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Completed

NCT Number: NCT07193745

Respiratory Function, Physical Activity and Fatigue in SLE

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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University-Cerrahpasa

Istanbul, Fatih, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. Fatigue Level

    Time frame: Baseline (day of enrollment) assessment

    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.

Sponsors and collaborators

Lead sponsor

Melis Usul

Other

Registry information

Official study title

Respiratory Function, Functional Capacity, Physical Activity, and Fatigue in Patients With Systemic Lupus Erythematosus: A Cross-Sectional Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2025
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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