- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06291558
Exercise Training for Smoking Students
February 26, 2024 updated by: Fulya Demirhan, Kırklareli University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fulya DEMIRHAN, Res. Ass.
- Phone Number: +90-532-353-2208
- Email: fulyademirhan@klu.edu.tr
Study Contact Backup
- Name: Burcu ÖZÜBERK, Assoc.prof.
- Phone Number: +90-507-555-13-44
- Email: burcuozuberk@klu.edu.tr
Study Locations
-
-
Kayalı
-
Kırklareli, Kayalı, Turkey, 39000
- Recruiting
- Kirklareli University
-
Contact:
- Fulya DEMIRHAN, Res. Ass.
- Phone Number: +90-532-353-2208
- Email: fulyademirhan@klu.edu.tr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- To the exercise sessions to be held on time and not to arrive regularly
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Face to face Exercise Group
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
|
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.
|
|
Experimental: Telehealth Exercise Group
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
|
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.
|
|
No Intervention: Control Group
In the control group called Group 3, students will not be given any exercise program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Evaluation should be carried out before the start of treatment and 8 weeks after treatment.
|
|
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.
|
Evaluation should be carried out before the start of treatment and 8 weeks after treatment.
|
|
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
|
Evaluation should be carried out before the start of treatment and 8 weeks after treatment.
|
|
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.
|
Evaluation should be carried out before the start of treatment and 8 weeks after treatment.
|
|
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).
|
Evaluation should be carried out before the start of treatment and 8 weeks after treatment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- American 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.
- 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.
- Fagerstrom 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2023
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
October 1, 2024
Study Registration Dates
First Submitted
February 9, 2024
First Submitted That Met QC Criteria
February 26, 2024
First Posted (Estimated)
March 4, 2024
Study Record Updates
Last Update Posted (Estimated)
March 4, 2024
Last Update Submitted That Met QC Criteria
February 26, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P202200027
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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