, elbow extension, hip ablution, hip flexion, and hip exercise. These exercises will be held once a week, 10 repetitions, 2 sets, for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Face to face Exercise Group | Experimental | In the face-to-face exercise group called Group 1, students will implement an exercise program of respiratory exercises and resistance exercises with the physiotherapist. Exercises will be held for 8 weeks Receives: Other: Exercise |
| Telehealth Exercise Group | Experimental | In the online (telehealth) exercise group, group 2 will be applied by the students with the help of the physiotherapist. Exercises will be held for 8 weeks Receives: Other: Exercise |
| Control Group | No intervention | In the control group called Group 3, students will not be given any exercise program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Physical Activity Questionnaire (Short)
It contains questions about the physical time spent in the last 7 days to learn about the physical activities of people in daily life. Metabolic equivalent (met) method was used to determine the level of physical activity. Standard Met values have been created for these activities. The daily and weekly physical activity level of the individual will be calculated by using the metal values determined for severe physical activity, moderate severe physical activity, walking and sitting.
Measured: Evaluation should be carried out before the start of treatment and 8 weeks after treatment.
Six-Minute Walk Test
It is a widely used test for evaluating the functional capacity of individuals. Individuals shall be requested to walk at normal walking speeds in a flat corridor of thirty meters long, with the start and end points determined for six minutes, and the distance in which the cases walk for six minutes shall be recorded in meters.
Measured: Evaluation should be carried out before the start of treatment and 8 weeks after treatment.
Scoring the Fagerstrom Test for Nicotine Dependence (FTND)
It is used to measure nicotine addiction. Points obtained from the scale, nicotine addiction level 0-2 Points: Very low level of nicotine addiction 3-4 points: low level of nicotine addiction, 5 points: moderate nicotine addiction, 6-7 points: high level of nicotine addiction, 8-10 points 8-10 points : It is classified as a very high level of nicotine addiction
Measured: Evaluation should be carried out before the start of treatment and 8 weeks after treatment.
Beck's Depression Inventory (BDI)
It is a scale applied to determine whether the person shows signs of depression. The scale consists of 21 items, and eleven items are divided into cognitions, two substances, two substances, five substances, physical symptoms, and one substance for individual symptoms. Each question is given to 0, 1, 2, or 3, and the patients are asked to choose the most appropriate one of these questions. A score between 0-63 is obtained. 0-9 no/minimal depression, 10-18 mild depression, 19-29 moderate depression, and 30-63 severe depression.
Measured: Evaluation should be carried out before the start of treatment and 8 weeks after treatment.
Lung Function Test
It allows the measurement of spirometry and pulmonary functions and the determination of abnormalities in the respiratory system. Spirometry shows the values obtained by exhalation and inhalation of air volumes during compulsory maneuvers. The main spirometry parameters are vital capacity (VC), challenging vital capacity (FVC), challenging expiratory volume in the first second (Fev1), and these parameters (Fev1/VC, Fev1/FVC).
Measured: Evaluation should be carried out before the start of treatment and 8 weeks after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Oct 2023
- Primary completion1 May 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fulya Demirhan, Kırklareli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291558
- Sponsor's protocol ID
- P202200027
- Status last verified
- Feb 2024
- First submitted
- 9 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Uysal MA, Kadakal F, Karsidag C, Bayram NG, Uysal O, Yilmaz V. Fagerstrom test for nicotine dependence: reliability in a Turkish sample and factor analysis. Tuberk Toraks. 2004;52(2):115-21.
PubMed 15241694American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.
PubMed 19204579Fagerstrom KO, Schneider NG. Measuring nicotine dependence: a review of the Fagerstrom Tolerance Questionnaire. J Behav Med. 1989 Apr;12(2):159-82. doi: 10.1007/BF00846549.
PubMed 2668531
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Exercise Education Outcomes Based on Nicotine Addiction Levels in Smoking Students
- ClinicalTrials.gov ID
- NCT06291558
- Acronym / sponsor ID
- P202200027
- Conditions
- Nicotine Dependence, Smoking, Physical Inactivity, Depression
- Keywords
- resistance exercise, respiratory exercise, nicotine addiction, respiratory function test, telehealth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 4 Mar 2024 (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.
Smoking can damage lung functions as a result of high carbon monoxide and low hemoglobin oxygen carrying capacity in the blood. Smoking between young people continues to increase, which can cause respiratory function problems and lung diseases at an early age. In the studies, it has been seen that smoking may reduce the oppression and exercise ability.
Detailed description
Students who voluntarily accept participation in the study and sign the illuminated consent form, pulmonary status, gender, age, and body mass index to question data such as demographic data form, nicotine dependence levels Fagerstrom nicotine dependence scale, international physical activity scale (IPAQ), and Beck depression scale will be used. Then the respiratory function test will be evaluated with respiratory parameters and a 6-minute walking test. All evaluations made at the beginning of the study will be applied three times after the 8-week exercise program and the first month of control. First of all, the students will be grouped according to nicotine dependence levels, and exercise groups will be randomized according to each addiction level. Groups to be formed: Group 1: face-to-face exercise group; Group 2: online (telesağlık) exercise group; Group 3: control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Face to face Exercise Group | Experimental | Other: ExerciseIn the face-to-face exercise group called Group 1, students will implement an exercise program of respiratory exercises and resistance exercises with the physiotherapist. Exercises will be held for 8 weeks |
| Telehealth Exercise Group | Experimental | Other: ExerciseIn the online (telehealth) exercise group, group 2 will be applied by the students with the help of the physiotherapist. Exercises will be held for 8 weeks |
| Control Group | No intervention | –In the control group called Group 3, students will not be given any exercise program. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Signing the illuminated consent form,
- To be smoking at least 1 cigarette a day for the last 6 months,
- Not having orthopedic or neurological findings that can prevent the exercises included in the study,
- To have low-medium level physical activity level,
- Not to have any lower respiratory infection in the last 3 months.
Key exclusion criteria (1 listed)
- To the exercise sessions to be held on time and not to arrive regularly
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 |
|---|---|---|
| ExerciseThe first 5 minutes of heating in the exercise program are planned to be implemented for 8 weeks, and the last 5 minutes are a cooling period. In the exercise program, which is planned to last 40 minutes in total, respiratory exercises will be applied to heating and cooling peryotes. As respiratory exercise, diaphragmatic respiratory exercise will be applied to heating and cooling peryots with 5 repetitions. Elastic resistant bands (Therand) will be used in resistant exercise training that will last for 30 minutes. The participants will be started to work with the resistance that they can do 10 again but cannot reach 14 repetitions. Elastic resistant bands are shoulder flexion, shoulder extension, shoulder ablution, shoulder horizontal abduction, elbow extension, hip ablution, hip flexion, and hip exercise. These exercises will be held once a week, 10 repetitions, 2 sets, for 8 weeks. | Other | Face to face Exercise Group, Telehealth Exercise Group |
Primary outcome
International Physical Activity Questionnaire (Short)
Time frame: Evaluation should be carried out before the start of treatment and 8 weeks after treatment.
It contains questions about the physical time spent in the last 7 days to learn about the physical activities of people in daily life. Metabolic equivalent (met) method was used to determine the level of physical activity. Standard Met values have been created for these activities. The daily and weekly physical activity level of the individual will be calculated by using the metal values determined for severe physical activity, moderate severe physical activity, walking and sitting.
Six-Minute Walk Test
Time frame: Evaluation should be carried out before the start of treatment and 8 weeks after treatment.
It is a widely used test for evaluating the functional capacity of individuals. Individuals shall be requested to walk at normal walking speeds in a flat corridor of thirty meters long, with the start and end points determined for six minutes, and the distance in which the cases walk for six minutes shall be recorded in meters.
Scoring the Fagerstrom Test for Nicotine Dependence (FTND)
Time frame: Evaluation should be carried out before the start of treatment and 8 weeks after treatment.
It is used to measure nicotine addiction. Points obtained from the scale, nicotine addiction level 0-2 Points: Very low level of nicotine addiction 3-4 points: low level of nicotine addiction, 5 points: moderate nicotine addiction, 6-7 points: high level of nicotine addiction, 8-10 points 8-10 points : It is classified as a very high level of nicotine addiction
Beck's Depression Inventory (BDI)
Time frame: Evaluation should be carried out before the start of treatment and 8 weeks after treatment.
It is a scale applied to determine whether the person shows signs of depression. The scale consists of 21 items, and eleven items are divided into cognitions, two substances, two substances, five substances, physical symptoms, and one substance for individual symptoms. Each question is given to 0, 1, 2, or 3, and the patients are asked to choose the most appropriate one of these questions. A score between 0-63 is obtained. 0-9 no/minimal depression, 10-18 mild depression, 19-29 moderate depression, and 30-63 severe depression.
Lung Function Test
Time frame: Evaluation should be carried out before the start of treatment and 8 weeks after treatment.
It allows the measurement of spirometry and pulmonary functions and the determination of abnormalities in the respiratory system. Spirometry shows the values obtained by exhalation and inhalation of air volumes during compulsory maneuvers. The main spirometry parameters are vital capacity (VC), challenging vital capacity (FVC), challenging expiratory volume in the first second (Fev1), and these parameters (Fev1/VC, Fev1/FVC).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Background: PubMed 15241694Uysal MA, Kadakal F, Karsidag C, Bayram NG, Uysal O, Yilmaz V. Fagerstrom test for nicotine dependence: reliability in a Turkish sample and factor analysis. Tuberk Toraks. 2004;52(2):115-21.
- Results publication: PubMed 19204579American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.
- Results publication: PubMed 2668531Fagerstrom KO, Schneider NG. Measuring nicotine dependence: a review of the Fagerstrom Tolerance Questionnaire. J Behav Med. 1989 Apr;12(2):159-82. doi: 10.1007/BF00846549.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Nicotine Dependence and Smoking, run by Kırklareli University 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fulya DEMIRHAN, Res. Ass. (+90-532-353-2208, fulyademirhan@klu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Physical Activity Questionnaire (Short) (time frame: Evaluation should be carried out before the start of treatment and 8 weeks after treatment.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06291558, which also lists 3 linked publications.
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 4 Mar 2024.