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Respiratory Function, Physical Activity and Fatigue in SLE

M

Melis Usul

Status

Enrolling

Conditions

Systemic Lupus Erythematosus

Study type

Observational

Funder types

Other

Identifiers

NCT07193745
2025/05-1560

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

Individuals with systemic lupus erythematosus
Description:
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
Description:
Age- and sex-matched healthy participants without any medical conditions (including neurological, genetic, or psychiatric disorders) that would prevent them from completing the tests.

Trial contacts and locations

1

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Central trial contact

Zelal Apaydın, Msc; Melis Usul, Msc

Data sourced from clinicaltrials.gov

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