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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • Kayalı
      • Kırklareli, Kayalı, Turkey, 39000
        • Recruiting
        • Kirklareli University
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: Exercise
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
Other: Exercise
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kırklareli University

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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