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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals aged 18-65 years with a diagnosis of SLE
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| Name | Affiliation | Role |
|---|---|---|
| Ela Tarakçı, Professor | Istanbul University - Cerrahpasa | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University-Cerrahpasa | Istanbul | Fatih | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Baseline (day of enrollment) assessment |
| Baseline (day of enrollment) assessment |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |