SmokingNCT07520981
Functional Capacity, Subjective Dyspnea and Fatigue in Smokers
An observational study of Smoking, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
Smoking remains a significant public health problem among the young adult population. Epidemiological studies in Turkey show a steadily decreasing age of smoking initiation and a remarkably high rate of smoking among university-aged individuals. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Assessment
- How many people
- 103 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2026to 15 Aug 2026
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study was planned to include volunteer individuals aged 18-30 who are university students and currently smoke.
Who may be able to join
- Being between 18 and 30 years of age.
- Being actively enrolled in university.
- Being a current smoker,
- Having been a regular smoker for at least the last 6 months,
- Having a daily cigarette consumption of ≥1 cigarette/day.
- Volunteering to participate in the study and providing written informed consent.
- Having the cognitive and physical capacity to understand and complete the tests to be administered.
Who cannot join
- Having a diagnosed chronic respiratory disease (asthma, COPD, bronchiectasis, interstitial lung disease, etc.),
- Having had an upper or lower respiratory tract infection within the last 4 weeks. Having a diagnosed heart disease (coronary artery disease, heart failure, arrhythmia, etc.),
- Having a history of uncontrolled hypertension.
- Having orthopedic problems affecting walking, sitting/standing, or balance,
- Having a history of lower extremity surgery or serious injury within the last 6 months.
- Having a history of neurological disease affecting balance, coordination, or motor control (stroke, multiple sclerosis, epilepsy, etc.).
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- Having a systemic disease that may prevent participation in exercise (uncontrolled diabetes, severe anemia, etc.),
- Being pregnant or within the first 6 months postpartum.
- Having conditions that may endanger the participant's safety during functional tests, o Refusal to complete the tests or inability to cooperate during the evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Functional Capacity and Subjective Dyspnea and Fatigue in Young Adult Smokers
Smoking remains a significant public health problem among the young adult population. Epidemiological studies in Turkey show a steadily decreasing age of smoking initiation and a remarkably high rate of smoking among university-aged individuals. Exposure to secondhand smoke is known to have negative effects on the respiratory system, cardiovascular system, and peripheral muscle function.
Impaired lung ventilation, reduced gas exchange, and insufficient oxygen transport due to smoking can lead to decreased exercise tolerance, premature fatigue, and increased perception of exertional dyspnea. These effects can manifest as a decrease in functional capacity even before the development of a clinically significant respiratory disease.
Read more
Functional capacity is an important indicator reflecting an individual's ability to perform daily living activities and is frequently assessed in clinical research using submaximal exercise tests. The 6-Minute Walk Test is a widely used, valid, and reliable test for assessing cardiorespiratory endurance and overall functional status. Similarly, the 1-Minute Sit-Stand Test is recommended as a practical and applicable method for evaluating lower extremity muscle endurance and functional performance.
Dyspnea is a multidimensional symptom reflecting an individual's subjective perception of respiratory discomfort and is assessed using scales such as the Modified Medical Research Council and the Borg Dyspnea Scale. The Turkish Thoracic Society's dyspnea assessment reports indicate that exertional dyspnea may increase in smokers even if respiratory function tests are within normal limits.
Fatigue, on the other hand, is a significant symptom that negatively affects an individual's daily living activities and physical functionality, arising from inflammatory processes, impaired oxygenation, and decreased physical activity levels associated with smoking. The Fatigue Severity Scale is a validated and reliable scale for assessing the impact of fatigue on an individual's physical and social life.
While studies in the literature examine the effects of smoking on respiratory function and exercise capacity, studies that address the relationship between functional capacity and subjective dyspnea and fatigue in young adult smokers are limited. In particular, evaluating functional test results such as the 6-Minute Walk Test and the 1-Minute Sit-Stand Test together with dyspnea and fatigue perception will contribute to the early identification of subclinical functional effects.
The aim of this study is to examine the relationships between functional capacity (6-Minute Walk Test, 1-Minute Sit-Stand Test, and Timed Up and Go Test) and subjective dyspnea (Modified Medical Research Council Scale - mMRC) and fatigue level (Fatigue Severity Scale) in young adult smokers aged 18-30 years. The findings of this study are expected to draw attention to the functional effects of smoking in young adults, contribute to the development of preventive health approaches, and facilitate the planning of physiotherapy-based assessment and intervention programs.
- Conditions
- Smoking
- Being tested
- Assessment
- Keywords
- functional capacity, subjectice dyspnea, fatigue, young adult smoker
- Medical subject headings
- Smoking, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentOther
In accordance with standard testing protocols, all participants will undergo the following assessments in order: Physical Activity Assessment (International Physical Activity Questionnaire), Functional Capacity Assessment (6-Minute Walk Test, 1-Minute Sit-to-Stand Test, and Timed Up and Go Test), Subjective Dyspnea Assessment (Modified Medical Research Council Dyspnea Scale), and Fatigue Severity Assessment (Fatigue Severity Scale).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Assessment group Receives: Other: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-Minute Walk Test
Participants will be asked to walk the longest possible distance in a straight corridor for 6 minutes. At the end of the test, the total walking distance will be recorded in meters. The test will be administered according to the standard protocol recommended by the American Thoracic Society.
Measured: 4 weeks
1-Minute Sit-Stand Test
Participants will be recorded on the number of times they stand up completely from a chair and sit down again within 60 seconds without using their arms. This test is a valid and reliable method for evaluating lower extremity muscle endurance and functional performance.
Measured: 4 weeks
Timed Up and Go Test
Participants will be asked to stand up from a chair, walk 3 meters, turn around, return to the starting point, and sit back down in the chair; the test duration will be recorded in seconds. The Timed Up and Go test is a widely used, valid, and reliable test for evaluating functional mobility, balance, and gait performance.
Measured: 4 weeks
Subjective Dyspnea Assessment
Participants' perception of dyspnea will be assessed using the Modified Medical Research Council Dyspnea Scale. The Modified Medical Research Council scale ranges from 0 to 4, with higher scores indicating greater perceived dyspnea severity. This scale is widely used to evaluate the level of dyspnea experienced during activities of daily living.
Measured: 4 weeks
Fatigue Assessment
Fatigue level will be assessed using the Fatigue Severity Scale. The Fatigue Severity Scale consists of 9 items, each scored on a scale from 1 to 7, and the final score is calculated as the mean of all items (range: 1-7). Higher scores indicate greater fatigue severity, and a mean score of ≥4 is considered clinically significant fatigue. The Turkish version of the FSS has been shown to be valid and reliable.
Measured: 4 weeks
Secondary outcomes (1)
Physical Activity Level
Participants' physical activity level will be assessed using the International Physical Activity Questionnaire - Short Form. Data will be expressed as MET-minutes/week, where higher values indicate higher levels of physical activity. Based on International Physical Activity Questionnaire - Short Form scoring guidelines, participants will be classified into low, moderate, and high physical activity levels.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start15 Apr 2026
- Primary completion30 Jul 2026
- Study completion15 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kubra Kardes, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520981
- Sponsor's protocol ID
- 2026/4
- Status last verified
- Aug 2026
- First submitted
- 3 Apr 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Functional Capacity and Subjective Dyspnea and Fatigue in Young Adult Smokers
- ClinicalTrials.gov ID
- NCT07520981
- Acronym / sponsor ID
- 2026/4
- Conditions
- Smoking
- Keywords
- functional capacity, subjectice dyspnea, fatigue, young adult smoker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 15 Aug 2026 (actual)
- First posted
- 9 Apr 2026 (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 remains a significant public health problem among the young adult population. Epidemiological studies in Turkey show a steadily decreasing age of smoking initiation and a remarkably high rate of smoking among university-aged individuals. Exposure to secondhand smoke is known to have negative effects on the respiratory system, cardiovascular system, and peripheral muscle function.
Impaired lung ventilation, reduced gas exchange, and insufficient oxygen transport due to smoking can lead to decreased exercise tolerance, premature fatigue, and increased perception of exertional dyspnea. These effects can manifest as a decrease in functional capacity even before the development of a clinically significant respiratory disease.
Functional capacity is an important indicator reflecting an individual's ability to perform daily living activities and is frequently assessed in clinical research using submaximal exercise tests. The 6-Minute Walk Test is a widely used, valid, and reliable test for assessing cardiorespiratory endurance and overall functional status. Similarly, the 1-Minute Sit-Stand Test is recommended as a practical and applicable method for evaluating lower extremity muscle endurance and functional performance.
Dyspnea is a multidimensional symptom reflecting an individual's subjective perception of respiratory discomfort and is assessed using scales such as the Modified Medical Research Council and the Borg Dyspnea Scale. The Turkish Thoracic Society's dyspnea assessment reports indicate that exertional dyspnea may increase in smokers even if respiratory function tests are within normal limits.
Fatigue, on the other hand, is a significant symptom that negatively affects an individual's daily living activities and physical functionality, arising from inflammatory processes, impaired oxygenation, and decreased physical activity levels associated with smoking. The Fatigue Severity Scale is a validated and reliable scale for assessing the impact of fatigue on an individual's physical and social life.
While studies in the literature examine the effects of smoking on respiratory function and exercise capacity, studies that address the relationship between functional capacity and subjective dyspnea and fatigue in young adult smokers are limited. In particular, evaluating functional test results such as the 6-Minute Walk Test and the 1-Minute Sit-Stand Test together with dyspnea and fatigue perception will contribute to the early identification of subclinical functional effects.
The aim of this study is to examine the relationships between functional capacity (6-Minute Walk Test, 1-Minute Sit-Stand Test, and Timed Up and Go Test) and subjective dyspnea (Modified Medical Research Council Scale - mMRC) and fatigue level (Fatigue Severity Scale) in young adult smokers aged 18-30 years. The findings of this study are expected to draw attention to the functional effects of smoking in young adults, contribute to the development of preventive health approaches, and facilitate the planning of physiotherapy-based assessment and intervention programs.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: AssessmentAssessment group |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study was planned to include volunteer individuals aged 18-30 who are university students and currently smoke.
Key inclusion criteria (7 listed)
- Being between 18 and 30 years of age.
- Being actively enrolled in university.
- Being a current smoker,
- Having been a regular smoker for at least the last 6 months,
- Having a daily cigarette consumption of ≥1 cigarette/day.
Key exclusion criteria (9 listed)
- Having a diagnosed chronic respiratory disease (asthma, COPD, bronchiectasis, interstitial lung disease, etc.),
- Having had an upper or lower respiratory tract infection within the last 4 weeks. Having a diagnosed heart disease (coronary artery disease, heart failure, arrhythmia, etc.),
- Having a history of uncontrolled hypertension.
- Having orthopedic problems affecting walking, sitting/standing, or balance,
- Having a history of lower extremity surgery or serious injury within the last 6 months.
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 |
|---|---|---|
| AssessmentIn accordance with standard testing protocols, all participants will undergo the following assessments in order: Physical Activity Assessment (International Physical Activity Questionnaire), Functional Capacity Assessment (6-Minute Walk Test, 1-Minute Sit-to-Stand Test, and Timed Up and Go Test), Subjective Dyspnea Assessment (Modified Medical Research Council Dyspnea Scale), and Fatigue Severity Assessment (Fatigue Severity Scale). | Other | Group 1 |
Primary outcome
6-Minute Walk Test
Time frame: 4 weeks
Participants will be asked to walk the longest possible distance in a straight corridor for 6 minutes. At the end of the test, the total walking distance will be recorded in meters. The test will be administered according to the standard protocol recommended by the American Thoracic Society.
1-Minute Sit-Stand Test
Time frame: 4 weeks
Participants will be recorded on the number of times they stand up completely from a chair and sit down again within 60 seconds without using their arms. This test is a valid and reliable method for evaluating lower extremity muscle endurance and functional performance.
Timed Up and Go Test
Time frame: 4 weeks
Participants will be asked to stand up from a chair, walk 3 meters, turn around, return to the starting point, and sit back down in the chair; the test duration will be recorded in seconds. The Timed Up and Go test is a widely used, valid, and reliable test for evaluating functional mobility, balance, and gait performance.
Subjective Dyspnea Assessment
Time frame: 4 weeks
Participants' perception of dyspnea will be assessed using the Modified Medical Research Council Dyspnea Scale. The Modified Medical Research Council scale ranges from 0 to 4, with higher scores indicating greater perceived dyspnea severity. This scale is widely used to evaluate the level of dyspnea experienced during activities of daily living.
Fatigue Assessment
Time frame: 4 weeks
Fatigue level will be assessed using the Fatigue Severity Scale. The Fatigue Severity Scale consists of 9 items, each scored on a scale from 1 to 7, and the final score is calculated as the mean of all items (range: 1-7). Higher scores indicate greater fatigue severity, and a mean score of ≥4 is considered clinically significant fatigue. The Turkish version of the FSS has been shown to be valid and reliable.
1 secondary outcome
Physical Activity Level
Time frame: 4 weeks
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 31 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Istinye 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 7 inclusion and 9 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 31 Aug 2026. 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?
6-Minute Walk Test (time frame: 4 weeks). 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?
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 31 Aug 2026.