Respiratory Function, Physical Activity and Fatigue in SLE

NCT07193745 | Completed

• 1 other identifier: 2025/05-1560
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Systemic Lupus Erythematosus

Keywords

respiratory function; functional capacity; systemic lupus erythematosus

Outcome Measures

Primary Outcomes (6)

• 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.

  Baseline (day of enrollment) assessment

Secondary Outcomes (1)

• Fatigue Level

  Baseline (day of enrollment) assessment

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals aged 18-65 years with a diagnosis of SLE

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Melis Usul: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Fatih, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ela Tarakçı, Professor

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist Physiotherapist

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 26, 2025
• Study Start: September 5, 2025
• Primary Completion: October 15, 2025
• Study Completion: November 30, 2025
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)