Systemic Lupus ErythematosusNCT07193745
Respiratory Function, Physical Activity and Fatigue in SLE
An observational study of Systemic Lupus Erythematosus, run by Melis Usul at 1 site in Turkey (Türkiye).
Trial summary
Increasing awareness of possible pulmonary involvement in patients with systemic lupus erythematosus (SLE) will enable earlier diagnosis of the disease and minimize damage accumulation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Sep 2025to 30 Nov 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals aged 18-65 years with a diagnosis of SLE
Who may be able to join
- Patients who have been followed with a diagnosis of systemic lupus erythematosus for at least 1 year
- Able to ambulate independently
- No cognitive or mental impairment
- Willing to participate in the study
Who cannot join
- Presence of major musculoskeletal disease affecting the lower extremities
- Presence of severe disease affecting the cardiovascular system
- Being pregnant
- Smoking
- Having a diagnosis of restrictive/interstitial lung disease due to the underlying condition
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, Fatih
About this study
Official title: Respiratory Function, Functional Capacity, Physical Activity, and Fatigue in Patients With Systemic Lupus Erythematosus: A Cross-Sectional Study
Increasing awareness of possible pulmonary involvement in patients with systemic lupus erythematosus (SLE) will enable earlier diagnosis of the disease and minimize damage accumulation. According to our research, no study has been found that examines respiratory functions in detail in SLE patients and investigates their relationship with functional capacity, physical activity, and fatigue levels. Our primary aim is to compare respiratory functions, functional capacity, physical activity, and fatigue levels between patients with SLE and healthy controls. Our secondary aim is to investigate the relationship between respiratory functions with functional capacity, physical activity levels, and fatigue in SLE patients.
Read the detailed description
Systemic lupus erythematosus (SLE) is a chronic, inflammatory, autoimmune disease characterized by multisystem involvement. SLE can affect any organ or tissue, including the skin, joints, kidneys, central and peripheral nervous systems, lungs, and heart. Approximately 50% of patients with SLE may experience pulmonary involvement during the course of their disease. The most commonly reported manifestations in patients with SLE are pleurisy, diffuse alveolar hemorrhage, shrinking lung syndrome, interstitial lung disease, and pulmonary arterial hypertension.
Although estimates exist, the exact prevalence of pulmonary disease is unknown, and study findings have varied. In this context, our aim is to compare respiratory function, functional capacity, physical activity, and fatigue levels in patients with SLE with those in healthy controls. Our secondary aim is to investigate the relationship between respiratory function and functional capacity, physical activity level, and fatigue in patients with SLE.
Pulmonary function of the patients will be evaluated using pulmonary function tests. The level of physical activity of the participants will be assessed using the Global Physical Activity Questionnaire. Functional capacity will be evaluated with the 6-Minute Walk Test. Fatigue will be assessed using the Fatigue Severity Scale. Statistical analyses of the data obtained from the study will be performed using the Statistical Package for Social Sciences (SPSS) software.
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- respiratory function, functional capacity, systemic lupus erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with systemic lupus erythematosus | Individuals diagnosed with systemic lupus erythematosus according to the American College of Rheumatology classification criteria. Participants will be adults aged 18-65 years. | |
| Healthy individuals | Age- and sex-matched healthy participants without any medical conditions (including neurological, genetic, or psychiatric disorders) that would prevent them from completing the tests. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Vital Capacity (FVC)
The pulmonary function test will be performed using the COSMED Pony FX device in accordance with the American Thoracic Society and European Respiratory Society guidelines.
Measured: Time Frame: Baseline (day of enrollment) assessment
Forced Expiratory Volume (FEV1)
The pulmonary function test will be performed using the COSMED Pony FX device in accordance with the American Thoracic Society and European Respiratory Society guidelines.
Measured: Baseline (day of enrollment) assessment
Tiffeneau Index (FEV1/FVC)
The pulmonary function test will be performed using the COSMED Pony FX device in accordance with the American Thoracic Society and European Respiratory Society guidelines.
Measured: Baseline (day of enrollment) assessment
Peak Expiratory Flow (PEF)
The pulmonary function test will be performed using the COSMED Pony FX device in accordance with the American Thoracic Society and European Respiratory Society guidelines.
Measured: Baseline (day of enrollment) assessment
Functional Capacity
Functional capacity is assessed using the 6-Minute Walk Test according to the criteria of the American Thoracic Society. Participants are instructed to walk as fast as possible, but without running, at their own pace along a 30-meter flat corridor for 6 minutes. The distance covered is recorded in meters.
Measured: Time Frame: Baseline (day of enrollment) assessment
Physical Activity Level
The participants' physical activity status is assessed using the Global Physical Activity Questionnaire. The questionnaire consists of 16 questions. In the work and leisure activity sections, vigorous and moderate physical activities are assessed, while in the transportation section, moderate physical activities are assessed. In addition, there is an extra question for sedentary time. In each section, one yes/no question is followed by open-ended questions on the number of days per week and the duration per day. As a result of the questionnaire, the total weekly MET-minutes of physical activity are calculated. Moderate-intensity physical activities correspond to 4 MET/min, and vigorous-intensity physical activities correspond to 8 MET/min. Weekly total MET-minutes are calculated by multiplying with these coefficients.
Measured: Baseline (day of enrollment) assessment
Secondary outcomes (1)
Fatigue Level
Fatigue is assessed using the Fatigue Severity Scale. The scale consists of 9 items. Participants are asked to select a number from 1 to 7 for each statement, indicating the extent to which they agree with it (1: strongly disagree; 7: strongly agree). The scores obtained for all items are summed and then divided by nine to calculate the final score. A score of four or higher generally indicates severe fatigue.
Measured: Baseline (day of enrollment) assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start5 Sep 2025
- Primary completion15 Oct 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melis Usul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Melis Usul, Istanbul Kent University
- Investigators
- Ela Tarakçı, Professor, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193745
- Sponsor's protocol ID
- 2025/05-1560
- Status last verified
- Mar 2026
- First submitted
- 15 Sep 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Function, Functional Capacity, Physical Activity, and Fatigue in Patients With Systemic Lupus Erythematosus: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07193745
- Acronym / sponsor ID
- 2025/05-1560
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- respiratory function, functional capacity, systemic lupus erythematosus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Melis UsulUniversity, hospital or other
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 26 Sep 2025 (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.
Increasing awareness of possible pulmonary involvement in patients with systemic lupus erythematosus (SLE) will enable earlier diagnosis of the disease and minimize damage accumulation. According to our research, no study has been found that examines respiratory functions in detail in SLE patients and investigates their relationship with functional capacity, physical activity, and fatigue levels. Our primary aim is to compare respiratory functions, functional capacity, physical activity, and fatigue levels between patients with SLE and healthy controls. Our secondary aim is to investigate the relationship between respiratory functions with functional capacity, physical activity levels, and fatigue in SLE patients.
Detailed description
Systemic lupus erythematosus (SLE) is a chronic, inflammatory, autoimmune disease characterized by multisystem involvement. SLE can affect any organ or tissue, including the skin, joints, kidneys, central and peripheral nervous systems, lungs, and heart. Approximately 50% of patients with SLE may experience pulmonary involvement during the course of their disease. The most commonly reported manifestations in patients with SLE are pleurisy, diffuse alveolar hemorrhage, shrinking lung syndrome, interstitial lung disease, and pulmonary arterial hypertension.
Although estimates exist, the exact prevalence of pulmonary disease is unknown, and study findings have varied. In this context, our aim is to compare respiratory function, functional capacity, physical activity, and fatigue levels in patients with SLE with those in healthy controls. Our secondary aim is to investigate the relationship between respiratory function and functional capacity, physical activity level, and fatigue in patients with SLE.
Pulmonary function of the patients will be evaluated using pulmonary function tests. The level of physical activity of the participants will be assessed using the Global Physical Activity Questionnaire. Functional capacity will be evaluated with the 6-Minute Walk Test. Fatigue will be assessed using the Fatigue Severity Scale. Statistical analyses of the data obtained from the study will be performed using the Statistical Package for Social Sciences (SPSS) software.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with systemic lupus erythematosus | – | –Individuals diagnosed with systemic lupus erythematosus according to the American College of Rheumatology classification criteria. Participants will be adults aged 18-65 years. |
| Healthy individuals | – | –Age- and sex-matched healthy participants without any medical conditions (including neurological, genetic, or psychiatric disorders) that would prevent them from completing the tests. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals aged 18-65 years with a diagnosis of SLE
Key inclusion criteria (4 listed)
- Patients who have been followed with a diagnosis of systemic lupus erythematosus for at least 1 year
- Able to ambulate independently
- No cognitive or mental impairment
- Willing to participate in the study
Key exclusion criteria (5 listed)
- Presence of major musculoskeletal disease affecting the lower extremities
- Presence of severe disease affecting the cardiovascular system
- Being pregnant
- Smoking
- Having a diagnosis of restrictive/interstitial lung disease due to the underlying condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Forced Vital Capacity (FVC)
Time frame: Time Frame: Baseline (day of enrollment) assessment
The pulmonary function test will be performed using the COSMED Pony FX device in accordance with the American Thoracic Society and European Respiratory Society guidelines.
Forced Expiratory Volume (FEV1)
Time frame: Baseline (day of enrollment) assessment
The pulmonary function test will be performed using the COSMED Pony FX device in accordance with the American Thoracic Society and European Respiratory Society guidelines.
Tiffeneau Index (FEV1/FVC)
Time frame: Baseline (day of enrollment) assessment
The pulmonary function test will be performed using the COSMED Pony FX device in accordance with the American Thoracic Society and European Respiratory Society guidelines.
Peak Expiratory Flow (PEF)
Time frame: Baseline (day of enrollment) assessment
The pulmonary function test will be performed using the COSMED Pony FX device in accordance with the American Thoracic Society and European Respiratory Society guidelines.
Functional Capacity
Time frame: Time Frame: Baseline (day of enrollment) assessment
Functional capacity is assessed using the 6-Minute Walk Test according to the criteria of the American Thoracic Society. Participants are instructed to walk as fast as possible, but without running, at their own pace along a 30-meter flat corridor for 6 minutes. The distance covered is recorded in meters.
Physical Activity Level
Time frame: Baseline (day of enrollment) assessment
The participants' physical activity status is assessed using the Global Physical Activity Questionnaire. The questionnaire consists of 16 questions. In the work and leisure activity sections, vigorous and moderate physical activities are assessed, while in the transportation section, moderate physical activities are assessed. In addition, there is an extra question for sedentary time. In each section, one yes/no question is followed by open-ended questions on the number of days per week and the duration per day. As a result of the questionnaire, the total weekly MET-minutes of physical activity are calculated. Moderate-intensity physical activities correspond to 4 MET/min, and vigorous-intensity physical activities correspond to 8 MET/min. Weekly total MET-minutes are calculated by multiplying with these coefficients.
1 secondary outcome
Fatigue Level
Time frame: Baseline (day of enrollment) assessment
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 24 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Ela Tarakçı, Professor study director
Istanbul University - Cerrahpasa
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 Systemic Lupus Erythematosus, run by Melis Usul 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 4 inclusion and 5 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 24 Mar 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?
Forced Vital Capacity (FVC) (time frame: Time Frame: Baseline (day of enrollment) assessment). The study lists 6 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 24 Mar 2026.