Respiratory Function, Physical Activity and Fatigue in SLE

NCT ID: NCT07193745

Last Updated: 2025-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-05

Study Completion Date

2025-10-30

Brief Summary

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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.

Detailed Description

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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

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Systemic Lupus Erythematosus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Melis Usul

OTHER

Sponsor Role lead

Responsible Party

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Melis Usul

Specialist Physiotherapist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ela Tarakçı, Professor

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Locations

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Istanbul University-Cerrahpasa

Istanbul, Fatih, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Melis Usul, Msc

Role: CONTACT

05364667235

Zelal Apaydın, Msc

Role: CONTACT

05395583859

Facility Contacts

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Serdal Uğurlu, Professor

Role: primary

05395583859

Other Identifiers

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2025/05-1560

Identifier Type: -

Identifier Source: org_study_id

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